Implementation of the US PRECISION AIRQ, Asthma Checklist, and Educational Resources (PRECISION Program) Into Clinical Practice Using Telehealth and In-Person Platforms
Phase: NA
Conditions: Asthma
Sponsor: AstraZeneca

Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
1 
 Study Protocol 
Study Code 
D2287L00028 [EVA-26645-03] 
Version 
2.0 
Date 
June 16, 2022 
D2287L00028 
Implementation of the US PRECISION AIRQ
, Asthma Checklist, and 
Educational Resources (PRECISION Program) into Clinical Practice Using 
Telehealth and In-Person Platforms 
Sponsor: 
AstraZeneca Pharmaceuticals, LP 
Author: 
AZ PRECISION Team 
  
1800 Concord Pike 
Wilmington, DE  19803 
PPD
PPD
PPD
PPD
Redacted
028
028
on o
n
ed for 
the US P
he US
urces (PREC
urces (PR
erson Platfo
rson Pla
Public 
AstraZeneca Ph
AstraZenec
P
Z PRECISION Te
ECISION
d Pike
d Pike
 19803 
19803 
Pub
ublblic Disclosure
D

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
2 
TABLE OF CONTENTS 
PAGE 
TITLE PAGE ........................................................................................................... 1 
TABLE OF CONTENTS ......................................................................................... 2 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ............................ 6 
RESPONSIBLE PARTIES ...................................................................................... 7 
PROTOCOL SYNOPSIS ......................................................................................... 8 
AMENDMENT HISTORY ................................................................................... 14 
MILESTONES ....................................................................................................... 15 
1. 
BACKGROUND AND RATIONALE .................................................................. 16 
1.1 
Background ............................................................................................................ 16 
1.2 
Rationale ................................................................................................................ 16 
2. 
OBJECTIVES AND HYPOTHESES .................................................................... 17 
2.1 
Primary Objective & Hypothesis ........................................................................... 17 
2.2 
Secondary Objectives ............................................................................................. 17 
2.3 
Exploratory Objectives .......................................................................................... 18 
3. 
METHODOLOGY................................................................................................. 19 
3.1 
Study Design  General Aspects ............................................................................ 19 
3.1.1 
Data Source(s) ........................................................................................................ 21 
3.2 
Study Population .................................................................................................... 21 
3.3 
Inclusion Criteria.................................................................................................... 22 
3.4 
Exclusion Criteria .................................................................................................. 22 
4. 
VARIABLES AND EPIDEMIOLOGICAL MEASUREMENTS ........................ 22 
4.1 
Exposures ............................................................................................................... 22 
4.1.1 
Patient Verbal Informed Consent Scripts............................................................... 22 
4.1.2 
 .................................................................................................................. 22 
4.1.3 
Clinical Case Report Form ..................................................................................... 23 
4.1.4 
Follow-up Clinical Clinical Case Report Form (CRF) .......................................... 23 
4.1.5 
12-Month Post-Initial Visit Exacerbation Clinical Case Report Form 
(CRF) ..................................................................................................................... 23 
4.1.6 
Study Website ........................................................................................................ 23 
4.1.7 
Asthma Checklist ................................................................................................... 24 
4.1.8 
PRECISION Educational Resources ..................................................................... 24 
4.1.9 
Asthma Clinic Experience (ACE) Questionnaire .................................................. 24 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
3 
4.1.10 
.............................................................. 24 
4.1.11 
4.1.12 
Patient Sociodemographics Questionnaire ............................................................. 25 
4.1.13 
Clinical Site Touchpoint Questions ....................................................................... 25 
4.1.14 
Post-study Survey .................................................................................................. 25 
4.1.15 
Semi-structured Interview Guide ........................................................................... 25 
4.2 
Outcomes ............................................................................................................... 26 
4.2.1 
Primary Outcome ................................................................................................... 26 
4.2.2 
Secondary Outcome ............................................................................................... 26 
4.2.3 
Exploratory Outcomes ........................................................................................... 27 
4.3 
Other Variables and Covariates ............................................................................. 28 
5. 
STATISTICAL ANALYSIS PLAN ...................................................................... 29 
5.1 
Statistical Methods  General Aspects ................................................................... 29 
5.1.1 
Primary Objective(s): Assess the Process and Potential Benefit of 
(PRECISION program) into Clinical Practice during Telehealth and In-
Person Visits .......................................................................................................... 29 
5.1.2 
Secondary Objective(s): To Assess Patient Visit Satisfaction When the 
-Person visit with Their 
HCP ........................................................................................................................ 29 
5.1.3 
Exploratory Objective(s):
 
 ...................................................................... 30 
5.2 
Bias......................................................................................................................... 31 
5.2.1 
Methods to Minimize Bias ..................................................................................... 31 
5.2.2 
Adjustment for Multiple Comparisons .................................................................. 31 
5.2.3 
Strengths and Limitations ...................................................................................... 31 
5.3 
Sample Size and Power Calculations ..................................................................... 31 
6. 
STUDY CONDUCT AND REGULATORY DETAILS ....................................... 32 
6.1 
Study Conduct ........................................................................................................ 32 
6.1.1 
Study Flow Chart and Plan for Telehealth or In-Person Visits.............................. 32 
6.1.2 
Procedures .............................................................................................................. 34 
6.1.3 
Quality Control ...................................................................................................... 37 
6.1.3.1 
Responsibilities ...................................................................................................... 37 
6.1.3.2 
ePRO Programming and Hosting ........................................................................... 40 
6.1.3.3 
DataFax CRF and Database Setup ......................................................................... 40 
6.1.3.4 
Database Management ........................................................................................... 40 
6.2 
Protection of Human Subjects ................................................................................ 41 
6.2.1 
Patient Informed Consent....................................................................................... 41 
6.2.2 
Health Care Practioner and Key Clinical Site Staff Informed Consent ................. 42 
6.2.3 
Confidentiality of Study/Participant Data .............................................................. 42 
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
4 
6.3 
Collection and Reporting of Adverse Events/Adverse Drug Reactions ................ 43 
7. 
LIST OF REFERENCES ....................................................................................... 45 
APPENDIX A. PATIENT VERBAL INFORMED CONSENT SCRIPTS 
 ........................................................ 46 
APPENDIX B. PATIENT VERBAL INFORMED CONSENT SCRIPTS 
 ........................................................ 47 
APPENDIX C. PATIENT VERBAL INFORMED ASSENT/CONSENT 
SCRIPTS (FOR < 18 YEARS) (ENGLISH VERSION) ....................................... 48 
APPENDIX D. PATIENT VERBAL INFORMED CONSENT SCRIPTS 
(FOR < 18 YEARS) (SPANISH VERSION) ........................................................ 48 
 .................................................. 49 
 .................................................. 50 
-MONTH RECALL (ENGLISH VERSION) .............. 51 
APPENDIX H. 
-MONTH RECALL (SPANISH VERSION) .............. 52 
APPENDIX I. CLINICAL CASE REPORT FORM (CRF) .................................. 53 
APPENDIX J. FOLLOW-UP CRFS ..................................................................... 60 
APPENDIX K. PRECISION SUPPLEMENTAL ONLINE 
EDUCATIONAL RESOURCES ........................................................................... 66 
APPENDIX L. ASTHMA CLINIC EXPERIENCE (ACE) 
QUESTIONNAIRE (ENGLISH VERSION) ........................................................ 75 
APPENDIX M. ASTHMA CLINIC EXPERIENCE QUESTIONNAIRE 
(SPANISH VERSION) .......................................................................................... 76 
  
 77 
 
 78 
........... 79 
.... 80 
APPENDIX R. PATIENT SOCIODEMOGRAPHICS QUESTIONNAIRE 
(ENGLISH VERSION).......................................................................................... 81 
APPENDIX S. PATIENT SOCIODEMOGRAPHICS QUESTIONNAIRE 
(SPANISH VERSION) .......................................................................................... 83 
APPENDIX T. CLINICAL SITE TOUCH POINT QUESTIONS........................ 84 
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
5 
APPENDIX U. POST-STUDY SURVEY............................................................. 85 
APPENDIX V. SEMI-STRUCTURED INTERVIEW GUIDES .......................... 88 
............ 93 
APPENDIX X. ADVERTISEMENT .................................................................... 94 
APPENDIX Y. RECRUITMENT TRACKING LOG ........................................... 95 
APPENDIX Z. E-MAIL FOR POST VISIT PATIENT SURVEY 
(ENGLISH VERSION).......................................................................................... 96 
APPENDIX AA. E-MAIL FOR POST VISIT PATIENT SURVEY 
(SPANISH VERSION) .......................................................................................... 96 
APPENDIX BB.  REMINDER E-MAILS FOR POST VISIT PATIENT 
SURVEY (ENGLISH VERSION) ......................................................................... 97 
APPENDIX CC. REMINDER E-MAILS FOR POST VISIT PATIENT 
SURVEY (SPANISH VERSION) ......................................................................... 98 
APPENDIX DD. DESCRIPTION OF DRUGS IN EACH DRUG CLASS .......................... 99 
8. 
SIGNATURES ..................................................................................................... 101 
 
 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
6 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation or 
special term 
Explanation 
ACE 
Asthma Clinic Experience Questionnaire 
AE 
Adverse event 
 
Asthma Impairment and Risk Questionnaire 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CRF 
Case Report Form 
ePRO 
Electronic patient-reported outcome 
ED 
Emergency department 
FDA 
Food and Drug Administration 
FQHC 
Federally qualified health care 
GCP 
Good Clinical Practice 
GINA 
Global Initiative for Asthma 
HCP 
Healthcare practitioner 
HIPAA 
Health Insurance Portability and Accountability Act 
HRQOL 
Health-related quality of life 
ICH 
International Council for Harmonisation 
ID 
Identification 
IEC 
Independent ethics committee 
IRB 
Institutional review board 
NAEPP 
National Asthma Education and Prevention Program 
OCR 
Optical character recognition 
OCS 
Oral corticosteroids 
 
 
PCP 
Primary care provider 
ROC 
Receiver operating characteristic 
SD 
Standard deviation 
SOP 
Standard operating procedure 
SUA 
Severe uncontrolled asthma 
US 
United States 
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
7 
RESPONSIBLE PARTIES 
Name 
Professional Title 
Role in Study 
Affiliation 
E-mail Address 
 
 
  
 
 
Co-Team Lead 
AstraZeneca 
  
 
 
Medical Lead 
AstraZeneca 
 
 
 
 
 
Study Lead
AstraZeneca
 
 
 
Statistician 
AstraZeneca 
  
 
 
Co-Principal 
Investigator 
Evidera 
 
 
 
Co-Principal 
Investigator 
Evidera 
 
 
 
Project 
Manager 
Evidera 
 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
8 
PROTOCOL SYNOPSIS 
 
Implementation of 
Educational Resources (PRECISION Program) into Clinical Practice using Telehealth 
and In-Person Platforms 
 
 
Background/Rationale:  The AstraZeneca US PRECISION initiative formed an advisor 
network of scientific and clinical experts and healthcare practitioners (HCP) to develop a 
point-of-care tool
the 
for the 
identification of patients at risk for adverse outcomes from uncontrolled asthma. To date, the 
AIR
a variety of clinical practices (i.e. allergy, pulmonary and primary care) was evaluated in a 
pilot program that was well-received by patients and demonstrated the ease of use by clinical 
staff.  A cross-sectional validation study was conducted that demonstrated the validity of the 
-
record documented prior-
points for levels 
 consists of 10 
yes/no items with the total score used to identify patients at risk for poor asthma outcomes. 
This study aims to evaluate the implementation of 
educational resources (PRECISION program) in clinical practice using telehealth and in-
person platforms. 
Objectives and Hypotheses: 
The primary objective of this study is: 
1. To assess the process (ease of use and challenges to HCPs and patients) and potential 
benefits (ability to capture and take action to remediate previously unrecognized 
morbidity) of implementing 
 Asthma Checklist, and educational 
resources (PRECISION program) into clinical practice during telehealth and in-person 
visits. 
The secondary objectives of this study are: 
1. T
clinic 
the Asthma 
Checklist, and educational resources (PRECISION program) are utilized as part of a 
telehealth or in-person visit with their HCP; 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
9 
2. 
-up visit(s) (when 
available). 
The following are exploratory objectives: 
1.
 
