A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
Phase: PHASE4
Conditions: Common Cold, Cough
Sponsor: HALEON

Property of Haleon – Confidential 
May not be used, divulged, published or otherwise disclosed without the consent of Haleon 
CLINICAL PROTOCOL 
A Real-World Evidence study evaluating Quality of Life parameters 
following treatment with Robitussin 
Protocol Number: 
300233 
Compound/Product Names: 
- Robitussin Maximum Strength Cough and Chest
Congestion DM (Dextromethorphan HBr, USP 20 mg and
Guaifenesin, USP 400 mg)
- Robitussin Maximum Strength Nighttime Cough DM
(Dextromethorphan HBr, USP 30 mg and
Doxylamine Succinate, USP 12.5 mg)
Phase: 
IV 
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This document contains confidentiality statements that are not relevant for this
publicly available version

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Sponsor Information 
    
Sponsor Name & Legal Registered 
Address: 
 
Haleon (UK)  
Building 5, First Floor,  
The Heights,  
Weybridge,  
Surrey,  
KT13 0NY 
 
Sponsor Contact Details: 
 
Haleon 
184 Liberty Corner Road,  
Warren, NJ, 07059 
USA 
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Document History 
 
Document 
Version 
Summary of Changes  
Original protocol 
1.0 
Not applicable (N/A) 
 
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Principal Investigator Protocol Agreement Page 
● I confirm agreement to conduct the study in compliance with the protocol and any 
amendments according to the current Good Clinical Practice guidelines (GCP). 
● I acknowledge that I am responsible for overall study conduct. I agree to personally conduct 
or supervise the described study. 
● I agree to ensure that all associates, colleagues and employees assisting in the conduct of 
the study are informed about their obligations. Mechanisms are in place to ensure site staff 
receives all appropriate information throughout the study. 
● I agree to conduct this study in full conformance with the laws and regulations of the 
country in which the research is conducted and the ethical principles that have their origin 
in the Declaration of Helsinki. 
 
Investigator Name: 
 
Investigator Qualifications: 
 
Investigator Signature: 
Date of Signature/Agreement: 
 
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PPD
PPD
PPD

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Table of Contents 
1 
INTRODUCTION ...................................................................................................... 8 
1.1 
Study Rationale ............................................................................................... 8 
1.2 
Background ..................................................................................................... 8 
1.3 
Mechanism of Action/Indication .................................................................. 10 
2 
STUDY OBJECTIVES AND ENDPOINTS ............................................................ 11 
3 
STUDY DESIGN ..................................................................................................... 12 
3.1 
Overall Design .............................................................................................. 12 
3.2 
Scientific Rationale for Study Design ........................................................... 12 
3.3 
Justification for Dose .................................................................................... 13 
3.4 
End of Study Definition ................................................................................ 13 
4 
STUDY POPULATION ........................................................................................... 13 
4.1 
Type and Planned Number of Subjects ......................................................... 13 
4.2 
Statistical Analysis: ....................................................................................... 14 
4.3 
Inclusion Criteria .......................................................................................... 14 
4.4 
Exclusion Criteria ......................................................................................... 15 
4.5 
Lifestyle Considerations ............................................................................... 16 
5 
STUDY ASSESSMENTS ........................................................................................ 16 
5.1 
Schedule of Activities ................................................................................... 16 
5.2 
Pre-screening ................................................................................................. 17 
5.2.1 
Informed Consent ......................................................................... 18 
5.3 
Screening & Baseline Questionnaires ........................................................... 18 
5.3.1 
Demographics ............................................................................... 18 
5.3.2 
Medical History and Prior Medication/Treatment ....................... 18 
5.4 
Virtual Visit .................................................................................................. 19 
5.4.1 
Verification of Identity ................................................................. 19 
5.4.2 
Baseline Assessments ................................................................... 19 
5.4.3 
Eligibility Review ......................................................................... 19 
5.4.4 
Enrolled Subjects and Screen Failures ......................................... 20 
5.4.5 
Randomization .............................................................................. 20 
5.5 
Treatment Period ........................................................................................... 21 
5.6 
End of Treatment Period ............................................................................... 21 
5.7 
Study Conclusion .......................................................................................... 22 
5.8 
Follow-Up Phone Call .................................................................................. 22 
6 
STUDY ASSESSMENTS ........................................................................................ 22 
6.1 
Outcome Assessments .................................................................................. 22 
6.2 
Safety and Other Assessments ...................................................................... 22 
6.2.1 
Pregnancy Testing ........................................................................ 23 
7 
STUDY PRODUCTS ............................................................................................... 23 
7.1 
Study Product Supplies ................................................................................. 23 
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7.2 
Product Supplies, Product Storage, Accountability, Returns and Destruction
 ....................................................................................................................... 24 
7.3 
Blinding and Randomization ........................................................................ 24 
7.4 
Breaking the Blind ........................................................................................ 24 
8 
STATISTICAL CONSIDERATIONS AND DATA ANALYSES .......................... 24 
8.1 
Sample Size Determination ........................................................................... 24 
8.2 
Populations for Analysis ............................................................................... 25 
8.2.1 
Definitions of Analysis Populations ............................................. 25 
8.3 
Statistical Analyses ....................................................................................... 25 
8.3.1 
Exclusion of Data from Analysis ................................................. 25 
8.3.2 
Primary Endpoint Analysis(es) ..................................................... 26 
8.3.3 
Secondary Endpoint Analysis(es) ................................................. 26 
8.3.4 
Safety Analysis(es) ....................................................................... 27 
8.3.5 
Exploratory Analysis(es) .............................................................. 27 
8.3.6 
Demographic and Baseline Characteristics .................................. 27 
8.3.7 
Study Product Compliance and Use of Other Therapies .............. 27 
8.3.8 
Handling of Dropouts and Missing Data ...................................... 27 
9 
ADVERSE EVENT (AE) AND SERIOUS AE (SAE) ............................................ 27 
9.1 
Definition of an Adverse Event (AE) ........................................................... 28 
9.2 
Definition of a Serious Adverse Event ......................................................... 28 
9.3 
Time Period and Frequency for Collecting AE and SAE Information ......... 30 
9.4 
Reporting Procedures .................................................................................... 30 
9.5 
Reporting an AE ........................................................................................... 31 
9.6 
Reporting an SAE ......................................................................................... 31 
9.7 
Evaluating AEs ............................................................................................. 32 
9.8 
Follow-up of AEs and SAEs ......................................................................... 33 
9.9 
Withdrawal Due to an Adverse Event ........................................................... 33 
9.10 
Regulatory Reporting Requirements for SAEs ............................................. 33 
9.11 
Pregnancy ...................................................................................................... 34 
9.11.1 
Time Period for Collecting Pregnancy Information ..................... 34 
9.11.2 
Action to be Taken if Pregnancy Occurs ...................................... 34 
10 DISCONTINUATION OF STUDY INTERVENTION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL ................................................................ 34 
10.1 
Discontinuation of Study Product ................................................................. 34 
10.1.1 
Subject Discontinuation/Withdrawal ............................................ 34 
10.1.2 
Lost to Follow up .......................................................................... 35 
11 DATA MANAGEMENT ......................................................................................... 35 
11.1 
Case Report Form ......................................................................................... 35 
11.2 
Data Handling ............................................................................................... 35 
11.2.1 
Data Queries ................................................................................. 36 
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11.3 
Processing Patient Reported Outcomes and Data Collection from Internet of 
Medical Things ............................................................................................. 36 
12 STUDY GOVERNANCE CONSIDERATIONS ..................................................... 37 
12.1 
Quality Control ............................................................................................. 37 
12.2 
Quality Assurance ......................................................................................... 37 
12.3 
Regulatory and Ethical Considerations ......................................................... 38 
12.4 
Institutional Review Board/ Ethics Committee ............................................ 38 
12.5 
Ethical Conduct of the Study ........................................................................ 38 
12.6 
Subject Information and Consent .................................................................. 38 
12.7 
Subject Recruitment ...................................................................................... 38 
12.8 
Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
 ....................................................................................................................... 39 
12.9 
Oversight Committees .................................................................................. 39 
12.10 Disclosure and Publication Policy ................................................................ 39 
12.11 Provision of Study Results to Investigators .................................................. 39 
12.12 Records Retention ......................................................................................... 40 
12.13 Conditions for Terminating the Study .......................................................... 40 
13 REFERENCES ......................................................................................................... 41 
14 APPENDICES .......................................................................................................... 42 
14.1 
Schedule of Assessments Schematic ............................................................. 42 
14.2 
Study Assessments ........................................................................................ 47 
14.2.1 
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21)
 ...................................................................................................... 47 
14.2.2 
Specific Quality of Life (QoL)Questions ..................................... 47 
15 ABBREVIATIONS .................................................................................................. 49 
 
List of in text tables 
Table 2-1 Study Objectives and Endpoints 
10 
Table 5-1 Schedule of Activities 
15 
Table 7-1 Investigational/Study Product Supplies 
20 
Table 15-1 Abbreviations 
37 
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1 
INTRODUCTION 
1.1 
Study Rationale 
Real world evidence (RWE) studies offer an opportunity to gather information of a marketed 
product in real-world heterogeneous populations that can complement clinical evidence, 
consumer insight data, and post-marketing surveillance. Real world data (RWD) generation is 
increasingly important in determining effectiveness outside of the tightly controlled conditions 
of randomized controlled trials (RCTs), that do not always reflect real-world patient 
populations, limiting their generalizability and external validity (Sherman et al., 2016). 
This decentralized study is designed to generate real world data from subjects with cough 
associated with the common cold, evaluating the effects in two arms with commercially 
available cough syrups on health-related quality of life. Arm 1 includes one cough syrup (which 
can be used day or night) and Arm 2 includes the daytime cough syrup and a nighttime cough 
syrup. 
Robitussin Maximum Strength Cough and Chest Congestion DM (Dextromethorphan HBr, 
USP 20 mg; Guaifenesin, USP 400 mg) and Robitussin Maximum Strength Cough and Chest 
Congestion DM + Robitussin Maximum Strength Nighttime Cough DM (Dextromethorphan 
HBr, USP 30 mg; Doxylamine Succinate, USP 12.5 mg) are marketed cough and congestion 
syrups used for treatment of cough associated with common cold. Although this is a non-life-
threatening condition, it impacts individuals’ ability to function normally in day-to-day 
activities (physical, social, occupational, and emotional). 
Based on a large national on-line survey conducted in the United States (ACHOO survey) 
(Blaiss et al., 2015, Dicpinigaitis et al., 2015), Cough was the most common cold symptom 
(73.1%) and had a delayed onset (typically 1–5 days after cold onset) and a long duration (>6 
days in 35.2%). Nasal congestion and cough were the most bothersome symptoms (Blaiss et 
al., 2015). Overall, 93% of survey participants reported sleep difficulty (slight to extreme) 
during a cough/cold. Among all respondents, 57% reported cough or nasal congestion as the 
symptoms making sleep difficult (Dicpinigaitis et al., 2015).  In a similar RWE study, it was 
demonstrated that associated cold symptoms like blocked nose can impact overall quality of 
life and also that treatment can provide clinically meaningful improvements in QoL. 
This study will generate data to support the effectiveness of the Robitussin syrups in the real-
world setting to suppress cough among individuals with common cold to understand how the 
effect can influence their quality of life. 
1.2 
Background 
Dextromethorphan, guaifenesin, and doxylamine are included in the FDA OTC Drug 
Monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, 
which ensures their safety and efficacy as non-prescription medications. Dextromethorphan is 
an antitussive that works by suppressing the cough reflex in the brain, making it effective for 
temporary relief of coughs due to minor throat and bronchial irritation, such as from the 
common cold. Doxylamine, an antihistamine, blocks histamine H1 receptors to relieve 
symptoms like sneezing, runny nose, and itchy eyes associated with hay fever, allergic rhinitis, 
and the common cold. Guaifenesin, an expectorant, helps thin and loosen mucus in the airways, 
making it easier to clear congestion through productive coughing. The FDA monograph 
provides clear usage guidelines, ensuring safe access to these medications for both adults and 
children without a prescription. 
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Dextromethorphan's clinical efficacy has been demonstrated in several studies. In Parvez 
(Parvez, 1996), three successive trials involving 451 adults showed that a single 30 mg dose 
significantly reduced cough counts compared to placebo, with differences ranging from 19% 
to 36% (P < 0.05). Cough counts were measured using cough acoustic signals, and the studies 
reported a net difference of 8-10 coughing bouts every 30 minutes. In a meta-analysis (Pavesi, 
2001) of 710 subjects, a single 30 mg dose of dextromethorphan was tested using continuous 
cough recording over three hours. This study measured cough bouts, components, effort, 
intensity, and latency. The average treatment difference was 12% to 17% in favor of 
dextromethorphan for cough bouts (P value = 0.004), cough components (P value = 0.003) and 
cough effort (P value = 0.001), with an increase in cough latency (P value = 0.002). These 
studies reflect dextromethorphan’s long-standing reputation as a reliable, non-prescription 
treatment for acute cough, complementing its well-established role in OTC medications. 
The efficacy of guaifenesin as an expectorant has been demonstrated in studies involving both 
acute upper respiratory tract infections (URTIs) and chronic respiratory conditions such as 
chronic bronchitis. In a study by Robinson and colleagues (Robinson, 1977), guaifenesin was 
shown to significantly improve symptoms in patients with acute URTIs based on subjective 
patient assessments. Compared to placebo, guaifenesin reduced cough frequency and intensity 
at 48 and 72 hours (p < 0.01), and it also decreased chest discomfort at 24, 48, and 72 hours (p 
< 0.01). Additionally, in patients with productive coughs, guaifenesin increased sputum 
volume at 48 hours (p < 0.01) and made it easier to raise sputum at 24, 48, and 72 hours (p < 
0.01). Given its proven efficacy, guaifenesin holds a well-established position as an OTC 
expectorant, offering consumers an accessible and effective treatment for chest congestion. 
The efficacy of doxylamine in alleviating symptoms of runny nose and sneezing associated 
with the common cold was demonstrated in a clinical study involving cold sufferers (Eccles, 
1995). The study involved 688 patients with cold symptoms who were randomized to receive 
either doxylamine succinate 7.5 mg four times daily (n = 345) or a placebo (n = 343). Results 
showed that doxylamine significantly reduced runny nose scores (P < 0.01) and sneezing scores 
(P < 0.001) compared to placebo. These findings suggest that doxylamine is an effective 
antihistamine in managing cold-related symptoms. 
Cough is a common symptom associated with upper respiratory infections, particularly those 
caused by the common cold, which is predominantly viral in origin. The common cold affects 
millions of individuals worldwide, leading to significant morbidity and healthcare resource 
utilization. While cough serves as a protective reflex, persistent or bothersome cough can 
adversely impact quality of life, sleep, and daily activities. 
The common cold represents the most frequent human disease (Stein, 2017). Its most relevant 
definition is a common viral infection of the nose or throat, with symptoms such as sore throat, 
runny nose, sneezing, and nasal congestion, clear discharge (mucus) from the nose, and body 
aches (Hemila, 2017). The trajectory of common cold symptoms caused by viruses can vary 
among individuals but does generally follow a familiar pattern. Cold symptoms tend to peak at 
1 to 3 days after first appearance, thereafter symptoms usually last from 3 to 10 days. The 
mucus appearance may also change during this period. For some people the symptoms of 
common cold may linger a few more days, especially runny nose, stuffy nose, and coughing. 
Although common cold symptoms are usually mild, they represent a huge burden for society 
in terms of impaired QoL and economic losses (Passioti et al., 2014, Heikkinen and Jarvinen, 
2003). While rhinoviruses are the predominant cause of the common cold, the aetiologic agent 
remains unknown in up to half of all upper respiratory tract infections (URTIs) (Stein, 2017). 
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For the common cold, only symptomatic treatments exist (Passioti et al., 2014, Stein, 2017). 
Most people require no prescription medications or doctor visits but do use a variety of over-
the-counter (OTC) medications for relief of symptoms. 
1.3 
Mechanism of Action/Indication 
Dextromethorphan is a centrally acting cough suppressant, and its primary mechanism of action 
involves inhibiting the activity of the medullary cough center in the brainstem, which reduces 
the cough reflex. 
Guaifenesin is an expectorant and its primary mechanism of action is to help loosen and thin 
mucus in the airways, making it easier to cough up and clear from the respiratory tract. It 
reduces sputum viscosity by increasing the volume and water content of the bronchial 
secretions, thereby facilitating the expectoration of sputum.  
Doxylamine is an antihistamine, and its primary mechanism of action involves blocking 
histamine H1 receptors. By inhibiting these receptors, doxylamine reduces the effects of 
histamine, a chemical in the body that causes symptoms such as sneezing, runny nose, itching, 
and watery eyes as may occur with hay fever or other respiratory allergies. 
 
Robitussin Maximum Strength Cough and 
Chest Congestion DM 
Robitussin Maximum Strength Nighttime Cough 
DM 
Active ingredients (in each 20 ml) and purposes 
Dextromethorphan HBr, USP 20 mg - Cough 
suppressant 
Guaifenesin, USP 400 mg - Expectorant 
Active ingredients (in each 20 mL) and purposes 
Dextromethorphan HBr, USP 30 mg - Cough 
suppressant 
Doxylamine Succinate, USP 12.5 mg - 
Antihistamine 
Uses 
● 
Temporarily relieves cough due to 
minor throat and bronchial irritation as 
may occur with a cold 
● 
Helps loosen phlegm (mucus) and thin 
bronchial secretions to drain bronchial 
tubes  
Uses 
● 
Temporarily relieves cough due to minor 
throat and bronchial irritation as may occur 
with a cold 
● 
Temporarily relieves these symptoms due 
to hay fever or other upper respiratory 
allergies: 
○ 
runny nose 
○ 
sneezing 
○ 
itchy, watery eyes 
○ 
itching of the nose or throat 
○ 
controls the impulse to cough to help 
you sleep 
 
 
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2 
STUDY OBJECTIVES AND ENDPOINTS 
Table 2-1 
Study Objectives and Endpoints 
Each of the treatment groups will be analyzed separately; there is no comparison between the 
study groups (daytime product only and daytime/nighttime product combination). 
Objectives  
Endpoints  
Primary  
To evaluate the over-time effects of Robitussin 
on QoL factors and common cold symptoms 
among individuals experiencing cough 
associated with common cold, following up to 8      
days of treatment using WURSS-21. 
 