 
 
 
 
 
 
   
 
 
 
This study is descriptive and there will be no formal hypothesis testing for the primary 
objective. 
Methods: 
Study design: This community program intervention study will examine the process of 
ces (PRECISION program) 
into clinical practice using either in-person or telehealth visits. Providers use of p
, and educational resources to guide treatment and 
asthma work-up and management also will be examined. The study duration is 12-months, 
with study enrollment lasting nine (9) months for each site (implementation stage), and an 
additional three (3) months of follow-up to assess the sustainability of using the PRECISION 
CCI
CCI
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
10 
program in clinical practice (sustainability stage). The nine-month implementation stage will 
allow for the recruitment of approximately 50 patients at each site for an initial study visit, 
plus the potential for follow-up visit(s). The three-month sustainability stage will allow for 
sites to continue to implement the PRECISION program in their clinical practice and for sites 
to describe any continued benefits of using the PRECISION program at their site. 
Approximately fifteen (15) to twenty (20) clinical sites will be recruited to participate in this 
study, categorized into the following three practice clusters: (1) primary care site (e.g., private 
practice, FQHC; (2) specialty care site (pulmonary, asthma/immunology); and (3) novel sites 
(e.g., pharmacy, nurse practitioners, nurse educators, prescribers and Non-prescribers, 
telehealth component of Allergy and Asthma Network). While all sites will be able to conduct 
both in-person and telehealth visits, sites will aim to conduct a minimum of approximately 
25% of their initial patient visit using a telehealth platform. Both platforms (in-person and 
telehealth) can be used for the follow-up visit(s) for all practice types. 
During the clinic visit (telehealth or in-person), HCPs will assess the 
 questions, discuss the results with the patient, and use the Assess component of the 
Asthma Checklist (as appropriate per HCP judgment).  Before completing the initial study 
visit, patients will be asked if they would be willing to complete additional questions and, for 
those who agree, sites will send them an electronic survey link (via YouGov) which will 
include the following questionnaires: the Asthma Clinic Experience (ACE) Questionnaire, 
and a Patient 
Sociodemographics Questionnaire. If a follow-up visit (telehealth or in-person) is conducted 
during the follow-up period
-month recall 
version (regardless of timing of follow-up visit). Sites/HCPs will complete a Clinical Case 
Report Form (CRF) after the initial visit and after the follow-up visit (if conducted) for each 
participant.  It should be noted that for all visits (initial and follow up), HCPs will be required 
to review the Assess component of the Asthma Checklist and provide their responses on the 
CRF; the Adjust and Review components of the Asthma Checklist will be available, along 
with the other PRECISION resources, on the study website as well, but will not be mandatory 
to complete,
  
Additionally, Evidera will host a 30-minute conference call with each clinical site for up to 
four (4) time points (touchpoints) to discuss the implementation of PRECISION tools (i.e., 
frequency of visits to and the number of PDF views from study website), assess whether sites 
are meeting their targets for using the telehealth platform, address site questions, and discuss 
any challenges of implementing the PRECISION program. These meetings will take place at 
Months 1, 2, 3 (optional), and 6 and will also be used to identify any sites that may benefit 
from participating in a re-training session. The optional Month 3 touchpoint will be based on 
whether the site is having any difficulties with the study.  
Study Population: Clinic staff will invite patients age >13 years with HCP-confirmed asthma 
diagnosis who are presenting for a clinic visit (telehealth or in-person) to complete the 
and participant questionnaires. Each site will aim to recruit approximately 50 patients 
with a total sample size ranging from approximately 750 to 1,500 patients. 
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
11 
Inclusions Criteria: 
Patients must meet all of the following criteria to be eligible for enrollment: 
1. > 13 years of age at the time of enrollment 
2. Prior diagnosis of HCP confirmed asthma 
3. Able to read, understand, and speak English or Spanish sufficiently to self-
complete or be 
, desktop computer, or 
mobile device (e.g., smartphone, iPad) 
4. Provide consent (adults/parents/guardians) and assent (age 13-17 years) to 
participate in the study 
Exclusion Criteria:  
Patients meeting any of the following criteria will not be included in the study: 
1. Current diagnosis of active COPD or any lower respiratory diagnosis other than 
asthma. 
2. Has a cognitive impairment, hearing difficulty, acute psychopathology, medical 
condition, or insufficient knowledge of the English or Spanish language that, in 
the opinion of the investigator, would interfere with his or her ability to agree 
to participate and/or complete the AIRQTM or other study questionnaires. 
 
Data Source(s): Approximately fifteen (15) to twenty (20) clinical sites will be selected to 
implement the AI
into clinical practice using telehealth and in-person platforms. The sites will be selected based 
as part of their care practice, the number of asthma patients visiting the clinic via telehealth 
per week, the diversity of the asthma patients treated by the clinic, the ability of the site to 
complete the study tasks in the allotted timeframe, and the anticipated unique component(s) 
used to contribute to the implementation process by the study site. Each site will be 
responsible for recruiting approximately 50 asthma patients per site. 
Exposure(s): 
Patients will complete the following measures: 
 
 12-month 
 
 3-month Recall (as appropriate) 
 ACE Questionnaire (for those who agree; initial visit only) 
 
 
 Patient Sociodemographics Questionnaire (for those who agree; initial visit 
only) 
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
12 
HCPs will complete the following measures: 
 Clinical Case Report Form (CRF) 
 Follow-up Clinical CRF (if appropriate) 
 Clinal Site Touchpoint Questions (via telephone) 
 Post-study Survey  
 Qualitative Interview  
 12-Month Post-Initial Visit Exacerbation CRF (when applicable) 
Outcome(s): 
 Qualitative interview responses  
 Post-study Survey responses 
 Touchpoint findings 
 ACE Questionnaire responses 
 
 
 
 
 
 Relationship between HCP actions (e.g. step up/step down/no change in 
therapy, referral to specialist, initiation of biologic) based on assessment 
component of Asthma Checklist and AIRQTM scores 
 AIRQ
 
 
Sample Size Estimations: As the primary aim of this study is to assess the process and 
feasibility of implementing the AIRQ
, Asthma Checklist, and education resources 
(PRECISION program) using a telehealth or in-person platform, inferential statistics will not 
be conducted as part of the primary endpoint, and a formal sample size estimation is not 
applicable. Each site will target approximately 50 patients with asthma. Implementing the 
AIRQ
, Asthma Checklist, and educational resources (PRECISION program) among 
approximately 50 patients per site will provide sites with enough experience to provide 
feedback on the outcomes, barriers, benefits, challenges, ease of implementation, and areas for 
improvement for future integration as a telehealth platform. 
Statistical Analysis: Descriptive statistics (n, frequency, mean, SD) will be used to 
characterize the sample in terms of sociodemographic and clinical characteristics. The 
sociodemographic and clinical characteristics will be summarized for the sample overall as 
well as for each site and cluster. Descriptive statistics (n, frequency, mean, SD) will also be 
used to summarize the actions of HCPs (e.g., actions accessed/taken, step up/step down/no 
change in therapy, referral to a specialist, initiation of biologics), results from the 
responses on the Post-study Survey
ACE Questionnaire and the 
,  AIRQ
 scores,
 
CCI
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
13 
 The relationships between AIRQTM scores and specific outcomes (e.g., HCP actions 
taken/accessed, referrals to specialists, initiation of biologics) will be explored.  Change in 
 visit and follow-up visit(s) 
-Month 
Recall) will be explored when available by site and cluster. 
Qualitative interviews will be 
 and transcriptions. 
Audio-recordings of interviews from clinical site personnel will be referred to as necessary to 
supplement interviewer notes. The interview results will be summarized in tabular format, 
with key advantages, and disadvantages grouped. Additionally, findings from the 
implementation questions discussed during the clinical site touchpoint meetings will be 
integrated into the findings from the interviews. Facilitators, challenges and barriers, ease of 
implementation, and areas for improvement will be summarized. 
 
 
 
 
  
All analyses will be detailed in a Statistical Analysis Plan.  Additional exploratory analyses 
may be performed to further examine specific aspects of available clinical data. 
 
 
 
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
14 
AMENDMENT HISTORY 
Date 
Section of study protocol 
Amendment or update 
Reason 
June 
16 
2022 
 
1 
Revision of exploratory 
outcome 6 and removal of 
exploratory outcome 7. 
Update of site sample size 
maximum limit  
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
15 
MILESTONES 
Milestone 
Planned end date 
Final Protocol 
Q1 2021 
IRB Study Protocol Approval 
Q1 2021 
Site Trainings 
June 18, 2021 
First Site In
February 15, 2021
First Subject In 
March 15, 2021 
Last Site in 
June 15, 2021 
Interviews with Site Principal Investigators/Key Staff 
Mar 15, 2022 
Database Lock 
Q2 2022 
High-Level Results in Tabular Format 
Q3 2022 
Final Report  
September 26, 2022 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
16 
1. 
BACKGROUND AND RATIONALE 
1.1 
Background 
Uncontrolled and severe uncontrolled asthma (SUA) are under-identified and sub-optimally 
treated. The clinical and economic burden of SUA is disproportionately high, accounting for 
nearly 40% of asthma-related costs (Moore et al. 2007; Nunes et al. 2017); uncontrolled 
asthma affects more than 50% of children and adults with asthma. With advances in asthma 
therapies, an urgent need exists to optimize uncontrolled and SUA recognition and primary 
care management; and when indicated, referral to qualified specialists. 
The AstraZeneca United States (US) PRECISION initiative formed an advisor network of 
scientific and clinical experts, as well as healthcare practitioners (HCPs), to develop a point-
of-care tool
the Asthma Impairment and Risk Questionnaire
 (AIRQ
). This is designed 
to identify patients living with asthma whose health may be at risk from uncontrolled asthma, 
and to facilitate shared decision-making between patients and HCPs. The AIRQ
 is intended 
to be completed by patients before or at their HCP telehealth, or during an in-person clinic 
visit and includes questions that address medication use, asthma symptoms, exacerbations, 
hospitalizations, and asthma-related impairment. 
items, with the total score and control categories used to identify patients at risk for poor 
asthma outcomes. All response options are in an easy yes/no format. In addition to the 
, HCPs are provided with the Asthma Checklist and supplemental educational 
resources, based on the Global Initiative for Asthma (GINA) guidelines, National Asthma 
Education and Prevention Program Guidelines (2007; 2020), and key expert reviews on 
asthma assessment and management to facilitate decision-making and developed by 
PRECISION Advisors and approved by the AstraZeneca Medical Information and 
Promotional Regulatory Affairs teams. 
The AIRQ
, Asthma Checklist, and educational resources are for use among patients 12 
years old with an asthma diagnosis and are designed for all HCPs to use following provider 
experience and comfort level. These resources are meant to assist providers in recognizing, 
evaluating, and optimizing care for patients with uncontrolled or SUA. They are not intended 
to be treatment directive or diagnostic, but rather to support HCPs in moving toward precision 
medicine in practice. 
1.2 
Rationale 
To date, the AIRQ
 has been qualitatively evaluated among patients in an interview setting 
to ensure that it is understandable and easy to complete. The feasibility of implementing the 
AIRQ
 into a variety of clinical practices (i.e., allergy, pulmonary, and primary care) was 
evaluated in a pilot program that was well-received by patients and demonstrated the ease of 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
17 
use by clinical staff. A cross-sectional validation study was conducted to validate the AIRQ
 
relative to a composite of the Asthma Control Test
 (ACT
) score, plus medical-record 
documented prior-year exacerbations to derive the final AIRQ
 items, scoring, and cut points 
of varying levels of asthma control (Murphy et al. 2020). The final AIRQ
 consists of 10 
yes/no items, with the total score and control categories used to identify patients at risk for 
poor asthma outcomes. 
The AIRQ
 performs well in identifying patients who are well controlled vs. not well/very 
poorly controlled (with receiver operating characteristic [ROC] curves of 0.93 for the 0 to 10 
summed score model) and identifies well/not well controlled vs. very poorly controlled 
asthma (ROC curves of 0.90 for the 0 to 10 summed score model), as reflected by the 
-
for separating well-controlled vs. all others, with a specificity of 0.96 for separating very 
poorly controlled from all others. A longitudinal study is being conducted to assess the 
predictive ability of the AIRQ
 as a screening tool for predicting future exacerbations as well 
as health-related quality of life (HRQoL). 
This study aims to evaluate the implementation of the AIRQ
, Asthma Checklist, and 
educational resources (PRECISION program) into clinical practice using telehealth and in-
person platforms. 
2. 
OBJECTIVES AND HYPOTHESES 
2.1 
Primary Objective & Hypothesis 
The primary objective of this study is to assess the process (ease of use and challenges to 
HCPs and patients) and potential benefits (ability to capture and take action to remediate 
ist, and 
educational resources (PRECISION program) into clinal practice during telehealth and in-
person visits. 
This study is descriptive and there will be no formal hypothesis testing for the primary 
objective. 
2.2 
Secondary Objectives 
The secondary objectives of this study are: 
1. 
and 
Checklist, and educational resources (PRECISION program) are utilized as part of a 
telehealth or in-person visit with their HCP; 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
18 
2. To explore change in 
-up visit(s) (when 
available). 
2.3 
Exploratory Objectives  
The following are exploratory objectives: 
 