Score change from Baseline to each 
treatment day in: 
● 
WURSS-21 total score 
● 
WURSS-21 total symptom 
domain score  
● 
WURSS-21 total QoL domain 
score 
● 
Each of the WURSS-21 symptom 
scores (10 items in total) 
● 
Each of the WURSS-21 QoL 
scores (9 items in total) 
Secondary  
To evaluate the over-time effects of Robitussin 
on QoL factors among individuals experiencing 
cough associated with common cold, following up 
to 8      days of treatment, using specific QoL 
questions. 
 
Score change from Baseline to each 
treatment day in: 
● 
social activities  
● 
feeling self-conscious around 
people 
● 
coughing in public 
● 
falling asleep  
● 
sleeping through the night 
● 
energy 
● 
motivation  
To evaluate the over-time effects of Robitussin 
on specific QoL questions among individuals 
experiencing cough associated with common 
cold, following up to 8      days of treatment, using 
categorized QoL factors. 
 
Score change from Baseline to each 
treatment day in: 
● 
Sleep quality 
● 
Vitality 
● 
Physical activities 
● 
Social activities  
Safety  
To record adverse events (AEs) during study 
period 
 
Number and percent of patients reporting 
AEs or serious AEs (SAEs) while on 
treatment: 
● 
Related to product 
● 
Not related to product 
Exploratory 
Subgroup analysis for primary and secondary 
endpoints 
Subgroups: 
● 
Excluding subjects who took 
concomitant medications that are 
known to have an impact on 
common cold symptoms 
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3 
STUDY DESIGN  
3.1 
Overall Design 
This is a longitudinal, randomized, decentralized, open-label study evaluating the effect on 
QoL factors in subjects with cough associated with the common cold in two arms using 
Robitussin Maximum Strength in a real-world setting. A sufficient number of adults (approx. 
372) aged 18 and over with symptoms of common cold will be screened for eligibility. The 
study expects to enroll approximately 260 eligible subjects across the United States with a total 
of 200 subjects expected to complete the study, approximately 100 in each study group. 
Subjects will be randomized into one of two study groups (at a 1:1 ratio):  
● Group 1 will take Robitussin Maximum Strength Cough and Chest Congestion DM  
● Group 2 will take Robitussin Maximum Strength Cough and Chest Congestion DM + 
Robitussin Maximum Strength Nighttime Cough DM.  
Subjects will be recruited through targeted advertising on social media channels. This study is 
entirely decentralized, and subjects will not be required to physically attend any on-site visits. 
All study data will be collected remotely through a study platform using the subject’s own 
mobile device, tablet, or computer. 
Detailed study procedures can be found in Section 5 of the protocol.   
 
3.2 
Scientific Rationale for Study Design 
RWE studies reflect product use in everyday life. They offer the opportunity to gather 
information on currently marketed products to not only substantiate clinical evidence, but to 
gather information on participant quality of life from the target patient population. 
The Wisconsin Upper Respiratory Symptom Survey (WURSS) is an evaluative illness-specific 
quality of life instrument, designed to assess daily the negative impact of acute upper 
respiratory infection, presumed viral (the common cold). WURSS-21 is the short version of 
this validated instrument. WURSS-21 includes a single question on a global severity score, a 
symptoms domain (10 items), a functional domain (9 items) and an overall question on 
improvement/deterioration since yesterday. While the WURSS-44 covers more symptoms, the 
WURSS-21 exhibits similar performance in terms of reliability, responsiveness, importance-
to-patients, and convergence with other measures. 
Subjects with cough associated with common cold, who seek to treat with study treatment 
(Robitussin) will complete WURSS-21 and a specific QoL questionnaire once per day. Study 
treatment use will be reported via electronic diaries (eDiary). These measures will provide 
information on the effects of Robitussin over the natural course of their cough associated with 
common cold. This supports evaluation of the daily effects that may be attributable to the study 
treatment. 
Limitations of the study 
Given the natural course of the common cold, data collected during this study may be 
confounded by the natural resolution of the disease. Within 24 hours of cold onset, most 
patients report an escalation in the number of symptoms they experience, including sore throat, 
nasal congestion, runny nose, and headache. Over the initial days of having a cold, sore throat 
appears to be most bothersome on day 1 followed by nasal congestion and then cough. 
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Given the natural course of the disease, making sure subjects have access to treatment when 
cough symptoms are at their peak will allow for subsequent QoL data capture, reducing the 
influence of confounding variables. 
There is substantial evidence to show that different symptoms of common cold overlap during 
the natural course of the disease. Subjects may likely be using over-the-counter 
antipyretics/analgesics for fever and/or headache, which may influence their overall QoL and 
confound data collected. During this study patients will be prompted to report medications they 
take for symptom relief, along with any changes in medication over the course of their study 
participation, which will allow the study team to review collected data objectively. Subjects 
who report taking medication(s) known to have an impact on common cold symptoms will be 
excluded for subgroup analysis. 
3.3 
Justification for Dose 
Dosing instructions will be followed as listed on the study product commercial label. 
3.4 
End of Study Definition 
A subject is considered to have completed the study if they have completed all procedures and 
assessments of the study including the last scheduled procedure shown in the Schedule of 
Activities. 
Subjects will have the option to discontinue treatment at their discretion, if they determine they 
no longer want treatment. The end of the treatment period      per subject is tentatively defined 
as Day 7 but may vary based on the need/severity of cough (see section 5 for further details). 
At the end of study, each subject should complete an end of study survey including product 
satisfaction. 
The end of study is defined as the last data collection from the last subject participating in the 
study. 
4 
STUDY POPULATION 
4.1 
Type and Planned Number of Subjects 
Adult subjects aged 18 and over (inclusive), of any race/ethnicity, reporting symptoms of the 
common cold including cough and at least one other common cold symptom (scratchy throat, 
sore throat, nasal congestion or watery nasal discharge) onset within the previous 48 hours will 
be screened for enrollment into the study. No discrimination of any kind (e.g. social class, 
gender, skin color, ethnicity) should preclude eligible participants from participating in the 
study. The study will aim to recruit a diverse population representative of the US census. 
 
Sufficient subjects will be screened in order to enroll approximately 260 eligible subjects 
(approximately 130 subjects per study group). This study assumes an approximate 30% drop 
out rate. A total of 200 subjects are expected to complete the study (approximately 100 subjects 
per study group, allowing for up to 30% dropouts). Potential participants will be recruited 
through targeted digital advertising campaigns.  
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4.2 
Statistical Analysis: 
Sample size: 
The study will be sufficiently powered to demonstrate statistically significant differences 
between QoL parameters in changes from Baseline to each treatment day as measured by the 
WURSS-21 (primary objective). Further details on the sample size determination can be found 
in section 8.1. 
This study can fulfill its objectives only if appropriate subjects are enrolled. All relevant 
medical and non-medical conditions should be taken into consideration when deciding whether 
a subject is suitable for this protocol. Subject eligibility to participate in the clinical study 
should be reviewed and documented by a delegated member of the investigator’s study team 
before subjects are randomized in the study. The following eligibility criteria are designed to 
select subjects for whom participation in the study is considered appropriate.   
Population for analysis: 
A modified intention-to-treat (mITT) analysis will be performed and will include all subjects 
who received at least one dose of the study product(s) and have at least one post-baseline QoL 
questionnaire data to support at least one of the primary endpoint assessments. Any subject 
who is randomized but discontinues without taking any study product will be replaced. Primary 
and secondary analyses will be summarized using the mITT population only. Safety population 
will include all subjects who receive at least one dose of study product(s). Adverse events will 
be summarized using the Safety population. Subgroup analysis is further defined in section 8. 
4.3 
Inclusion Criteria 
An individual must meet all the following inclusion criteria to be eligible to be included into 
the study: 
1. 
Individual provides a signed and dated electronic informed consent document 
indicating that the subject has been informed of and consents to all pertinent aspects of 
the study, before any assessment is performed and individual has reviewed and is 
willing to follow the product label. 
2. 
Individual aged 18 years or older at the time of electronic consent, inclusive of all 
ethnicities, races and gender identities. 
3. 
Individual reporting initiation of cough symptoms within 48 hours prior to initiation of 
the virtual visit.  
4. 
Individual reporting a minimum score of 5 (moderate) for cough associated with 
common cold symptoms and at least one other symptom of common cold (at least mild 
score of 3) as per the WURSS-21 symptom domains.      
5. 
Individual reporting at least one night’s sleep has been disrupted in the previous 2 
nights due to the symptoms of common cold. 
6. 
Individual who is willing to self-treat their cough using the study treatment. 
7. 
Individual who is in good general and mental health. 
8. 
Individual who resides in the United States (except for Hawaii and Alaska). 
9. 
Individual who owns a mobile device with access to stable internet connection and is 
willing to use their device to complete study surveys and assessments per the schedule 
of events. 
10. 
Individual who has not taken any cough products containing dextromethorphan, 
guaifenesin, or doxylamine (e.g. Robitussin, Delsym, Vicks, Mucinex), or cough 
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drops/lozenges containing benzocaine or menthol (e.g. Cepacol, Halls, Ricola) or any 
natural cough products during the study. 
      
4.4 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from the study: 
1. Have a history of allergies (e.g., rash, hives, difficulty breathing, swelling of face, lips, 
tongue, or throat) to any medication or any kind or sensitivity to ingredients in pain, 
cough, cold, and flu products; including the following active ingredients found in the 
Research products: 
● Active Ingredients – dextromethorphan, guaifenesin, doxylamine 
● Inactive Ingredients - anhydrous citric acid, carboxymethylcellulose sodium, FD&C 
blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial 
flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, 
sodium citrate, sucralose, triacetin, xanthan gum 
2. Individual who is currently taking medications that may interact with the study products. 
3. Individual who is pregnant, lactating, or plans to be pregnant or lactating during the 
course of the study (self-report). 
4. Individual who has taken any cough products containing dextromethorphan, guaifenesin, 
or doxylamine (e.g. Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges 
containing benzocaine or menthol (e.g. Cepacol, Halls, Ricola) or any natural cough 
products within 7 days prior to the virtual visit. 
5. Have previously been diagnosed with: 
● prostate gland enlargement or difficulty urinating 
● glaucoma (excessive pressure inside your eyes) 
● asthma, chronic bronchitis, chronic cough or chronic lung disease (difficulty in 
breathing and cough that won’t go away). 
● Pneumonia (within the last 6 months) 
● COVID-19 (within the last month) 
6. Are taking medication(s) to treat - psychiatric / mental health conditions (e.g. anxiety, 
depression) or Parkinson’s disease. Medications such as: 
● MAOI (monoamine oxidase inhibitor) [e.g. Azilect, Emsam, Marplan, Nardil] or have 
stopped them within the last 2 weeks per your doctor’s advice. 
7. Are currently taking sedatives or tranquilizers (e.g. Ambien, Xanax, Klonopin) 
8. Are taking drugs for heart problems such as quinidine, amiodarone or metoprolol, 
antidepressants such as fluoxetine and paroxetine, or antipsychotics  such as haloperidol 
and thioridazine.   
9. Individual who is currently experiencing:  
● cough accompanied by fever, rash, or persistent headache OR  
● cough with too much phlegm. 
10. Individual who is an employee of 
, either directly involved in the conduct 
of the study or a member of their immediate family; or a Haleon employee directly 
involved in the conduct of the study or a member of their immediate family. 
11. Individual who has participated in other studies (including non-medicinal studies) 
involving investigational product(s) within 30 days prior to study entry.  
12. Individual who has previously been enrolled in this study.  
13. Individual sharing the same address as another individual who has been enrolled in this 
study. 
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14. Individual who, in the opinion of the investigator or delegate, should not participate in the 
study, including an individual      who meets any of the “stop use” criteria            
recommended by the label. 
4.5 
Lifestyle Considerations 
As a real-world evidence study, there will be no lifestyle considerations.  
5 
STUDY ASSESSMENTS 
This section lists the procedures and assessments to be completed at each planned study time 
point. However, as per nature of RWE studies, if a subject fails to complete their daily 
questionnaire at any time point post-baseline, subjects will be permitted to continue in the 
study. The timing of each assessment is listed in the Table 5-1 Schedule of Activities section. 
5.1 
Schedule of Activities 
The Schedule of Activities (Table 5-1) provides an overview of the subjects’ virtual visit and 
study assessments. The investigator may schedule additional (unplanned) virtual visits to 
conduct additional evaluations or assessments required to protect the well-being of the subject.  
Table 5-1 
Schedule of Activities 
 
All assessments are completed online. Subjects will receive links via email/text to complete 
questionnaires per the Schedule below. 
 
 
May occur same-daya  
 
 
 
 
 
 
 
Counterparty 
Assessments 
Pre- 
screening 
Screening 
and 
Baseline 
(Virtual 
Visit) 
Day  
0 
Day 
1 
Day 
2 
Day 
3 
Day 
4 
Day 
5 
Day 
6 
Day 
7 
2 Days 
after Last 
Dosej 
Pre-screening Survey 
X 
 
 
 
 
 
 
 
 
 
Informed consent (self-
consent) 
X 
 
 
 
 
 
 
 
 
 
Medical/Medication 
historyb 
 
X 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
ID Verification 
 
X 
 
 
 
 
 
 
 
 
WURSS–21 
questionnairecf 
(Baseline, pre-treatment) 
 
X 
 
 
 
 
 
 
 
 
Specific QoL Questions 
(Baseline, pre-treatment) 
 
X 
 
 
 
 
 
 
 
 
Eligibility Assessment 
 
X 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
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Study product shippede 
 
X 
 
 
 
 
 
 
 
 
Study product useeg 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
WURSS–21 questionnairef 
(post-treatment) 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Specific QoL Questions 
(post-treatment) 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Product Usage eDiaryh 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
End of Study Surveyi 
 
 
 
 
 
 
 