 
 
 
 
 
 
   
 
 
CCI
CCI
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
19 
3. 
METHODOLOGY 
3.1 
Study Design  General Aspects 
The purpose of this community program intervention study is to examine the process of 
 (PRECISION program) 
into clinical practice using either in-
treatment and asthma work-up and management, will be assessed. The duration of enrollment 
is nine months for each site (implementation stage), with an additional 3 months of follow-up 
to assess the sustainability of using the PRECISION program in clinical practice. The nine-
month implementation stage allows for the recruitment of approximately 50 patients per site 
for an initial visit, plus the potential for follow-up visits during the study. The three-month 
sustainability stage will allow for sites to continue to implement the PRECISION program in 
their clinical practice and for sites to describe any continued benefits of implementing the 
PRECISION program at their site. 
Approximately fifteen (15) to twenty (20) clinical sites will be recruited to participate in this 
study, categorized into the following four practice clusters: (1) primary care site (e.g., private 
practice, FQHC; (2) specialty care site (pulmonary, asthma/immunology); and (3) novel sites 
(e.g., pharmacy, nurse practitioners, nurse educators, prescribers and non-prescribers, 
telehealth component of Allergy and Asthma Network, pharmacy).  While all sites will be 
able to conduct both in-person and telehealth visits, sites will aim to conduct approximately 
25% of their initial patient visit using a telehealth platform (at a minimum). Both platforms 
(in-person and telehealth) can be used for the follow-up visit(s) for all clusters.  Each site will 
recruit a target of approximately 50 patients per site, with a total sample size of approximately 
750 to 1,500 patients. All patient completed materials will be available in English and 
Spanish. 
Additionally, Evidera will host a 30-minute conference call with each clinical site for up to 
four (4) time points (touchpoints) to discuss the implementation of PRECISION tools (i.e., 
frequency of visits to and the number of PDF views from study website), assess whether sites 
are meeting their targets for using the telehealth platform, address site questions, and discuss 
any challenges of implementing the PRECISION program. These meetings will take place at 
Months 1, 2, 3 (optional), and 6 and will also be used to identify any sites that may benefit 
from participating in a re-training session. The optional Month 3 touchpoint will be based on 
whether the site is having any difficulties with the study. After the 9-month implementation 
stage is complete, each site will be followed for another 3 months (maintenance stage). 
After verbally consenting patients (or parent/guardian when applicable) and documenting 
consent in the Patient Verbal Informed Consent Script, a staff member at the participating 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
20 
clinical sites will administer the AIRQ
 to patients >13 years old with an HCP-confirmed 
asthma diagnosis who are presenting to the clinic (via telehealth or in-person). After 
completing the AIRQ
, patients will be asked if they would be willing to complete an 
additional survey, sent as an electronic link via email, following the initial visit. For those 
participants who agree, clinical staff will 
database so that an electronic survey link from YouGov will be emailed to the patient within 
48 hours after the initial visit.  This survey includes the following questionnaires: 
, the ACE Questionnaire, 
, and the Patient Sociodemographics 
Questionnaire. Up to two (2) reminder e-mails will be sent to participants who have yet to 
complete the survey within approximately one week (7 days) of receiving the initial survey 
link e-mail.  
During the clinic visit (telehealth or in-person), HCPs will assess 
the 
AIRQ
 questions and discuss the results with the patient, use the full Asthma Checklist (as 
appropriate per HCP judgment), and access the educational resources (PRECISION program) 
either at the point of care or after the visit to guide assessments, adjustments, and follow-up 
for reviewing responses to patient education and management interventions. If a follow-up 
visit is conducted, the clinical site will administer the AIRQ
 3-month recall version. 
Sites/HCPs will complete a Clinical Case Report Form (CRF) after the initial visit and after 
the follow-up visit (if conducted) for each participant.  It should be noted that for all visits 
(initial and baseline), HCPs will be required to review the Assess component of the Asthma 
Checklist and provide their responses on the CRF; the Adjust and Review components of the 
Asthma Checklist will be available on the study website as well, but will not be mandatory to 
complete, 
 
The study team originally planned to collect exacerbation data to compare 12 months pre-
initial visit to 12 months post-initial visit among patients from third-party payer sites. 
However, these sites were unable to participate in the study. Therefore, high performing sites 
were selected to recontact their participants to ask if they would be willing to participate in a 
chart review to be conducted 12 months after their initial study visit. If patients agree, sites 
will use a new verbal consent script specific for the 12-month post-initial visit exacerbation 
data. For patients who consent, the site will complete a 12-month post-initial visit 
exacerbation CRF form. Data will only be collected for patients who provide their verbal 
consent. Verbal consent will be documented on the 12-month post-initial visit exacerbation 
CRF form.  
Evidera will host a 30-minute conference call with each clinical site for up to four-time points 
(touchpoints) to discuss the use of PRECISION tools, assess the mix of telehealth and in-
person visits, address site questions, and discuss a set of questions that focus on the challenges 
and efficiencies of using the PRECISION program. These meetings will take place at Months 
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
21 
1, 2, 3 (optional), and 6 and will also be used to identify any sites that may benefit from 
participating in a re-training session. The optional Month 3 touchpoint will be based on 
whether the site is having any difficulties with the study. After the 9-month implementation 
stage is complete, each site will be followed for another three months (maintenance stage). 
After patient enrollment and follow-up visits have been completed, prescribing providers at 
clinical sites (or the asthma coaches from the novel cluster of the Asthma and Allergy 
Network, or Non-prescribers, or nurse case-managers) will self-complete the Post-study 
Survey. The focus of this questionnaire will be to obtain feedback on the implementation of 
the AIRQ
, Asthma Checklist, and educational resources (PRECISION program) as part of 
their clinical practice (telehealth platform and in-person). 
Finally, the principal investigator from each site and key site staff (up to three staff members 
per site) will participate in a qualitative interview to gain a full understanding of the processes 
and issues related to implementing the AIRQ
, Asthma Checklist and educational resources 
(PRECISION program) as part of their clinical practice (telehealth and in-person visits). 
Additionally, the interviews will explore the best practices that may have been unique to their 
site, as well as plans for continuing the use of the AIRQ
 and PRECISION tools. The 
telephone interviews will be conducted approximately 9 to12 months from study 
implementation for each site and will last up to 60 minutes; all interviews will be audio-
recorded and transcribed. 
3.1.1 
Data Source(s) 
Approximately fifteen (15) to twenty (20) clinical sites will be selected to implement the 
 educational resources (PRECISION program) into 
clinical practice using telehealth and in-person platforms. The sites will be selected based on 
part of their care practice, the number of asthma patients visiting the clinic via telehealth per 
week, the diversity of the asthma patients treated by the clinic, the ability of the site to 
complete the study tasks in the allotted timeframe, and the anticipated unique component(s) 
used to contribute to the implementation process by the study site. Each site will be 
responsible for recruiting approximately 50 asthma patients per site. 
3.2 
Study Population 
Clinic staff will invite patients >13 years old with an HCP-confirmed asthma diagnosis who 
are presenting for a telehealth or in-person visit to complete the AIRQ
. Each site will aim to 
recruit approximately 50 patients, with a total sample size of 750 to 1,500 patients. 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
22 
3.3 
Inclusion Criteria 
Patients must meet all of the following criteria to be eligible for enrollment: 
1. > 13 years of age at the time of enrollment 
2. Diagnosis of HCP-confirmed asthma 
3. Able to read, understand and speak English or Spanish sufficiently self-complete or be 
administered the AIRQ
 via telephone, desktop, or mobile device (e.g., smartphone, 
iPad) 
4. Provide consent (adults/parents/guardians) and assent (age 13-17 years) to participate 
in the study. 
3.4 
Exclusion Criteria 
Patients meeting any of the following criteria will not be included in the study: 
1. Current diagnosis of active COPD or any lower respiratory diagnosis other than 
asthma 
2. Has a cognitive impairment, hearing difficulty, acute psychopathology, medical 
condition, or insufficient knowledge of the English or Spanish language that, in the 
opinion of the investigator, would interfere with his or her ability to agree to 
participate and/or complete the AIRQTM or other study questionnaires 
4. 
VARIABLES AND EPIDEMIOLOGICAL MEASUREMENTS 
4.1 
Exposures 
4.1.1 
Patient Verbal Informed Consent Scripts 
Verbal Informed Consent scripts for participan
, available in English and 
Spanish (Appendix A and Appendix B) and Verbal Informed Consent/Assent scripts for 
participants  <18 years old, available in English and Spanish (Appendix C and Appendix D) 
will be used to introduce the study before the 
(during the appointment reminder 
call) or during the visit (telehealth platform; in-person) to provide more information about the 
study and to document verbal consent and verbal assent in minors. 
4.1.2 
 
Appendix E) consists of 10 yes/no items, with the total score used to identify 
 questions address medication use, 
asthma symptoms, exacerbations, unscheduled medical telehealth visits, hospitalizations, and 
asthma-
-week recall period 
(questions 1 through 7), while the risk items use a recall period of the prior 12 months. The 
English and Spanish (Appendix F); both versions will be used in this 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
23 
study. The 
-month recall version in English (Appendix G) and 
Spanish (Appendix H). 
Sites will be asked to ensure that the AIRQTM is completed before the patient sees the HCP.  
For in-person visits, the AIRQTM can be completed by the patients on paper (self-
administration) or completed by site staff as interviewer-administered. For telehealth visits, 
the AIRQTM can be sent to patients in advance of the visit (e.g., sent via email as a PDF or 
sent via a link to www.digitalairq.com) and completed by the patients on paper (self-
administration) or completed by site staff as interviewer-administered. In the case that the 
patient receives the AIRQTM in advance of their visit, the patient can provide their responses 
on the self-completed AIRQTM to the site staff who will then transpose patient responses to the 
CRF paper version of the AIRQTM and provide to the HCP at the start of the visit.  Examples 
of ways to administer the AIRQTM during a telehealth visit will be provided as part of the site 
training. 
4.1.3 
Clinical Case Report Form 
For each participant, the clinical site will complete a Clinical CRF (Appendix I) during the 
initial site telehealth visit. The Clinical CRF serves to characterize patients based on their 
asthma history, current medications, time since most recent spirometry, the HCP
ing of 
, 12-month history of chart-reported exacerbations 
(when available), Assess component of the Asthma Checklist, and a treatment plan based on 
AIRQ
 score at the baseline telehealth visit (step-up/step down/no change). 
4.1.4 
Follow-up Clinical Clinical Case Report Form (CRF) 
A FOLLOW-UP CLINICAL CRF WILL BE COMPLETED FOR THOSE PATIENTS WITH A FOLLOW-UP VISIT 
(TELEHEALTH; IN-PERSON) DURING THE FOLLOW-UP PERIOD 
THE PATIENT
CHART-
REPORTED EXACERBATIONS (WHEN AVAILABLE), ASSESS 
COMPONENT OF THE ASTHMA CHECKLIST, AND A TREATMENT 
3-MONTH RECALL SCORE AT FOLLOW-
UP VISIT (E.G., STEP-UP/STEP DOWN/NO CHANGE, REFERRAL) ( 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
24 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
25 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
26 
 