 
X 
 
Concomitant Medication 
Check 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Adverse Event/Serious 
Adverse Event 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
QoL, quality of life; WURSS–21, Wisconsin Upper Respiratory Symptom Survey-21. 
a Pre-screening, Screening and Baseline can occur same day if product is received by subject same-day 
b Medical history including medication history will be self-reported by participant during the virtual visit. 
c Participant eligibility to be confirmed through assessment of inclusion/exclusion criteria and cold symptoms of at least 
mild intensity reported on the Baseline WURSS-21 assessment at the time of Screening. 
d Participant to confirm receipt of study product for study enrollment confirmation and read through detailed instructions 
regarding product dosing; Counterparty staff will be available to answer any queries regarding product use. 
e Robitussin: Group 1: Subjects in Group 1 will be instructed to take up to 20 ml of Robitussin per label instructions for 
up to 8      days or until resolution of symptoms, whichever occurs first. 
Group 2: Subjects in Group 2 will be instructed to take the following per label instructions for up to 8      days or until 
resolution of symptoms, whichever occurs first: 
- up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM 
- up to 20 ml of Robitussin Maximum Strength Nighttime Cough DM 
f WURSS–21 to be completed at the time of Baseline/Screening to confirm eligibility as well as daily during treatment 
(from Day 1 up to Day 7). 
g Study product (Robitussin) to be shipped only after screening/baseline assessments are completed and eligibility is 
confirmed; up to 8      days’ worth of study product(s) will be shipped together to ensure there is no interruption in study 
timeline or treatment duration. 
h Participant will complete an eDiary documenting Robitussin use each day directly through the Citrus ePRO module. 
i Participant-reported End of Study Survey will be completed at the end of study directly through the Citrus ePRO 
module. Participants ending product use early will complete the survey one day after their last reported dose; 
participants dosing on Day 7 will complete the survey on Day 7. 
j Participant-reported Change in Health will be recorded two days after last study product administration. 
5.2 
Pre-screening 
Adult subjects reporting cough associated with common cold onset within the previous 48 
hours who express interest in the study, via social media platform advertising, will be directed 
to complete an online pre-screening questionnaire assessing their eligibility to participate in 
the study. The information collected from the pre-screening questionnaire serves as the 
preliminary screening tool to isolate potentially eligible participants from ineligible subjects.  
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Subjects who successfully pass the pre-screening questionnaire are deemed potentially eligible 
for participation and are directed to complete an online electronic informed consent form 
(eICF).  
5.2.1 
Informed Consent 
The Electronic Informed Consent Form (eICF) is a tool that assists in the consenting process 
by using multimedia components delivered by an electronic system. The eICF process for this 
study will be self-completed on the subject’s mobile device following successful completion 
of the study pre-screening questionnaire. Informed consent must be obtained before any study-
specific activity is performed. Once the eICF has been signed and dated by the subject, the 
subject will be provided with a copy via email. An additional copy of the signed eICF will be 
saved as a Portable Document Format (PDF) in the virtual site file. 
If, during a subject’s participation in the study, the eICF undergoes any changes, each ongoing 
subject should receive a copy of this new information and be re-consented into the study if 
applicable as determined by the IRB. Each subject should be provided with a copy of the signed 
and dated amended consent form.  
Potentially eligible subjects who successfully complete the pre-screening questionnaire and 
execute the eICF will receive the following information: 1) a copy of the signed eICF, 2) an 
email/text invitation to complete the screening and baseline questionnaires and 3) an invitation 
to schedule the Screening & Baseline Virtual Visit. 
5.3 
Screening & Baseline Questionnaires 
Pre-screening and Screening will most likely happen on the same day. After the informed 
consent is executed, subjects will receive links via email/text to complete questionnaires noted 
below.  
5.3.1 
Demographics 
Subjects will self-report the following demographic information:  year of birth and age, sex at 
birth, race, and ethnicity. 
5.3.1.1 
Smoking Status 
Subjects will self-report their current smoking status, inclusive of cigarettes, e-cigarettes, 
vaping, etc. 
5.3.2 
Medical History and Prior Medication/Treatment 
Relevant medical and/or surgical history (in the previous 12 months) will be self-reported, 
including allergies or drug sensitivity and prior medications/treatments, including prescription 
and non-prescription drugs, vaccines, dietary supplements and herbal remedies, that began 
before obtaining informed consent will be recorded as the Medical History/Current Medical 
Conditions.  
Female subjects only:  
● Female subjects who report being pregnant or confirm plans to become pregnant during 
the study will be excluded. 
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● Given the potential impact of pregnancy on study outcomes, female subjects of child-
bearing potential will be reminded to inform the investigator site immediately if 
pregnancy is known or suspected. 
5.4 
Virtual Visit 
The Virtual Visit may occur on the same day that the subject completes the Pre-screening. 
5.4.1 
Verification of Identity 
During the virtual visit, a trained member of the study team will verify the subject's 
government-issued identification (i.e. photo ID such as driver’s license or government issued 
passport) on camera at the beginning of the visit. Should the subject elect not to show a form 
of photo identification or is unable to provide a valid photo identification at the beginning of 
the virtual visit, the visit may be rescheduled, or the subject may be considered a screen failure.  
5.4.2 
Baseline Assessments 
5.4.2.1 
Baseline WURSS-21 
After photo ID verification, the study team will trigger the Baseline WURSS-21 (in appendix 
section 14.3) for subject self-completion. The purpose of this assessment is to ensure potential 
participants meet the Inclusion criteria related to the WURSS-21 Symptom domain [minimum 
score of 5 (moderate) for cough associated with common cold symptoms and at least one other 
symptom of common cold (at least mild score of 3)]. The study team will review responses as 
related to determining subject eligibility. 
This administration of the WURSS-21 at the Virtual Visit also develops the Baseline for 
eligible subjects. 
5.4.2.2 
Baseline Specific Quality of Life Questions 
If the potential participant meets the Inclusion Criteria related to the WURSS-21 Symptom 
domain, the Baseline for Specific Quality of Life Questions (in appendix section 14.4) will be 
triggered for subject self-completion.  
This administration of the Specific QoL Questions at the Virtual Visit also develops the 
Baseline for eligible subjects. 
5.4.3 
Eligibility Review 
5.4.3.1 
Inclusion/Exclusion Criteria 
Inclusion and exclusion criteria as per Section 4.3 and 4.4 will be collected via pre-screening 
and screening surveys and confirmed during the virtual visit with a trained & delegated study 
team member.  
5.4.3.2 Medical History & Prior Medications 
A trained member of the study team will review the subject’s medical history and prior 
medications to confirm subject eligibility to participate in the study.  
Relevant medical and surgical history, including allergies or drug sensitivity can be 
documented by the investigator or designee in the medical history form. 
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Please refer to section 9 for further details on Adverse Event and Serious Adverse Event 
Monitoring. 
5.4.4 
Enrolled Subjects and Screen Failures 
An enrolled subject is one who has agreed to participate in the clinical study following 
completion of the eICF and who has directly and successfully met eligibility criteria to proceed 
beyond the screening visit. 
Screen failures are defined as subjects who consent to participate in the clinical study but do 
not meet study inclusion criteria.  
To ensure transparent reporting of screen failure subjects, a minimal set of screen failure 
information will include demography and screen failure details (e.g., withdrawal of consent, 
eligibility criteria, any protocol deviations and any adverse events). 
Individuals who do not meet the criteria for participation in this study (screen failure) will not 
be re-screened.  
5.4.5 
Randomization 
If the subject successfully meets eligibility criteria, the subject will be considered enrolled. At 
enrollment, the following activities will occur: 
● The subject will move forward to randomization into one of two study groups (on a 1:1 
allocation) as follows:  
○ Group 1: will be instructed to take the following per label instructions for up to 
8      days or until resolution of symptoms, whichever occurs first: 
 
Product 
Dose 
Robitussin Maximum Strength Cough and Chest Congestion DM Up to 20 ml* 
*Not to exceed 6 doses in any 24 hour period. 
○ Group 2: will be instructed to take the following per label instructions for up to 
8      days or until resolution of symptoms, whichever occurs first: 
 
Product 
Dose 
Robitussin Maximum Strength Cough and Chest Congestion DM Up to 20 ml* 
Robitussin Maximum Strength Nighttime Cough DM 
Up to 20 ml* 
*Not to exceed 4 doses of daytime + 1 dose of nighttime OR 3 doses of daytime 
+ 2 doses of nighttime in any 24 hour period.  
● Upon group allocation, study team will arrange delivery of the study product(s).  
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● Once the delivery is successfully received, the subject will confirm receipt and usability 
of the product(s) via an online questionnaire directly entered into the EDC platform.  
○ If unsuccessful (e.g. lost, damaged) study team will discuss with participant and 
arrange a new delivery if needed. 
During the screening visit, subjects will be provided with dosing instructions and training on 
how to complete the assessment, questionnaires, and eDiaries. Subjects will be reminded to 
reach out to the study team with any questions or concerns. 
5.5 
Treatment Period 
The number of days each subject will actively engage with the study will vary according to the 
resolution of their cough symptoms. Subjects will use the product(s) (as per label instructions) 
for up to 8      days unless they self-report that they are no longer seeking relief from their 
cough symptoms prior to that. If symptoms and subject reporting continues through Day 7     , 
subjects will complete the daily questionnaires for 7 days (Day 1 - Day 7). Subjects with cough 
symptoms resolved sufficiently to no longer warrant product use or those who determine they 
no longer wish to medicate for cough symptoms will complete daily forms from baseline 
through one day after the last dose of study product(s). This will complete their “study period”.  
The subject will receive links via text and email with instructions for completion of the study 
assessments. The subject will input their responses directly into the EDC platform during the 
study period: 
● Subjects will report any changes in health, use of concomitant medications, or non-drug 
treatments/procedures 
● Subjects will complete the WURSS-21 questionnaire, and specific QoL questions 
● Subjects will complete an eDiary to record product use each day including: 
○ product type taken 
○ number of doses 
● Subjects will self-report whether they are still seeking relief from their cough symptoms 
and answer end of the study questions prior to exiting the study. 
5.6 
End of Treatment Period 
Robitussin product(s) may be used for up to 8      days (Day 0 - Day 7). 
Subjects will have the option to discontinue treatment at their discretion. Subjects may choose 
to discontinue treatment if: 
● they feel that their symptoms do not warrant further use of the study product(s), or 
● their cough symptoms are considered resolved 
Subjects that continue to use the study product(s) will be prompted to discontinue treatment 
after 8      consecutive days of use and seek advice from their general physician for further 
assessment and treatment. 
Subjects will also be informed that the study will end on Day 7 (or the day after the last 
treatment, if earlier than Day 7     ), and will be asked to fill in an End of Study survey. 
Subjects will be informed that a Change in Health survey will be sent 2 days after their last 
study product dose (day 9 at latest) and will be asked to report any changes in their health post-
completion of the study. 
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5.7 
Study Conclusion 
The Study Conclusion page of the eCRF will be completed for all subjects by the study team.  
If a subject experiences any AEs Haleon will be notified. AEs may be marked as unresolved 
and local study PI will ask the subject to seek appropriate professional healthcare, if applicable. 
5.8 
Follow-Up Phone Call 
The study team will contact a subject to follow up on any reported ongoing AE/SAE post-study 
completion/withdrawal to ensure any issues are resolved as soon as possible. The study team 
must make every effort to regain contact with the subject (where possible, 3 contacts). 
Should the subject continue to be unreachable, the AE/SAE will be considered unresolved. 
Consistent with the treatment period, any reports that are collected on the WURSS-21 symptom 
domain assessment are not to be considered as AEs. 
Refer to section 9.8 Follow-up of AEs and SAEs for more information. 
6 
STUDY ASSESSMENTS 
Every effort should be made to ensure that protocol-required assessments and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it infeasible to complete 
an assessment.  When a protocol-required assessment cannot be performed, the investigator (or 
designee) will document the reason for the missed assessment as a protocol deviation and any 
corrective and preventative actions that he or she has taken to ensure that required processes 
are adhered to as soon as possible. The Sponsor must be informed of any missed assessments. 
6.1 
Outcome Assessments 
Assessments will be performed by delegated staff at the times, and in the order, defined in the 
Study Procedures section of this protocol.  
The primary objective of the study is to evaluate the over-time effects of two Robitussin 
Maximum Strength products on QoL factors and common cold symptoms among individuals 
experiencing cough associated with common cold, following up to 8      days of treatment using 
WURSS-21. 
Links will be sent to the subject daily for self-completion of the following quality of life tools 
from receipt of product to study conclusion. 
● WURSS-21 Questionnaire (in appendix section 14.3) 
● Additional QoL Questions (in appendix section 14.3) 
6.2 
Safety and Other Assessments 
The following safety assessments will be performed by appropriately trained staff/clinical 
examiners, at the times and in the order defined in the Study Procedures section of this protocol.   
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6.2.1 
Pregnancy Testing 
There is no pregnancy warning on labeling, a pregnancy test will not be required. 
Female subjects will provide verbal confirmation of pregnancy status at Screening (Virtual 
Visit) and will be asked to inform study staff immediately should this change at any point 
during the study. Female subjects who are pregnant or intending to become pregnant during 
the study (self-reported) will not participate further in the study. 
7 
STUDY PRODUCTS 
For the purposes of this study, per International Conference on Harmonization (ICH) 
guidelines, and Haleon policy, study intervention is defined as any investigational 
intervention(s), marketed product(s), placebo, or medical device(s) intended to be administered 
to a study participant according to the study protocol. This includes a product with a marketing 
authorization when used or assembled (formulated or packaged) in a way different from the 
approved form, or when used for an unapproved indication, or when used to gain further 
information about an approved use.  
As the study product(s) will be purchased from the local retailer, no study label will be required. 
7.1 
Study Product Supplies 
Each subject will receive sufficient study product(s) to cover usage during the treatment period 
of the study. The following study products will be supplied by the CRO’s preferred vendor 
(Table 7-1). Study product(s) usage instructions are consistent with the commercially available 
pack instructions. Subjects will not be required to return or destroy used/unused study products 
after treatment discontinuation, completion of study or withdrawal.  
Table 7-1 
Investigational/Study Product Supplies 
 
Group 1 
Group 2 
(Product 1 + Product2) 
Product Name 
Robitussin Maximum Strength 
Cough and Chest Congestion 
DM  
Robitussin Maximum Strength 
Cough and Chest Congestion 
DM  
 
Robitussin Maximum Strength 
Nighttime Cough DM  
Pack Design 
Labeled commercial pack 
Labeled commercial pack 
Dispensing Details 
Shipped to subject upon 
randomization 
Shipped to subject upon 
randomization 
Haleon formula codes: 
Dose and usage Instructions 
Up to 20 ml, not to exceed 6 
doses in any 24-hour period. 
 
Up to 20 ml per dose. 
Not to exceed 4 doses of 
daytime + 1 dose of nighttime 
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OR 3 doses of daytime + 2 
doses of nighttime in any 24-
hour period. 
Route of Administration 
Oral 
Oral 
Return Requirements 
All unused/used study products 
will not be returned 
All unused/used study products 
will not be returned 
*See dosing instructions in Section 5.4.5 
7.2 
Product Supplies, Product Storage, Accountability, Returns and 
Destruction 
Study products are to be dispensed only to subjects enrolled in the study in accordance with 
the protocol, by delegated study staff. Enrolled/randomized subjects will be informed on 
product usage and storage and what to do in the event of product loss when the products are 
first dispensed.  
All study products supplied are for use only in this clinical study and should not be used for 
any other purpose.  
Orders for study product(s) are to be placed immediately following randomization for delivery 
to subjects. Given this delivery model and the shelf stability of the product(s), a formal 
accountability form/record will not be maintained, however trained study staff will maintain 
an order and delivery tracker. 
At the end of the study, subjects may retain any remaining/unused study product(s). 
7.3 
Blinding and Randomization 
This is an open label study, and no blinding is required. 
Qualifying subjects will be centrally randomized into one of two study groups using a 1:1 
randomization list provided by Haleon Biostatistics. Subjects will be randomized into one of 
two study groups. Study Group 1 will take only the daytime Robitussin product and group 2 
will take both the daytime and the nighttime Robitussin products. Before the study is initiated, 
training and directions for the randomization will be provided to the investigator study team. 
Study products will be dispensed in sequential order as per the randomization schedule. Only 
subjects who meet the study inclusion criteria will be randomized to a study product. 
7.4 
Breaking the Blind 
Not applicable. 
8 
STATISTICAL CONSIDERATIONS AND DATA ANALYSES 
8.1 
Sample Size Determination 
Sufficient individuals (approximately 372) will be screened to enroll approximately 260 
eligible subjects assuming an estimated 23% drop out rate. It is believed that for this study, 200 
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completed subjects (100 per treatment group) are deemed sufficient to observe an improvement 
in the WURSS-21. 
8.2 
Populations for Analysis 
8.2.1 
Definitions of Analysis Populations 
The following four study populations will be used for statistical analysis: 
● The enrolled population will include all subjects who meet the inclusion/exclusion 
criteria. 
● The safety population will include all subjects who use study product at least once. The 
safety population will be used for analysis of the safety variables. 
● The modified Intent-To-Treat (mITT) population will include all subjects who use 
study product at least once and have data from at least one post baseline QoL 
questionnaire to support at least one of the primary endpoint assessments. QoL and 
ePRO data will be summarized using the mITT population only. 
● For the Exploratory Endpoint, the Non-Common-Cold-Med (NCCM) population will 
include all patients in the mITT population who have not used other medicinal products 
which might influence reported symptom severity. Reported concurrent medications 
will be assessed in a Blind Data Review (BDR) meeting to identify potentially 
interfering medications. 
8.3 
Statistical Analyses 
Additional details of the proposed statistical analysis will be documented in the statistical 
analysis plan (SAP), which will be written following finalization of the protocol and prior to 
study data analysis. All analyses will be carried out and reported without adjusting for multiple 
comparisons, reporting nominal p-values. 
Each of the treatment groups will be analyzed separately for all endpoints; there is no 
comparison between the study groups (daytime product only and daytime/nighttime product 
combination). 
Baseline WURSS-21 and the Specific QoL questions are completed at the Virtual Visit, prior 
to study product(s) shipment to the subject. 
8.3.1 
Exclusion of Data from Analysis 
Exclusion of any data from the analyses will be determined during a BDR meeting prior to 
database lock. Any reasons for exclusion from an analysis population will be listed, if 
applicable. 
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8.3.2 
Primary Endpoint Analysis(es)  
For the primary objective, measurements of health related QoL indicators and cold symptoms 
will be evaluated using daily WURSS-21 scores (total scores, total QoL domains scores, total 
symptom domains scores, and single symptom and QoL domains scores) change from baseline 
to each treatment day to determine the effectiveness of the two treatment groups (Daytime, 
Daytime+Nighttime).  
Change from Baseline in mean WURSS-21 scores to each treatment day will be summarized 
and analyzed using a mixed-effects model for repeated measures (MMRM) with treatment, 
treatment day as a discrete variable, and applicable baseline WURSS-21 scores as fixed effect 
and a random intercept for each subject. Estimated marginal mean differences between baseline 
and each treatment day will be reported by treatment group including the mean difference on 
the original scale, standardized effect size including 95% confidence intervals (CI), and the 
respective p-value. The distribution of each outcome is assessed using Q-Q-plots by treatment 
group. In case of apparent deviations from the normal distribution, the changes from baseline 
are assessed using a Wilcoxon signed-rank test. 
8.3.3 
Secondary Endpoint Analysis(es) 
For the secondary objective, measurements of health related QoL indicators will be evaluated 
using the specific QoL scores and categorized QoL scores change from baseline to each 
treatment day to determine the effectiveness of the two treatment groups (Daytime, 
Daytime+Nighttime).  
Change from baseline in mean specific QoL scores and categorized QoL scores to each 
treatment day will be summarized and analyzed using a mixed-effects model for repeated 
measures (MMRM) with treatment, treatment day, as a discrete variable, and applicable 
baseline specific QoL scores or categorized QoL scores as fixed effect and a random intercept 
for each subject. Estimated marginal mean differences between baseline and each treatment 
day will be reported by treatment group including the mean difference on the original scale, 
standardized effect size including 95% confidence intervals (CI), and the respective p-value. 
The distribution of each outcome is assessed using Q-Q-plots by treatment group. In case of 
apparent deviations from the normal distribution, the changes from baseline are assessed using 
a Wilcoxon signed-rank test. 
The QoL scores (sum of individual questions per category) will be categorized as below: 
1. Sleep Quality 
○ Sleep Well – WURSS-21 Q13 
○ Falling asleep – QoL Q4 
○ Sleep through the night – QoL Q5 
2. Social Activities 
○ Interact with others – WURSS-21 Q19 
○ Less comfortable in social activities – QoL Q1 
○ Self-conscious around others – QoL Q2 
○ Coughing in public – QoL Q3 
3. Physical Activities 
○ Breathe easily - WURSS-21 Q14 
○ Walk, climb stairs, exercise - WURSS-21 Q15 
○ Accomplish daily activities - WURSS-21 Q16 
4. Vitality 
○ Energy – QoL Q6 
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○ Motivation – QoL Q7 
○ Feel tired - WURSS-21 Q11 
8.3.4 
Safety Analysis(es) 
All AEs will be coded using MedDRA. AEs will be categorized as related, probable, unlikely, 
or unrelated by 
 prior to database lock. The number of AEs/SAEs and the number 
of subjects with AEs/SAEs will be listed and tabulated. 
8.3.5 
Exploratory Analysis(es) 
For the exploratory objective, the NCCM population (defined in section 8.2.1) will be used to 
analyze the Primary and Secondary endpoints. 
Additional exploratory analysis may be conducted as defined in the SAP. 
8.3.6 
Demographic and Baseline Characteristics 
For each of the treatment groups, age and other continuous demographic and baseline variables 
will be summarized using descriptive statistics such as mean, range, median and standard 
deviation. Gender and other categorical demographic and baseline variables will be 
summarized using frequency counts and percentages for the safety and mITT populations. 
8.3.7 
Study Product Compliance and Use of Other Therapies 
8.3.7.1 
Study Product Compliance 
Study product compliance will be tabulated and summarized for the safety population. 
Summaries will include a simple yes/no frequency (and percent) count at each timepoint. 
8.3.7.2 
Prior and Concomitant Medications 
Prior medication use will be assessed during the Screening & Baseline Virtual visit. Prior 
medications/non-drug therapies and concomitant medications/significant non-drug therapies 
used prior to treatment initiation and in the treatment phase will be listed, including the 
frequency within each group, for the Safety population. 
8.3.8 
Handling of Dropouts and Missing Data  
Missing values will not be imputed. 
9 
ADVERSE EVENT (AE) AND SERIOUS AE (SAE) 
Adverse events can be reported / recorded by any member of the trial team. The investigator 
and their authorized safety designees are responsible for detecting, documenting and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up AEs 