Appendix J). 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
27 
4.1.5 
12-Month Post-Initial Visit Exacerbation Clinical Case Report Form (CRF) 
For each consented participant from the sites selected for the pre/post exacerbation data 
comparison, the site will complete a follow-up clinical case report form that includes chart-
reported exacerbations 12-months after the initial study visit (Appendix J).  
4.1.6 
Study Website 
Sites will have access to the study website 
 which 
includes the Asthma Checklist and PRECISION Educational Resources ( 
12-Month Post-Initial Visit Exacerbation Clinical Case Report Form 
Participant ID: ___ - ____ 
Verbal Consent Provided: 
 Yes 
 No 
Date verbal consent provided: MM/DD/YYYY 
Date form completed:  MM/DD/YYYY 
Please indicate the asthma exacerbation history since the patients initial study visit (12 months ago): 
PPD

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
28 
 
 
Investigator/Coordinator Signature: _________________________________ 
Appendix K). 
4.1.7 
Asthma Checklist 
The Asthma Checklist (see provider-facing tools in  
12-Month Post-Initial Visit Exacerbation Clinical Case Report Form 
Participant ID: ___ - ____ 
Verbal Consent Provided: 
 Yes 
 No 
Date verbal consent provided: MM/DD/YYYY 
Date form completed:  MM/DD/YYYY 
Please indicate the asthma exacerbation history since the patients initial study visit (12 months ago): 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
29 
 
 
Investigator/Coordinator Signature: _________________________________ 
APPENDIX K) IS BASED ON GINA AND THE NATIONAL ASTHMA 
EDUCATION AND PREVENTION PROGRAM (NAEPP) GUIDELINES. 
THIS THREE-PAGE TOOL IS DESIGNED TO ASSIST PROVIDERS 
WITH RECOGNITION, EVALUATION, AND OPTIMIZATION OF ALL 
PATIENTS WITH ASTHMA, THOSE WHO MAY BE UNCONTROLLED, AND THOSE WITH SEVERE ASTHMA 
(UNTREATED, DIFFICULT TO TREAT, REFRACTORY). PROVIDERS 
WILL BE ASKED TO COMPLETE THE ASSESS COMPONENT OF 
THE ASTHMA CHECKLIST AS PART OF THE CLINICAL CRF 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
30 
(APPENDIX I) FOR ALL BASELINE STUDY VISITS AND AS PART OF 
THE FOLLOW-UP CLINICAL CRF ( 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
31 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
32 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
33 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
34 
Appendix J) to support the assessment of their patient, but to the degree, they feel is most 
appropriate for the particular patient and particular circumstances of the visit. The Adjust and 
Review Responses component of the Asthma Checklist (pages 2 and 3) will be recommended 
for review by HCP but remain optional. 
4.1.8 
PRECISION Educational Resources 
Providers will have access to the study webpage which will contain the provider-facing 
materials and the patient-facing education resources included in the PRECISION program ( 
12-Month Post-Initial Visit Exacerbation Clinical Case Report Form 
Participant ID: ___ - ____ 
Verbal Consent Provided: 
 Yes 
 No 
Date verbal consent provided: MM/DD/YYYY 
Date form completed:  MM/DD/YYYY 
Please indicate the asthma exacerbation history since the patients initial study visit (12 months ago): 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
35 
 
 
Investigator/Coordinator Signature: _________________________________ 
Appendix K).  All resources can be accessed as desired either during patient visits or as 
resources before/after visits.  Resources may be downloaded as desired and used during 
patient visits and patient-facing materials can also be sent electronically to patients per the 
discretion of the HCP. 
4.1.9 
Asthma Clinic Experience (ACE) Questionnaire 
The ACE Questionnaire (Appendix L) is a self-administered electronic questionnaire that 
includes nine questions using a four-point Likert scale (strongly agree, agree, disagree, 
strongly disagree). Patients who agree will be sent this questionnaire via an e-mailed survey 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
36 
as part of their telehealth visit may have affected their experience when answering the 
questions. The ACE Questionnaire will be available in English and Spanish (Appendix M). 
4.1.12 
Patient Sociodemographics Questionnaire 
Sites will collect basic participant demographic information on the Clinical CRF
age, 
gender, and race. Participants who agree will be asked to complete additional demographic 
questions (Appendix R)
employment, and education, and will be used to describe the sample and assist with 
interpreting the results. Patients will be sent this questionnaire via an e-mailed web-link 
following their initial visit. The Patient Demographic Questionnaire will be available in 
English and Spanish (Appendix S). 
4.1.13 
Clinical Site Touchpoint Questions 
Evidera will conduct 30-minute conference calls with each clinical site for up to four (4) time 
points (touchpoints) to discuss the use of PRECISION tools, address site questions, and 
discuss a set of discussion questions that focus on the facilitators and barriers/challenges of 
implementing the PRECISION program (Appendix T). The same touchpoint implementation 
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
37 
questions will be asked to all clinical staff participating in each scheduled meeting: Months 1, 
2, 3 (optional), and 6. 
4.1.14 
Post-study Survey 
All HCPs who participated in at least 10 telehealth or in-person visits will be invited to 
complete the Post-study Survey (paper form) (Appendix U). The purpose of this survey is to 
obtain feedback on the implementation of the AIRQ
 
clinical practice 
(telehealth platform and in-person visit). 
4.1.15 
Semi-structured Interview Guide 
A semi-structured interview guide (Appendix V) will be used by the interviewer to obtain 
information from the principal investigator and key clinical site staff (up to three interviews 
per site) to gain a deeper understanding of the feasibility of implementing the AIRQ
 via 
telehealth and in-person, as well as sustainability of using the PRECISION program in their 
clinical practice. The semi-structured interview guide will include an introduction and specific 
questions/probes designed to facilitate discussion and optimize consistency across interviews. 
The interview guide will elicit from site personnel the process for implementing the AIRQ
, 
and recommendations for improving processes related to telehealth and in-person 
implementation. Also, any specific initiatives that were integrated into various practices will 
be discussed. Additional unscripted probes may also be used to gain further information or 
clarification. 
4.2 
Outcomes 
4.2.1 
Primary Outcome 
To address the primary objective of assessing the process and potential benefits when 
PRECISION program on a telehealth or in-person platform, the 
following outcomes will be assessed: 
 Post-study Telehealth Survey: Descriptive statistics (n, frequency, mean, and 
standard deviation [SD]) will be used to summarize the results from the Post-study 
Survey. 
 Qualitative Interviews: Results from the qualitative interviews will be summarized in 
tabular format, with key recommendations, advantages, and disadvantages grouped. 
Specifically, barriers, benefits, challenges, ease of implementation, and areas for 
improvement will be summarized. Also, the summary will capture if the PRECISION 
program has been utilized in clinical practice post-implementation, or what would 
need to be done to support the continued use of the PRECISION program in their 
clinical practice.  
 Implementation Touchpoint Discussion with Sites:  Key findings from the 
implementation questions discussed during the clinical site touchpoint meetings 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
38 
(including barriers and subsequent ways in which these barriers were addressed) will 
be summarized. 
4.2.2 
Secondary Outcome 
1. To address the secondary objective of assessing patient telehealth or in-person visit 
or in-person visit with 
their HCP, the following outcomes will be assessed: 
 
 ACE Questionnaire Responses: Descriptive statistics (n, frequency, mean, and SD) 
will be used to summarize by item for all nine items.  
 
2. To explore change in AIRQTM scores from initial visit to follow-up visits: 
 
 12M AIRQ
 (initial study visit) 
 3M AIRQ
 (follow-up visits) 
 
4.2.3 
Exploratory Outcomes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
39 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
40 
 
 
 
  
 
 
 
 
 
4.3 
Other Variables and Covariates 
Additional variables and covariates may be examined based on the availability of data. A 
more detailed description of additional variables and covariates will be included in the 
Statistical Analysis Plan. 
5. 
STATISTICAL ANALYSIS PLAN 
5.1 
Statistical Methods  General Aspects 
Descriptive statistics (n, frequency, mean, SD, median, range) will be used to characterize the 
sample in terms of sociodemographic and clinical characteristics and to summarize qualitative 
outcomes. These characteristics will be summarized for the sample overall, as well as for each 
site and cluster. 
Additional analyses, including various subgroup analyses, to aid in the interpretation of the 
defined outcome measures may also be conducted and will be described in the Statistical 
Analysis Plan. 
5.1.1 
Primary Objective(s): Assess the Process and Potential Benefit of 
Implementing the AIRQ
, Asthma Checklist, and Educational Resources 
(PRECISION program) into Clinical Practice during Telehealth and In-
Person Visits 
Descriptive statistics (n, frequency, mean, SD, and 95% confidence intervals [Cis]) will be 
and in-person platform. Qualitative inte
notes and the transcribed interviews. Findings from the touchpoint discussions with sites will 
be integrated into the qualitative findings. Audio recordings of interviews from clinical site 
personnel will be referred to as necessary to supplement interviewer notes and transcriptions. 
The interview results will be summarized in tabular format, with key recommendations, 
advantages, and disadvantages grouped accordingly. Specifically, barriers, benefits, 
challenges, ease of implementation, and areas for improvement will be summarized. Lastly, 
the results from the Post-study Survey will be summarized using descriptive statistics. 
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
41 
5.1.2 
Secondary Objective(s): To Assess Patient Visit Satisfaction When the 
Is Initiated as Part of a Telehealth or In-Person visit with Their 
HCP 
Questionnaire.  
Subgroup analysis may be conducted to examine responses by site, cluster, platform used, or 
AIRQTM score. 
-up 
-Month Recall when available) will be explored by site and 
cluster and presented using descriptive statistics (n, frequency, mean, and SD) and mean 
-up 
visits) and a shift analysis for control level. 
Change 
and control level between the initial telehealth visit AIRQTM (12-
Month Recall) and follow-
-Month Recall when available) will 
be stratified by site and cluster and presented using descriptive statistics (n, frequency, mean, 
and SD). M
 (95% CIs computed; initial visit vs. 
follow-up visits) and a shift analysis for control level will be conducted. 
5.1.3 
Exploratory Objective(s): 
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI
CCI
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
42 
 
 
 
 
All analyses will be detailed in a Statistical Analysis Plan.  Additional exploratory analyses 
may be performed to further examine specific aspects of available clinical data. 
5.2 
Bias 
5.2.1 
Methods to Minimize Bias 
Given that completing the ACE Questionnaire is optional, the potential for response bias (e.g., 
patients who like the telehealth platform may be more inclined to complete the survey) may be 
introduced into this study. This will be noted when interpreting the results. Additionally, 
patients who have a follow-up assessment may be more severe than those who do not; thus, 
change scores may not be representative of the entire sample, which will also be noted when 
interpreting results. 
5.2.2 
Adjustment for Multiple Comparisons 
Not applicable. 
5.2.3 
Strengths and Limitations 
The strengths of this study are that it aims to include a variety of clinical practice types, that 
the clinical sites have access to diverse patient populations, and the study will have a large 
sample size. The limitations of this study include that up to 20 clinical sites may not be 
generalizable to all clinical sites treating asthma patients across the US, and that the patient 
sample may not be generalizable to all asthma patients >13 years old across the US. 
5.3 
Sample Size and Power Calculations 
As the aim of this study is to assess the process and feasibility of implementing the AIRQ
 
using a telehealth platform, inferential statistics will not be conducted, and a formal sample 
size estimation is not applicable. Each site will target approximately 50 patients; however, 
some sites may be able to recruit more than 50 patients, resulting in a total sample size of 
approximately 750 to 1,500 patients. Further, each cluster (primary care, specialist, novel) will 
CCI
CCI