that are serious, considered related to study product, a study procedure or study participation, 
or that caused the subject to discontinue use of a study product or study participation.  
Any reports that are collected on the WURSS-21 symptom domain assessment are not to be 
considered as AEs. 
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All Adverse Events and Serious Adverse Events will be managed in line with the protocol and 
in line with the Site and Safety Management Plan.  
9.1 
Definition of an Adverse Event (AE) 
An AE is any untoward medical occurrence in a clinical study subject, temporally associated 
with the use of a study product including an acclimatization product whether or not considered 
related to the study product, including an acclimatization product Note: An AE can therefore 
be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, 
or disease (new or exacerbated) temporally associated with the use of a study product including 
an acclimatization product (or medical device). 
Events Meeting the AE Definition:  
● Any abnormal laboratory test results (hematology, clinical chemistry or urinalysis) or 
other safety assessments (e.g., electrocardiogram, radiological scans, vital sign 
measurements), including those that worsen from Baseline, considered clinically 
significant in the medical and scientific judgment of the investigator (i.e., not related to 
progression of underlying disease). 
● Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
● New conditions detected or diagnosed after study product administration even though 
it may have been present before the start of the study. 
● Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
● Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
product or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
● ‘Lack of efficacy’ or ‘failure of expected pharmacological action’ per se will not be 
reported as an AE. Such instances will be captured in the efficacy assessments. 
However, the signs, symptoms and/or clinical sequelae resulting from lack of efficacy 
will be reported as an AE if they fulfill the definition of an AE. 
Events NOT meeting the AE definition: 
● Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s condition. 
● The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s 
condition. 
● A medical or surgical procedure (e.g., endoscopy, appendectomy) is not an AE. The 
condition that leads to the procedure is an AE (e.g., appendicitis). Planned medical or 
surgical procedures for preexisting illnesses are not an adverse event. 
● Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
9.2 
Definition of a Serious Adverse Event 
An SAE is a particular category of AE where the outcome is serious. If an event is not an AE 
per definition above, then it cannot be an SAE, even if serious conditions are met (e.g., 
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hospitalization for signs/symptoms of the disease under study, death due to progression of 
disease). A serious adverse event is any untoward medical occurrence at any dose that: 
● Results in death 
● Is life‑threatening 
○ The term 'life-threatening' in the definition of 'serious' refers to an event in 
which the subject was at risk of death at the time of the event. It does not refer 
to an event, which hypothetically might have caused death, if it were more 
severe. 
● Requires inpatient hospitalization or prolongation of existing hospitalization 
○ In general, hospitalization signifies that the subject has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolonged hospitalization or fulfills 
any other serious criteria, the event is serious. When in doubt as to whether 
‘hospitalization’ occurred, or was necessary, the AE should be considered 
serious. 
○ Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline more than would be expected under the normal 
progression of the disease not considered an AE. 
● Results in persistent or significant disability/incapacity 
○ The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions. 
○ This definition is not intended to include experiences of relatively minor 
medical significance such as uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may 
interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
● Results in congenital anomaly/birth defect 
● Other situations: 
○ Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the subject or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious. 
○ Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization, or development 
of drug dependency or drug abuse. 
Note: Classification of an AE as ‘serious’ is based on the outcome of the event and is a factor 
in determining reporting requirements. 
Events exempt from immediate reporting as SAEs 
Hospitalization for a pre-existing condition, including elective procedures planned prior to trial 
entry, which has not worsened, does not constitute an SAE. 
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9.3 
Time Period and Frequency for Collecting AE and SAE 
Information 
All AEs, and therefore all SAEs (except from those exempt from recording, as described in 
section 9.1 and section 9.2) will be collected from immediately after a subject is randomized 
within the trial and until 2 days following the last administration of study product.  
A change in health survey will be released to subjects 2 days after their last study product(s) 
dose. If a subject reports a change in health, a member of the study team will reach out to record 
the relevant details. 
Medical occurrences that began before randomisation will be recorded in the Medical 
History/Current Medical Conditions section of the Electronic Case Report Form (eCRF), not 
the AE section. 
Details recorded by the subject that meet the definition of a serious AE must be discussed with 
the subjects and transcribed into the SAE section of the eCRF  
All SAEs will be recorded and reported to the sponsor or designee immediately, and under no 
circumstance should this exceed 24 hours. The investigator will submit updated SAE data to 
the sponsor within 24 hours of it being available. 
9.4 
Reporting Procedures 
The investigator and study delegated designees are responsible for detecting, documenting and 
reporting events that meet the definition of an AE and remain responsible for following up AEs 
that are serious, considered related to study product, a study procedure or study participation, 
or that caused the subject to discontinue use of study product or study participation, until 
stabilization, resolution, trial completion or loss to follow up, whichever comes sooner. 
The investigator and their authorized trial designees are to report all AEs at study visits and all 
AEs spontaneously reported by study subjects. 
Study subjects will be questioned about AEs. Care will be taken not to introduce bias when 
questioning a subject about any changes in their health. Open-ended and non-leading verbal 
questioning should be used. 
AEs spontaneously reported by study subjects and those elicited by asking subjects to respond 
to non-leading questions (such as ‘how do you feel?’) will be assessed, recorded in the eCRF 
and reported, as appropriate. 
Each AE is to be assessed to determine if it meets the criteria for a SAE. If an SAE occurs, 
expedited reporting will follow local and international regulations, as appropriate. 
When an AE occurs, it is the responsibility of the investigator or their medically qualified 
designee to assess the severity of the event, which may require a review of additional 
documentation (e.g., hospital progress notes, laboratory and diagnostics reports) related to the 
event. The investigator or study staff will then record all relevant information relating to the 
event in the SAE section of the eCRF. In addition, all details relating to an SAE will be recorded 
electronically within Citrus using the SAE eCRF provided. 
It is not acceptable for the investigator or their authorized safety designee to send photocopies 
of a subject’s medical records to the sponsor in lieu of completion of the AE section of the 
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eCRF/paper SAE form. There may be instances when copies of medical records for certain 
cases are requested by the sponsor.  In this instance, all subject identifiers, except for the subject 
number, will be redacted on the copies of the medical records prior to submission to the 
sponsor. 
The investigator or their medically qualified designee will attempt to establish a diagnosis 
based on signs, symptoms and/or other available clinical information related to the event. The 
diagnosis will be documented as the AE/SAE, where known, and not the individual 
signs/symptoms (e.g., upper respiratory tract infection or seasonal allergy, not ‘runny nose’). 
9.5 
Reporting an AE 
AEs will be reported by the investigator, their authorized trial designee or investigator staff in 
the AE section of the eCRF.  These are collected throughout the study at each follow-up visit. 
Additionally, the subject will have the option to report any AEs to the study staff at any point 
during the study. Where an SAE is recorded the electronic SAE form should be utilized and 
reported within 24 hours of awareness. AEs/SAEs will be recorded based on information from 
the participant. The event terms will then be coded by a qualified member of the research team 
(see Section 11.2 for further details).  
9.6 
Reporting an SAE 
In addition to recording the details of each SAE in the AE section of the eCRF, an SAE form 
should be completed, as fully as possible. All SAE reporting will utilize the eCRF in Citrus. 
It is essential to record the following information for each SAE: 
● Protocol and subject identifiers 
● Subject demography 
● Description of event with diagnosis, if available 
● Investigator opinion of relationship to study product (or study procedure) 
● Criterion for seriousness. 
The following are desirable and are of particular relevance for investigator and sponsor 
assessment of the SAE report: 