Observational Study Protocol
Study Code D2287L00028 [EVA-26645-03]
Version 2.0
Date June 16, 2022
Observational Study Protocol Form
Version 3.0
Form Doc ID: AZDoc0059948
Parent Doc ID: SOP LDMS_001_00164328
43
contain approximately 3 to 5 sites to have balanced sample sizes between the practice clusters. 
Implementing the AIRQ
, Asthma Checklist, and educational resources (PRECISION 
program) among approximately 50 patients will provide sites with enough experience to
provide feedback on the outcomes, barriers, benefits, challenges, ease of implementation, and 
areas for improvement for future integration as a telehealth and in-person platform.  
Additionally, an adequate sample should be available to confirm the performance of the 
in a diverse primary care cluster.
6.
STUDY CONDUCT AND REGULATORY DETAILS
6.1
Study Conduct
6.1.1
Study Flow Chart and Plan for Telehealth or In-Person Visits
Figure 1. Study Flow Overview of Initial Telehealth or In-Person Visit

Observational Study Protocol
Study Code D2287L00028 [EVA-26645-03]
Version 2.0
Date June 16, 2022
Observational Study Protocol Form
Version 3.0
Form Doc ID: AZDoc0059948
Parent Doc ID: SOP LDMS_001_00164328
44
Figure 2. Overview of the Follow-up Telehealth or In-person Visit Study Flow
Table 1. Study Plan
Study Procedure
Timing
Completed by:
Clinical Site 
(Staff/HCP)
Patient
Telephone Introduction to Study
At time of appointment reminder (if not 
automated)
X
Introduction to Study
At the initial visit (telehealth; in-person)
X
Document Consent/Assent
At the initial visit (telehealth; in-person)
X
Clinical CRF, which includes the 
Assess component of the Asthma 
Checklist (page 1)
At the initial visit (telehealth; in-person)
X
At the initial visit (telehealth; in-person)
X
ACE Questionnaire
Sent to patient within approx. 48 hours 
following initial visit via e-mail link (two
email reminders)
X
 
 
X
X
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
45 
Study Procedure 
Timing 
Completed by: 
Clinical Site 
(Staff/HCP) 
Patient
Patient Sociodemographics 
Questionnaire 
Sent to patient within approx. 48 hours 
following initial visit via e-mail link (two 
email reminders) 
 
X 
-month Recall 
Used at the follow-up visit (telehealth; in-
person), should a follow-up visit occur 
 
X 
Follow up Clinical CRF, which 
includes the Assess component of 
the Asthma Checklist(page 1)  
Used at the follow-up visit (telehealth; in-
person), should a follow-up visit occur 
X 
 
Clinical Site Touchpoint 
Questions 
Up to 4 meetings over the 6-month patient 
recruitment period 
X 
 
Post-study Survey 
After patient enrollment is nearly completed 
(approximately 30 telehealth visits) 
X 
 
Qualitative Interviews with Site 
Principal Investigator and Key 
Staff 
After patient enrollment is completed  
X 
 
12 Month Post-Initial Visit 
Exacerbation CRF 
Used to collect 12-month post-initial visit 
exacerbation data for patients at selected 
sites who consented 
X 
 
 
6.1.2 
Procedures 
Patients will be recruited from approximately 15 to 20 clinical sites in geographically diverse 
locations across the US. Clinical site staff will identify and verify the initial eligibility of 
potential participants through a review of patient records. Clinical sites may identify potential 
participants through daily telehealth visit schedules, chart/database/emergency medical record 
reviews, or recruit via advertisement (Asthma and Allergy Network only) (Appendix X). 
Clinical site staff and/or prescribing HCPs will ensure the completion (either self- or 
interviewer-administered) of the 
 3-month Recall when follow-up 
visits may occur during the study follow-up period of 6 months after enrollment, complete the 
assessment component of the Asthma Checklist, and implement educational resources 
(PRECISION program), as well as complete the Clinical CRF and the Follow-up Clinical 
CRF for all patients throughout the study. 
At the start of patient enrollment, Evidera will provide each clinical site with Participant 
Packets for all study participants. Each packet will be labeled with a unique participant 
identification (ID) number, and all forms included in the packet will have headers pre-
populated with the same unique participant ID number. The packet will include the Patient 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
46 
Verbal Informed Consent Script, which includes consent/assent documentation, the AIRQ
, 
the Clinical CRF, which includes the Assess component of the Asthma Checklist (page 1 
only), the AIRQ
 3-month Recall, and the Follow-up Clinical CRF, which includes the 
Assess component of the Asthma Checklist (page 1). Note that the Assess component of the 
Asthma Checklist is mandatory for this study, while the Adjust and Review Responses 
component of the Asthma Checklist (pages 2-3) will be used at the discretion of the HCP. The 
 3-month Recall and the Follow-up Clinical CRF will be paper clipped and printed on 
yellow paper to differentiate these two follow-up forms from the baseline forms that are 
completed during the initial visit. The patient will complete the AIRQ
 before seeing their 
HCP at the initial visit (telehealth or in-person), and the AIRQ
 3-month Recall before 
seeing their HCP at the follow-up visit (telehealth or in-person). Training will be provided to 
sites on options available for administering the AIRQTM (i.e., digital vs paper formats). 
Before or during the initial visit, a clinical site staff member will introduce the study to the 
patient using the Patient Verbal Informed Consent Script. The scripts provide an overview of 
the purpose and nature of the study and will be used to obtain verbal consent from the 
patient/guardian, as well as assent from those participants under the age of 18 years. For 
patients 18 years or older, the site will document that the patient provided verbal consent. For 
patients aged 13-17 years, the site will document that the parent/guardian has granted consent 
and that the patient has provided assent. The clinical site staff will document patient eligibility 
and interest using the Recruitment Tracking Log (Appendix Y), including documentation of 
the number of patients who choose not to participate or are ineligible. 
Once the patient has provided verbal consent/assent to the clinical site staff to participate in 
this study, and the clinical site staff has documented that the patient has provided 
consent/assent (Patient Verbal Informed Consent Screening Script), the clinical staff will 
ensure that the patient completes the AIRQ
 before seeing the HCP.  After the questionnaire 
has been completed, clinical staff will ask the participant if they would be willing to complete 
an additional brief survey following their visit and at 3-months. If participants agree to 
complete the additional survey, 
database at YouGov so that YouGov may send a survey link to the participant within 48 hours 
of enrollment (English Version: Appendix Z; Spanish Version: Appendix AA). The survey 
link will include the following questionnaires: the ACE Questionnaire, 
 
 
 and the Patient Sociodemographics Questionnaire. Participants will 
be asked to complete the survey within seven (7) days. Up to two email reminders will be sent 
to participants who have yet to complete the survey within approximately one week (7 days) 
of receiving the initial e-mail with the survey link (English Version: Appendix BB; Spanish 
Version: Appendix CC).  
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
47 
The clinical site will be responsible for completing a Clinical CRF, which also includes the 
assessment content of the Asthma Checklist (page 1), the AIRQ
, and the Follow-up Clinical 
CRF with each participant. All patient materials (e.g., questionnaires, resources) will be 
available in both English and Spanish. 
Upon completion of the AIRQ
, the clinical staff member will provide ALL materials in the 
enrollment packet to the HCP conducting the clinical visit (telehealth or in-person). The HCP 
will review the AIRQ
 results and total score during the clinic visit. If the HCP feels it is 
appropriate, he/she may discuss with the patient his/her responses to individual screener 
questions. The HCP will then use the AIRQ
 results in conjunction with the Asthma 
Checklist and education materials (PRECISION program) with the patient to guide the 
 Following the 
clinic visit (telehealth or in-person), the HCP and site staff will complete the Clinical CRF, 
which also includes responses to the Assess component of the Asthma Checklist and 
documentation of study eligibility and consent. 
If a follow-up patient clinic visit occurs after the initial visit, the site staff/HCP will be asked 
to ensure that the participant completes the AIRQ
 3-month Recall, using the same 
procedures as the initial telehealth visit. A Follow-up CRF form will also be completed during 
this visit.  Note that patients will not be asked to complete additional questionnaires at the 
follow-up visit. 
The study team originally planned to collect exacerbation data to compare 12 months pre-
initial visit to 12 months post-initial visit among patients from third-party payer sites. 
However, these sites were unable to participate in the study. Therefore, high performing sites 
were selected to recontact their participants to ask if they would be willing to participate in a 
chart review to be conducted 12 months after their initial study visit. If patients agree, sites 
will use a new verbal consent script specific for the 12-month post-initial visit exacerbation 
data. For patients who consent, the site will complete a 12-month post-initial visit 
exacerbation CRF form. Data will only be collected for patients who provide their verbal 
consent. Verbal consent will be documented on the 12-month post-initial visit exacerbation 
CRF form. This will be compared to the exacerbation data 12 months pre-initial visit, which 
was collected as part of the planned clinician-completed CRF form. Evidera will host a 30-
minute conference call with each clinical site for up to four (4) time points (touchpoints) at 
Months 1, 2, 3 (optional), and 6 to discuss the use of the PRECISION tools, address site 
questions, and discuss a set of touchpoint questions that focus on the challenges and 
facilitators of implementing the PRECISION program. These meetings will also be used to 
identify any sites that may benefit from participating in a re-training session (budget assumes 
up to six sites will need re-training). The optional month three (3) touchpoint will be based on 
whether the site is having any difficulties with the study. 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
48 
After patient enrollment has been completed, prescribing providers at clinical sites, nurse case 
managers, or the asthma coaches from the telehealth component of Asthma and Allergy 
Network who treated at least 10 patients will complete the Post-study Survey. Evidera will 
provide the participating HCP with Post-study Survey, via an email PDF attachment (to be 
self-completed by the HCP). The emailed survey will have a pre-populated header with a 
unique participant ID number. 
Approximately nine months following study implementation, Evidera will conduct telephone 
interviews with key staff and site principal investigators (up to three staff members per site). 
Interviews will follow a semi-structured interview guide to elicit from participating HCPs the 
advantages and disadvantages of implementing AIRQ
 in their clinic, their process for 
implementing these tools, what could be improved to facilitate implementation, and any 
unforeseen potential effects of implementing these tools. Interviews will be conducted via 
telephone and are expected to last approximately 60 minutes. Interviews will be audio-
recorded and transcribed. 
Patients will complete the following measures: 
 
 12M 
 
 3-Month Recall (as appropriate) 
 ACE Questionnaire (for those who agree; initial visit only) 
 Patient Sociodemographics Questionnaire (for those who agree; initial visit only) 
HCPs will complete the following measures: 
 Clinical CRF 
 Follow-up Clinical CRF (if appropriate) 
 Clinal Site Touchpoint Questions 
 Post-study Survey  
 Qualitative Interview  
 12-month Post-Initial Visit Exacerbation CRF (when applicable) 
6.1.3 
Quality Control 
6.1.3.1 
Responsibilities 
Evidera Responsibilities 
Clinical Site Responsibilities 
Website Host Responsibilities 
Contract directly with clinical 
sites 
Complete and return all 
institutional review board (IRB)-
required documentation to 
Evidera, as needed 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
49 
Evidera Responsibilities 
Clinical Site Responsibilities 
Website Host Responsibilities 
Develop and provide to sites all 
necessary IRB materials and 
forms for the patient screening 
process 
Participate in a 60-minute training 
session about the study, conducted 
by Evidera 
 
Submit IRB paperwork on behalf 
of the sites to the central IRB, or 
assist sites with local IRB 
submissions 
Ensure that appropriate training 
has been provided for all staff 
involved in the study 
 
Collect, monitor, and store data 
using DataFax
a direct fax-to-
computer (or PDF-to-computer) 
data management system 
Maintain patient confidentiality; 
the YouGov3 system on the day of 
recruitment 
 
Develop training materials for the 
training sessions for relevant site 
investigators and coordinators 
before study launch 
Recruit and screen patients using 
the Verbal Informed Consent and 
Recruitment Scripts provided, and 
obtain verbal consent/assent 
 
Continually monitor patient 
recruitment 
Track recruitment efforts in the 
Recruitment Training Log 
 
Remunerate sites 
Provide Evidera project staff with 
weekly updates on screening and 
recruitment progress 
 
Contact sites for data queries on 
completed or missing forms 
Ensure that all necessary 
questionnaires and forms are 
completed 
Host the study website which 
includes the Asthma checklist 
and educational materials, as 
well as maintain and track all 
views to the site (i.e., number of 
time the HCP clicks/PDF views 
the Asthma Checklist and 
educational resources) 
Lead study closeout procedures, 
with the help of clinical site staff 
(e.g., closing out the study with 
the IRB) 
Complete Clinical CRFs for all 
enrolled patients after interest has 
been obtained 
 
Statistical analyses 
Designate one staff member to be 
implementation, and provide 
telephone number 
 
Adverse event (AE) reporting of 
AstraZeneca products 
Promptly respond to data queries 
from Evidera 
 
 
Maintain appropriate and 
confidential project files 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
50 
Evidera Responsibilities 
Clinical Site Responsibilities 
Website Host Responsibilities 
 
Adhere to all site-related 
procedures outlined in the protocol 
 
 
Perform required study closeout 
procedures 
 
 
AE reporting (as outlined in 
section 6.3)  
 
 
Monitoring 
Before the first subject is recruited into the study, Evidera will perform the following 
activities: 
 
 
 Discuss with the investigator(s) (and other personnel involved in the study) their 
responsibilities with regards to protocol compliance, and the responsibilities of 
AstraZeneca or its representatives; this will be documented in a Study Primary 
Agreement or equivalent between AstraZeneca/delegate and the investigator. 
Evidera can implement different activities to ensure compliance with AstraZeneca standards 
of quality. These activities could include but are not limited to: 
Contact the sites to: 
 Provide information and support to the investigator(s) 
 Confirm that the research team is complying with the protocol, and that data are being 
accurately recorded in the CRFs 
 Ensure that the consent/assent documentation portion of the eligibility section of the 
Clinical CRF are signed, and screening scripts 
 
 Ensure that the CRFs are completed properly and with adequate quality 
Monitor activities for: 
 Ensuring that consent/assent is documented in Patient Verbal Informed Consent Script 
and the Clinical CRF 
 Evidera will host a 30-minute conference call with each clinical site for up to four (4) 
time points (touchpoints) at Months 1, 2, 3 (optional), and 6 to address site questions, 
and discuss a set of touchpoint questions that focus on the challenges and facilitators 
of implementing the PRECISION Tools. 
Training of Study Site Personnel 
The principal investigator will ensure that appropriate training relevant to the study is given to 
investigational staff and that any new information relevant to the performance of this study is 
forwarded to the staff involved. 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
51 
6.1.3.2 
ePRO Programming and Hosting 
A Health Insurance Portability and Accountability Act (HIPAA)-compliant vendor 
specializing in electronic data capture will be responsible for the programming and hosting of 
the electronic patient-reported outcome (ePRO) data management system to collect and 
monitor data captured by the patient questionnaires. The quality assurance process will 
include extensive end-to-end testing, as well as a pre-test of data export and tabulations before 
launching with a live sample. During data collection, the web survey responses will be tracked 
by unique participant identifiers
not participant names. 
Quantitative data from the clinical CRF will be transmitted via a secure SharePoint site 
directly into the electronic system database, DataFax. Data discrepancies will be identified 
and resolved. 
6.1.3.3 
DataFax CRF and Database Setup 
The AIRQ
, the AIRQ
 3-month Recall, Clinical CRF (which includes eligibility and 
consent documentation and the Asthma Checklist Assess content), the Follow-up Clinical 
CRF, and the Post-study Survey will be collected and managed using the DataFax system, 
 Before data collection, data 
verification guidelines regarding out-of-range values, inconsistent responses, and data checks 
will be developed; and a testing of the DataFax system will be conducted. 
CRF data will be optically entered into the study database upon transmittal via DataFax; once 
received, each CRF will be processed and reviewed by two trained project team members. The 
first-level reviewer will review all CRFs, while the second-level reviewer will review any 
items the first-level reviewer flagged or queried. Discrepancies or queries that are not resolved 
by the data entry staff will be forwarded to the sites for resolution. 
6.1.3.4 
Database Management 
A database for all quantitative data collected in the interviews from the paper-completed 
questionnaires (e.g., AIRQ
, Clinical CRF) will be developed, tested, and validated using 
DataFax software. DataFax is a direct fax-to-computer (or PDF-to-computer) data 
management system that uses optical character recognition (OCR) software for collecting 
study CRFs that are sent directly into the system. DataFax is a Food and Drug Administration 
(FDA) Title 21 Code of Federal Regulations (CFR) Part 11 Compliant system that provides a 
time-stamped electronic audit trail for the creation, modification, or deletion of electronic 
data, and is required for studies seeking FDA regulatory submission. 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
52 
6.2 
Protection of Human Subjects 
This community program intervention study will be performed following ethical principles 
that are consistent with the Declaration of Helsinki, International Council for Harmonisation 
(ICH), Good Clinical Practices (GCPs), and the applicable legislation on non-interventional 
and/or community program interventional studies. 
The investigator will perform the community program intervention study in accordance with 
the regulations and guidelines governing medical practice and ethics in the 
country, 
and in accordance with currently acceptable techniques and know-how. 
The final community program intervention study protocol, including the final version of the 
subject Informed Consent Form, must be approved or given a favorable opinion in writing by 
the ethics committee/institutional review board (IRB)/independent ethics committee (IEC). 
The ethics committee/IRB/IEC must also approve any amendment to the protocol and all 
advertising used to recruit subjects for the study, according to local regulations. 
6.2.1 
Patient Informed Consent 
Clinical site staff will be responsible for ensuring that each participant is given full and 
adequate oral information about the 
Participants will also be notified that they are free to withdraw from the study at any time. 
Participants will also be informed that, should they choose not to participate in all or any part 
of the study, their current or future treatment at the site will not be affected. Participants will 
be given the opportunity to ask questions and allowed time to consider the information 
provided. Participants will be required to provide verbal consent/assent to participate in the 
study. Clinical site staff will be responsible for documenting patient consent/assent by 
initialing and dating the patient verbal informed consent/assent. Script, documenting 
eligibility and consent in the Clinical CRF, and acknowledging that the patient agreed to 
participate in the study. 
The p
consent (adults or parent/guardians) and verbal assent from minors 
must be obtained and documented before any specific procedures for this implementation 
study are performed, including: 
 Administering the AIRQTM 
 Obtaining email address for follow-up questionnaires  
 Completing the Clinical CRFs 
The Investigator must store the original Patient Verbal Informed Consent script documenting 
verbal consent/assent in a secure locked location. 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
53 
This study involves participant-completed measures for information purposes only; the study 
does not involve the use of an investigational drug or device. There are no known risks or 
benefits to participants. During or following the research study, patients may become more 
aware of how they feel about their condition
and how their condition may affect certain 
aspects of their lives. Patients will be encouraged to talk with their asthma provider about their 
questions or concerns. The elements of federal regulations about consent procedures, 
disclosure of potential risks and benefits, and patient confidentiality will be strictly observed. 
6.2.2 
Health Care Practioner and Key Clinical Site Staff Informed Consent 
Health care practitioners (HCPs) (e.g., doctor, specialist, nurse practitioner, pharmacist, 
asthma educator, care coordinator, physician assistant) and key clinical site staff (e.g., site 
coordinator) will be provided full and adequate written information before consenting to 
participate in the Post-study Survey and full and adequate oral information before 
participating in the semi-structured interviews about the nature, purpose, procedures, risks, 
and benefits of the survey and interview. HCPs/key clinical site staff participants will also be 
notified that they are free to withdraw from participating in the survey or interview at any 
time. Participants will also be informed that, should they choose not to participate in all or any 
part of the survey or interview, their current or future employment at the site will not be 
affected. HCPs/key clinical site staff participants will be given an opportunity to ask questions 
and given time to consider the information provided. Before completing the Post-study 
Survey, HCPs will consent to participate in the study by ticking a box that indicates that, by 
completing and returning the form, they are voluntarily agreeing to take part in the survey. 
HCPs/key clinical site staff participating in the semi-structured interviews will be required to 
provide verbal consent to participate in the interview. Research staff will be responsible for 
documenting the HCP and 
HCP/
script.  
The Researchers must store the original HCP/key clinical site staff Written (for Post-study 
Surveys) and Verbal Informed Consent (for qualitative interviews) scripts documenting 
consent in a secure locked location. 
6.2.3 
Confidentiality of Study/Participant Data 
All data collected will be strictly confidential, in accordance with local, state, and federal law. 
Personnel from the following organizations may examine the research study records: Evidera, 
AstraZeneca and its affiliates, and regulatory agencies (such as the FDA and the IRB). Only 
clinical site study staff involved in participant recruitment, clinical data extraction, and 
questionnaire administration will know the identities of patients. Staff will be instructed to 
maintain complete confidentiality of all collected data. Participant data files collected by 
clinical sites and shared with either Evidera or AstraZeneca will be kept in a locked file 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
54 
cabinet separate from their identifying information and will be destroyed per Evider
after a period of 15 years. The summary report generated from the completed questionnaires 
will not contain any participant-identifying information. Medical data collected will not be 
associated with personal health identification data. All study data will be de-identified. 
Evidera retains records for a minimum of two years on-site, and an additional five years off-
site. Upon enrollment, participants will be assigned unique ID numbers, which will be used to 
track participants throughout the study. Only the unique participant ID numbers and 
participant initials will be entered into the database and recorded on the participant 
questionnaires
not participant names. 
This descriptive study will be performed in accordance with ethical principles that are 
consistent with the Declaration of Helsinki, ICH, GCP, and the applicable legislation on 
community program intervention studies. 
The investigators will perform this descriptive study in accordance with the regulations and 
guidelines governing medical practice and ethics in the descriptive study
, and in 
accordance with currently acceptable techniques and know-how. 
The final descriptive study protocol must be approved or given a favorable opinion in writing 
by the ethics committee/IRB/IEC. 
The ethics committee/IRB/IEC must also approve any protocol amendment and all advertising 
used to recruit subjects for the study, according to local regulations. 
6.3 
Collection and Reporting of Adverse Events/Adverse Drug 
Reactions 
This is a community program intervention study, with no requirements to actively collect AEs 
during the study, since study enrollment is based on disease diagnosis and does not require the 
administration of an AZ drug. However, if an investigator (or patient) would like to report an 
AE that is not required to be collected, this can be reported as a spontaneous report according 
to local regulations and procedures. 
It is also not required to report potential AEs based on answers to the following patient-
, 
-month Recall
and ACE
. 
The rationale is: 
a. The signs and symptoms collected by these instruments are prevalent among asthmatic 
patients. It is not feasible to evaluate associations between a specific drug and events 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
55 
reported by patients based on these instruments, due to a lack of baseline disease 
information and a temporal relationship of drug and event. 
Patients will be informed that their healthcare providers (including clinic study staff and their 
clinicians) may not be reviewing their responses to the study questionnaires in real-time. They 
will be instructed to report any health concerns or issues that they may experience directly to 
their healthcare providers.  
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
56 
7. 
LIST OF REFERENCES 
Expert Panel Working Group of the National Heart Lung Blood Institute, et al. 2020 Focused 
Updates to the Asthma Management Guidelines: A Report from the National Asthma 
Education and Prevention Program Coordinating Committee Expert Panel Working Group. J 
Allergy Clin Immunol. 2020;146(6):1217-1270. 
 
. 
 
 
 
Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe asthma 
phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma Research 
Program. J Allergy Clin Immun. 2007;119(2):405-413. 
Murphy KR, Chipps B, Beuther DA, et al. Development of the Asthma Impairment and Risk 
Questionnaire (AIRQ): A Composite Control Measure. J Allergy Clin Immunol Pract. 
2020;8(7):2263-2274 e2265. 
 