● Date of onset of SAE 
● Date SAE stopped, if relevant 
● Study product start date 
● Study product end date, if relevant 
● Action taken in relation to study product 
● Outcome, if known 
The SAE form, completed as fully as possible, must be exported from Citrus, e-mailed to the 
sponsor’s Case Management Group mailbox 
, with the 
appropriate sponsor Study Manager in copy, with the study number and subject number in the 
subject line of the email immediately after investigator staff learn of the event, and under 
no circumstances should this exceed 24 hours. The investigator will submit any updated SAE 
data to the sponsor, immediately once it becomes available, and under no circumstance 
should this exceed 24 hours of it being available. 
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The initial report will be followed up with more information as relevant, or as requested by the 
sponsor’s Study Manager. The sponsor’s Study Manager will be responsible for forwarding 
the SAE form to other sponsor personnel as appropriate. 
9.7 
Evaluating AEs 
Assessment of Intensity 
The investigator or their medically qualified designee will make an assessment of intensity for 
each AE reported during the study and will assign it to one of the following categories: 
● Mild:  An event that is easily tolerated by the subject, causing minimal discomfort and 
not interfering with everyday activities. 
● Moderate:  An event that is sufficiently discomforting to interfere with normal 
everyday activities 
● Severe:  An event that prevents normal everyday activities. 
Note: An AE assessed as ‘severe’ should not be confused with an SAE. ‘Severe’ is a category 
utilized for rating the intensity of an event. Both non-serious AEs and SAEs can be assessed as 
severe, e.g., a headache may be severe (significantly interferes with the subject's usual function) 
but would not be classified as serious unless it met one of the criteria for SAEs listed in Section 
9.2. An event is defined as ‘serious’ when it meets at least one of the pre-defined outcomes 
described in the definition of an SAE (section 9.2), not when it is rated as ‘severe’. 
Assessment of Causality 
For each AE (non-serious and serious), the investigator or their medically qualified designee 
must provide an assessment of causality in the AE section of the eCRF and on the SAE form 
(as appropriate, subject to classification of the AE). Causality is one of the criteria used to 
determine regulatory reporting requirements. 
A ‘reasonable possibility’ of a relationship conveys there are facts (evidence) and/or arguments 
to suggest a causal relationship, rather than a relationship cannot be ruled out. Generally, the 
facts (evidence) or arguments to suggest a causal relationship should be provided in the 
AE/SAE report. 
The investigator or their medically qualified designee will use clinical judgment to determine 
causality and will also consult the Product Label, as appropriate, when making their 
assessment. Alternative causes, such as underlying disease(s), concomitant therapy, other risk 
factors and the temporal relationship of the event to study product use will be considered and 
investigated. 
Documentation of the (S)AE assessment will be recorded in the trial database, including the 
assessment of causality.Where applicable, the investigator or their medically qualified designee 
must document in the medical notes they have reviewed the AE/SAE and provided an 
assessment of causality. 
There may be situations, when an SAE has occurred, where the investigator or their medically 
qualified designee has minimal information to include in the initial SAE report. However, it is 
very important that the investigator or their medically qualified designee always makes 
an assessment of causality for every event prior to initial transmission of the SAE data to 
the sponsor. The investigator may change their opinion of causality, in light of follow-up 
information, and send an SAE follow-up report with an updated causality assessment. 
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9.8 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator or their authorized safety designee is required 
to proactively follow up all ongoing serious and severe AE with each subject and provide 
further information on the subject’s condition, as available. 
All severe AEs (non-serious and serious) should be followed until resolution, until the 
condition stabilizes, until the event is otherwise explained or until the subject is lost to follow-
up.  
The investigator or their medically qualified designee is obligated to perform or arrange for the 
conduct of supplemental measurements and/or evaluations as may be indicated (or as requested 
by the sponsor) to elucidate as fully as possible the nature and/or causality of the AE/SAE. 
These may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other healthcare professionals. 
New or updated information will be recorded in the AE section of the eCRF and on the SAE 
form (as appropriate, subject to classification of the AE). The investigator or their authorized 
safety designee will submit any updated SAE data to the sponsor within 24 hours of receipt of 
the information. 
The investigator and their authorized safety designees are not obligated to actively seek AEs 
or SAEs after the conclusion of study participation. However, if the investigator or their 
medically qualified designee learns of an SAE, including a death, at any time after a subject 
has been discharged from the study, and they consider the event to be reasonably related to 
study product or study participation, they must promptly notify the sponsor by emailing the 
information 
to 
the 
sponsor’s 
Case 
Management 
Group 
mailbox 
, with the appropriate sponsor Study Manager in copy. 
The investigator or their authorized trial designee will submit any updated SAE data to the 
sponsor within the designated reporting time frames. 
9.9 
Withdrawal Due to an Adverse Event 
Withdrawal due to AEs should be distinguished from withdrawal due to other causes, according 
to the definition of an AE provided (Section 9.1) and recorded in the withdrawal AE section of 
the eCRF. 
When a subject withdraws due to an SAE, the SAE must be reported in accordance with the 
reporting requirements defined in this protocol. 
9.10 
Regulatory Reporting Requirements for SAEs 
The sponsor has a legal responsibility to notify, as appropriate, the local regulatory authority 
and other regulatory authorities about the safety of a product under clinical investigation.  
Prompt notification of SAEs by the investigator to the sponsor is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects are met. 
The sponsor will comply with country specific regulatory requirements relating to safety 
reporting to the regulatory authority, the Institutional Review Board (IRB) and the investigator. 
Investigator safety reports must be prepared for suspected Unexpected Serious Related Event 
(USRE) according to local regulatory requirements and sponsor policy, and forwarded to the 
investigator, as appropriate. 
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If the investigator receives an investigator safety report describing a SAE or other specific 
safety information (e.g., a summary or listing of SAEs) from the sponsor, they will review it, 
file it with other safety information (e.g., the IB) in the investigator site file and notify the REC, 
if appropriate, according to local requirements. 
9.11 
Pregnancy 
9.11.1 
Time Period for Collecting Pregnancy Information 
Pregnancy information will be collected on all pregnancies reported while a female subject is 
participating in the study from the date/time of signing the informed consent until 5 days after 
the last administration of the study product. 
9.11.2 
Action to be Taken if Pregnancy Occurs 
The investigator or their authorized trial designee will record pregnancy information on the 
appropriate 
eCRF 
and 
e-mail 
it 
to 
the 
Case 
Management 
Group 
mailbox 
within 24 hours, with the appropriate sponsor Study 
Manager in copy. Original completed pregnancy information forms will be retained in the 
investigator site file. 
The female subject will not be followed to determine the outcome of the pregnancy. Any female 
subject who becomes pregnant while participating will be withdrawn.  
10 
DISCONTINUATION OF STUDY INTERVENTION AND 
SUBJECT DISCONTINUATION/WITHDRAWAL 
If a subject is discontinued early from the study product (Section 10.1) or discontinued or 
prematurely withdraws from the study (Section 10.1.1), the reason(s) for intervention 
discontinuation or withdrawal and the associated date must be documented in the relevant 
section(s) of the eCRF. If a subject is discontinued early from the study product, the subject 
should stay in the study and complete the remaining assessments unless they need to be 
withdrawn (see Section 10.1.1). 
10.1 
Discontinuation of Study Product  
A subject may be discontinued from the study product at any time whilst still in the study at 
the discretion of the investigator related to safety, subject consent or a potential worsening of 
the risk / benefit assessment from the subject of remaining on the intervention for the following 
reasons: 
● Adverse Event 
● Lack of efficacy from the intervention 
● Subject request 
● Subject to be withdrawn from the study (see Section 10.1.1)  
10.1.1 
Subject Discontinuation/Withdrawal  
A subject may withdraw from the study at any time at his or her own request or may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral 
reasons, or the inability of the subject to comply with the protocol-required schedule of study 
visits or procedures.   
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Inclusion/Exclusion criteria are assessed at Baseline. Any participant who develops 
exclusionary symptoms during the course of the trial can be withdrawn at the discretion of the 
investigator. 
The following circumstances require discontinuation of study