 
National Asthma Education, Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines 
for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin 
Immunol. 2007;120(5 Suppl):S94-138. 
Nunes C, Pereira AM, Morais-Almeida M. Asthma costs, and social impact. Asthma Res 
Pract. 2017;3:1. 
 
 
 
 
 
CCI
CCI
CCI
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
57 
APPENDIX A. PATIENT VERBAL INFORMED CONSENT SCRIPTS 
 (ENGLISH VERSION) 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
58 
APPENDIX B. PATIENT VERBAL INFORMED CONSENT SCRIPTS 
 
Placeholder 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
59 
APPENDIX C. PATIENT VERBAL INFORMED ASSENT/CONSENT 
SCRIPTS (FOR < 18 YEARS) (ENGLISH VERSION) 
APPENDIX D. PATIENT VERBAL INFORMED CONSENT SCRIPTS 
(FOR < 18 YEARS) (SPANISH VERSION) 
Placeholder 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
60 
APPENDIX E
 (ENGLISH VERSION) 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
61 
APPENDIX F
 (SPANISH VERSION) 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
62 
APPENDIX G
-MONTH RECALL (ENGLISH VERSION) 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
63 
APPENDIX H
-MONTH RECALL (SPANISH VERSION) 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
64 
APPENDIX I. CLINICAL CASE REPORT FORM (CRF) 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
65 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
66 
  
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
67 
 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
68 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
69 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
70 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
71 
APPENDIX J. FOLLOW-UP CRFS  
Follow-up Clinical Case Report Form 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
72 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
73 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
74 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
75 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
76 
12-Month Post-Initial Visit Exacerbation Clinical Case Report Form 
Participant ID: ___ - ____ 
Verbal Consent Provided: 
 Yes 
 No 
Date verbal consent provided: MM/DD/YYYY 
Date form completed:  MM/DD/YYYY 
Please indicate the asthma exacerbation history since the patients initial study visit (12 months ago): 
 
 
Investigator/Coordinator Signature: _________________________________ 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
77 
APPENDIX K. PRECISION SUPPLEMENTAL ONLINE 
EDUCATIONAL RESOURCES 
Patient Facing Tools 
AIRQTM: Asthma Control and You (English Version) 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
78 
AIRQTM: Asthma Control and You (Spanish Version) 
 

Observational Study Protocol
Study Code D2287L00028 [EVA-26645-03]
Version 2.0
Date June 16, 2022
Observational Study Protocol Form
Version 3.0
Form Doc ID: AZDoc0059948
Parent Doc ID: SOP LDMS_001_00164328
79
Study Participant Education Printable Materials 
Asthma and Other Health Conditions (English Version)
Asthma and Spirometry Testing (English Version)
Understanding Airway Inflammation in Asthma (English Version)
Asthma and Other Health Conditions (Spanish Version)
Placeholder
Asthma and Spirometry Testing (Spanish Version)
Placeholder
Understanding Airway Inflammation in Asthma (Spanish Version)
Placeholder
Patient Animations
Placeholder for all Animations, English, and Spanish
Asthma and Other Health Conditions (PDF Storyboard document )
Asthma and Spirometry Testing (PDF Storyboard document )
Understanding Airway Inflammation in Asthma (PDF Storyboard document )
Using Your Pressurized Metered-Dose Inhaler (pMDI) (PDF Storyboard document and 
animation)
Using Your Pressurized Metered-Dose Inhaler (pMDI) With Spacer (PDF Storyboard 
document and animation)

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
80 
Provider Facing Tools 
Asthma Checklist - Intended Use Document  
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
81 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
82 
Asthma Checklist 
Page 1: Assess  
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
83 
Page 2. Adjust 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
84 
Page 3. Review Response 
 
 
 

Observational Study Protocol
Study Code D2287L00028 [EVA-26645-03]
Version 2.0
Date June 16, 2022
Observational Study Protocol Form
Version 3.0
Form Doc ID: AZDoc0059948
Parent Doc ID: SOP LDMS_001_00164328
85
Quick Reference for Point Care Use
Selections from the US Guidelines and Global Report on Asthma
Using an Asthma Action Plan
In-Depth Information for Self-directed Review 
Asthma Phenotypes and Endotypes
Diagnosing Comorbidities Associated with Asthma
Inhaler Selection and Technique Training
Systematic Approach to Spirometry

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
86 
APPENDIX L. ASTHMA CLINIC EXPERIENCE (ACE) 
QUESTIONNAIRE (ENGLISH VERSION) 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
87 
APPENDIX M. ASTHMA CLINIC EXPERIENCE QUESTIONNAIRE 
(SPANISH VERSION) 
 
 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
88 
 
 
 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
89 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
90 
 
 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
91 
Placeholder 
 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
92 
APPENDIX R. PATIENT SOCIODEMOGRAPHICS QUESTIONNAIRE 
(ENGLISH VERSION) 
Please complete all questions, if possible.  
1. What is your age? _____ years 
 
2. What is your sex?  
 male   
 female    
 non-binary    
 Other:______ 
 
3. What is your ethnic background?  
  Hispanic or Latino  
  Not Hispanic or Latino  
 
4. 
 
  White 
  Black or African American  
  Asian  
  Native Hawaiian or other Pacific Islander  
  American Indian or Alaska Native  
  Other (specify): ____________________________________ 
 
5. 
 
  Living alone 
  Living with a spouse, partner, family, or friends  
  Other (specify): _____________________________ 
 
6. How would you describe your employment status? (Please mark only one box with an 
 
  Employed, full-time 
  Employed, part-time 
  Homemaker 
  Student 
  Unemployed 
  Retired 
  Disabled 
  Other (specify): _________________________________________________ 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
93 
7. What is the highest level of education you have completed? (Please mark only one box 
 
  Less than high school 
  Secondary/high school 
  Associate degree, technical or trade school 
  College/university degree  
  Postgraduate school  
  Other (specify): _________________________________________________ 
 
8. 
 
  Less than $15,000 
  $15,000 to $29,999 
  $30,000 to $44,999 
  $45,000 to $59,999 
  $60,00 to $74,999 
  $75,000 to $99,999 
  $100,000 or more 
  Prefer not to answer 
 
9. How old were you when you were diagnosed with asthma? _____   
10. Do you smoke? 
  Yes, current smoker  
  Not currently, but previous smoker  
  No, never smoked 
 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
94 
APPENDIX S. PATIENT SOCIODEMOGRAPHICS QUESTIONNAIRE 
(SPANISH VERSION) 
Placeholder 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
95 
APPENDIX T. CLINICAL SITE TOUCH POINT QUESTIONS 
1. Please describe how the PRECISION Program is being implemented at your site? 
2. What aspects of study implementation are going well for your site?  Telehealth vs in-
person? 
3. What aspects of study implementation have been challenging for your site? Has the 
site experienced any barriers to implementing the PRECISION program? Telehealth vs 
in-person? 
4. Please describe any site-level factors (e.g., site operations, clinical team) that have 
affected the implementation of the PRECISION Program on a telehealth platform at 
your site? During an in-person visit? 
5. What could be done to help overcome these site-level challenges and support the use 
of the PRECISION Program on a telehealth platform at your site? During an in-person 
visit? 
6. Please describe any participant-level factors that have affected the implementation of 
the PRECISION Program on a telehealth platform at your site? During an in-person 
visit? 
7. Based on your experiences to date, does your site plan to make any changes or adapt 
how the PRECISION Program is currently being implemented on a telehealth platform 
at your site? During an in-person visit? 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
96 
APPENDIX U. POST-STUDY SURVEY 
PART 1. INFORMED CONSENT 
PART 2. POST-STUDY SURVEY 
1. Approximately how many patients have you treated using the PRECISION Program?  
______  
2. Which visit type best describes how the majority of your initial patient visits took place? 
  Telehealth visit (approximately __ %) 
  In-person visit (approximately __ %) 
 
3. How would you rate the overall ease of implementing the AIRQ   into your clinical 
practice using the telehealth platform? 
  Very easy 
  Somewhat easy 
  Difficult 
  Very Difficult 
 
4. How would you rate the overall ease of implementing the AIRQ   into your clinical 
practice during an in-person visit? 
  Very easy 
  Somewhat easy 
  Difficult 
  Very Difficult 
 
5. Did the AIRQ  help you manage your patients? 
  Yes, very much 
  Yes, somewhat 
  Not at all 
 
6. Regardless of intermittent or persistent, on average, what percentage of your asthma 
patients would you classify as: 
___ % Mild asthma 
___% Moderate asthma 
___% Severe asthma  
= 100% 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
97 
7. 
s (e.g., 
hospitalizations, exacerbations, medication side effects) from their asthma that you would 
have otherwise missed? 
  Yes 
  No 
 
8. What did you find most 
? 
  
 
  Questions on impact/impairment (#1-6) 
  Question on control (#7) 
  Questions on exacerbations and healthcare resource utilization (#8-10) 
 
9. What did you find least 
 
  
 
  Questions on impact/impairment (#1-6) 
  Question on control (#7) 
  Questions on exacerbations and healthcare resource utilization (#8-10) 
 
10. 
Check all that apply 
  Increased recognition of patients whose asthma placed their health at risk  
  Increased recognition of conditions/risks, comorbidities driving poor asthma control 
  Improved recognition of patient goals 
  Improved patient engagement with their treatment, risk, or control 
  Improved efficiency of patient telehealth visit 
  Improved efficiency of in-person asthma clinic visit 
  Increased educational efforts 
 
11. 
than your own? 
  No different than if I did not have the tools 
  More often than before 
  Less often than before 
 
12. What features of the PRECISION program did you find most useful? 
___________________________________________ 
______________________________________________ 
______________________________________________ 
13. What features of the PRECISION program do you think could be improved? 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
98 
______________________________________________ 
______________________________________________ 
______________________________________________ 
14. How important was it for you to use the Assess component of the Asthma Checklist (page 
1) with the AIRQ? 
  Very important  
  Somewhat important 
  Not at all important 
  Did not use 
 
15. How important was it for you to use the Adjust and Review components of the Asthma 
Checklist (pages 2 and 3)? 
  Very important  
  Somewhat important 
  Not at all important 
  Did not use 
 
16. How important do you feel it would be for PCPs to use the Assess component of the 
Asthma Checklist (page 1) with the AIRQ? 
  Very important  
  Somewhat important 
  Not at all important 
   Did not use 
 
17. How important do you feel it would be for Specialists to use the Adjust/Review pages of 
the Asthma Checklist with the AIRQ?  
  Very important  
  Somewhat important 
  Not at all important 
   Did not use 
 
18. How important do you feel it would be for Non-prescribers to use the Assess component 
of the Asthma Checklist (page 1) with the AIRQ?   
  Very important  
  Somewhat important 
  Not at all important 
   Did not use 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
99 
19. Do you have any other comments or suggestions? 
______________________________________________ 
______________________________________________ 
______________________________________________ 
APPENDIX V. SEMI-STRUCTURED INTERVIEW GUIDES 
INTERVIEW GUIDE: KEY CLINICAL SITE STAFF 
Interviewer:  Before you meet with the participant for the interview, be sure to look over 
answers from the Post-
Questionnaire about whether the site has indicated any specific initiative to achieve with the 
the site unique for participating in this study. 
Part 1. Before the interview begins, be sure to document verbal consent using the script below  
Part 2. Below is the discussion guide, it is to be used as a guide only. The actual areas of 
conversation are fluid and may be discussed at moments different from the order appearing 
below.  
PART 1. KEY CLINICAL SITE STAFF INFORMED VERBAL CONSENT SCRIPT 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
100 
PART 2. INTERVIEW  
INTERVIEW RULES FOR ALL INTERVIEWS 
Please feel free to answer honestly. We are interested in your feedback and observations from 
implementing these tools in your clinical practice over the past several months.  
Turn on Recorder and Begin Interview: This is [
 name] with participant 
[participant ID] for Study EVA-26645-04 on [Date]. I want to confirm that you agree to 
Is 
that correct? 
____ 
Background 
First, I would like to ask you some background questions. 
1. What are your key responsibilities at the clinic? 
2. What were your key responsibilities for this implementation study? 
3. In general, how did your site conduct the patient visit? Probe: by telehealth platform, 
by in-person clinic visit.?  
4. In general, how did your site conduct the telehealth visits? Probe: by telephone, 
computer, tablet, etc.?  
Now I would like to ask you some questions about the process you used to administer the 
AIRQ
 as part of 
telehealth visit for this study. 
Process for Telehealth visit 
 
5. In your own words, how would you describe the process you used to administer the 
AIRQ
 to patients during a telehealth visit? (listen for who administered AIRQ
 and 
how it was administered and process (i.e., as part of initial intake, by HCP, etc.) 
6. Approximately how long did it take patients to complete just AIRQ
 during a 
telehealth visit? 
7. Did patients have any problems completing the AIRQ
 as part of the telehealth visit? 
a. Did they ask you questions about specific items included in the AIRQ
?  If so, 
what type of questions did they generally ask?  
8. 
 
Process for In-
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
101 
9. In your own words, how would you describe the process you used to administer the 
-person visit? (listen for who administered AIRQ
 
and how it was administered and process (i.e., as part of initial intake, by HCP, etc.) 
10. 
-
person visit? 
11. 
 of the in-person visit? 
12. 
administer the Spanish version?  Were there any difficulties using the Spanish version?  
Going back and forth between English and Spanish versions? 
13. 
 
Asthma Checklist and Educational Resources  
14. Did you use the full Asthma Checklist and education resources from the study 
website?  If so,  
a. In what capacity did you use this information? (telehealth vs in-person) 
b. What did you find most useful about this information?  
c. What did you find least useful about this information? 
Entire Program 
15. Thinking about the entire PRECISION program, how much extra time at each patient 
telehealth visit did it take to incorporate the AIRQ
 as part of the telehealth visit?  
What about in-person visits? 
16. Were there any specific steps or initiatives taken at your clinical site to implement the 
AIRQ
 for telehealth? Please explain. 
17. What were some of the initial challenges of incorporating the PRECISION tools into 
your daily clinical practice? Probe: implementing AIRQ
 on the telehealth platform 
and incorporating AIRQ
 to the regular in-person telehealth visit? 
18. How were you able to overcome these challenges? 
19. What challenges remained throughout the study? 
20. How can we address these challenges during future site trainings? 
21. Which aspects of the PRECISION program are you most likely to continue using, and 
why?  Which ones had the least value to your clinical practice/ 
Overall Comments 
22. What did you think of the overall PRECISION program? 
23. What do you think needs to be done to support the continued use of the PRECISION 
program at your clinical site? 
24. Do you have any other comments or suggestions? 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
102 
INTERVIEW GUIDE: CLINICIAN 
Interviewer:  Before you meet with the participant for the interview, be sure to look over 
answers from the Post-
Questionnaire about whether the site has indicated any specific initiative to achieve with the 
the site unique for participating in this study. 
Part 1. Before the interview begins, be sure to document verbal consent using the script below  
Part 2. Below is the discussion guide, it is to be used as a guide only. The actual areas of 
conversation are fluid and may be discussed at moments different from the order appearing 
below.  
PART 1. CLINICIAN INFORMED VERBAL CONSENT SCRIPT 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
103 
PART 2. INTERVIEW  
INTERVIEW RULES FOR ALL INTERVIEWS 
Please feel free to answer honestly. We are interested in your feedback and observations from 
implementing these tools in your clinical practice over the past several months.  
Turn on Recorder and Begin Interview: This is [
 name] with participant 
[participant ID] for Study EVA-26645-04 on [Date]. I want to confirm that you agree to 
Is 
that correct? 
____ 
Background 
1. What are your overall thoughts on the AIRQ
, the Asthma Checklist, and educational 
resources (PRECISION program)?  Probe: Assess component, Review/Adjust 
component of Asthma checklist 
2. How useful was the AIRQ
 when used during a telehealth visit?  Probe: identify 
patients at risk, guide treatment, and asthma work-up and management?  
3. 
 when used during an in-person visit?  Probe: identify 
patients at risk, guide treatment, and asthma work-up and management?  
4. Were there specific questions on the AIRQ
 that you thought were the most useful?  
The least useful? 
5. How useful were the Asthma Checklist and other educational resources as part of the 
telehealth platform?  In-person visit? 
6. What did you like about the PRECISION program? 
7. What did you not like about the PRECISION program? 
Interviewer:  Remind the clinician of any specific initiative they thought they could 
achieve with the AIRQ
, the Asthma Checklist, and educational resources (PRECISION 
program) or what made them unique for participating in this study before the interview. 
1. When you started this study, you had indicated [specific QI initiatives/uniqueness of 
site].  Can you speak to this a bit?  How has AIRQ
, the Asthma Checklist, and 
education resources (PRECISION program) been incorporated into this initiative?  
How has it helped?  What were some of the challenges/benefits? 
2. Will your site continue to incorporate the AIRQ
, Asthma Checklist, and educational 
resources (PRECISION program) when the study is over? Why or why not?  
3. What do you think needs to be done to support the continued use of the PRECISION 
program in your clinical practice? 
Do you have any other comments or suggestions?  

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
104 
 
 
 
CCI

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
105 
APPENDIX X. ADVERTISEMENT 
 

PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
107 
APPENDIX Z. E-MAIL FOR POST VISIT PATIENT SURVEY 
(ENGLISH VERSION)  
APPENDIX AA. E-MAIL FOR POST VISIT PATIENT SURVEY 
(SPANISH VERSION) 
Placeholder 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
108 
APPENDIX BB.  REMINDER E-MAILS FOR POST VISIT PATIENT 
SURVEY (ENGLISH VERSION) 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
109 
APPENDIX CC. REMINDER E-MAILS FOR POST VISIT PATIENT 
SURVEY (SPANISH VERSION) 
Placeholder 
 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
110 
APPENDIX DD. DESCRIPTION OF DRUGS IN EACH DRUG CLASS 
MAINTENANCE PHARMACOLOGIC THERAPY  
ICS 
  QVAR HFA 40 mcg (Beclomethasone) 
  Beclovent HFA 40 mcg (Beclomethasone) 
  Vanceril HFA 42 mcg (Beclomethasone) 
  QVAR HFA 80 mcg (Beclomethasone) 
  Beclovent HFA 80 mcg (Beclomethasone) 
  Vanceril HFA 84 mcg (Beclomethasone) 
  QVAR Redihaler 40 mcg (Beclomethasone) 
  QVAR Redihaler 80 mcg (Beclomethasone) 
  Pulmicort Flexhaler 90 mcg (Budesonide) 
  Pulmicort Flexhaler 180 mcg (Budesonide) 
  Pulmicort Respules 0.25 mg (Budesonide) 
  Pulmicort Respules 0.5 mg (Budesonide) 
  Pulmicort Respules 1 mg (Budesonide) 
  Aerospan HFA 80 mcg (Flunisolide) 
  Flunisolide 
  Flovent HFA 44 mcg (Fluticasone Propionate) 
  Flovent HFA 110 mcg (Fluticasone Propionate) 
  Flovent HFA 220 mcg (Fluticasone Propionate) 
  Flovent Disc 50 mcg (Fluticasone Propionate) 
  Flovent Disc 100 mcg (Fluticasone Propionate) 
  Flovent Disc 250 mcg (Fluticasone Propionate) 
  Azmanex Twisthaler 110 mcg (Mometasone) 
  Azmanex Twisthaler 220 mcg (Mometasone) 
  Azmanex HFA 100 mcg (Mometasone) 
  Azmanex HFA 220 mcg (Mometasone) 
  Arnuity Ellipta 100 mcg (Fluticasone Furoate) 
  Arnuity Ellipta 200 mcg (Fluticasone Furoate) 
  Triamcinolbone Acetonide 
  Alvesco 80 mcg (Ciclesonide) 
  Alvesco 160 mcg (Ciclesonide) 
  Other (specify): ______________________ 
  Other (specify): ______________________ 
ICS/LABA 
  Advair Diskus 100/50 (Fluticasone/Salmeterol) 
  Advair Diskus 250/50 (Fluticasone/Salmeterol) 
  Advair Diskus 500/50 (Fluticasone/Salmeterol) 
  Advair HFA 45/21 (Fluticasone/Salmeterol) 
LABA (Single inhaled medicine, not in a fixed-dose 
combination with an ICS or ICS/LAMA) 
  Serevent/ Salmeterol 
  Foradil/Formoterol 
  Arcapta 
  Brovana 
  Indacaterol 
  Arformoterol 
  Striverdi/Olodaterol 
LAMA 
  Incruse Ellipta (Umeclidinium) 
  Spiriva Respimat 1.25 mcg (Tiotropium 
bromide) 
  Spiriva Handihaler (Tiotropium bromide 
inhalation powder) 
  Spiriva Respimat 2.5 mcg (Tiotropium bromide) 
  Tudorza/Aclidinium 
Triple Therapy (fixed-dose combination) 
  Trelegy Ellipta 
LTRA 
  Singulair 4 mg (Montelukast) 
  Singulair 5 mg (Montelukast) 
  Singulair 10 mg (Montelukast) 
  Accolate 10 mg (Zafirlukast) 
  Accolate 20 mg (Zafirlukast) 
  Zyflo 600 mg (Zileuton) 
Theophylline Preparations 
  Theo-24 100 mg (Theophylline) 
  Theo-24 200 mg (Theophylline) 
  Theo-24 400 mg (Theophylline) 
  Elixophylline 200 mg (Theophylline) 
  Elixophylline 300 mg (Theophylline) 
  Elixophylline 400 mg (Theophylline) 
  Theochron 100mg (Theophylline) 
  Theochron 200mg (Theophylline) 
  Theochron 300mg (Theophylline) 
  Theochron 400mg (Theophylline) 
Chronic Add-on Therapy (Macrolides) 
  Azithromycin (Zithromax) 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
111 
MAINTENANCE PHARMACOLOGIC THERAPY  
  Advair HFA 115/21 (Fluticasone/Salmeterol) 
  Advair HFA 230/21 (Fluticasone/Salmeterol) 
  Wixela Inhub 100/50 
  Wixela Inhub 250/50  
  Wixela Inhub 500/50  
  Airduo Respiclick 55/14 (Fluticasone/ 
Salmeterol) 
  Airduo Respiclick 133/14 (Fluticasone/ 
Salmeterol) 
  Airduo Respiclick 232/14 (Fluticasone/   
Salmeterol) 
  Breo Ellipta 100/25 (Fluticasone/Vilanterol) 
  Breo Ellipta 200/25 (Fluticasone/Vilanterol) 
  Dulera HFA 100/5 (Mometasone/Formoterol) 
  Dulera HFA 200/5 (Mometasone/Formoterol) 
  Symbicort 80/4.5 (Budesonide/Formoterol) 
  Symbicort 160/4.5 (Budesonide/Formoterol) 
  Clarithromycin (Biaxin) 
  Erythromycin (Erythrocin) 
Biologics 
  Cinqair (reslizumab) 
  Dupixent (dupilumab) 
  Fasenra (benralizumab) 
  Nucala (mepolizumab) 
  Xolair (omalizumab) 
  Other:_____________ 
 
 
 
 
 

Observational Study Protocol 
Study Code D2287L00028 [EVA-26645-03] 
Version 2.0 
Date June 16, 2022 
 
Observational Study Protocol Form 
Version 3.0 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328 
112 
8. 
SIGNATURES 
ASTRAZENECA SIGNATURE(S) 
 
 
 
Implementation of the US PRECISION AIRQ, Asthma Checklist, and 
Educational Resources (PRECISION Program) into Clinical Practice Using 
Telehealth and In-person Platforms  
 
This Community Program intervention Study Protocol version 2 has been subjected to an 
internal AstraZeneca review. 
I agree to the terms of this Study protocol. 
AstraZeneca representative 
 
 
Date 
(Day Month Year) 
 
Date  
(Day Month Year) 
 
 
 
 
 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from AstraZeneca.  
 
 
 
PPD
PPD

PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD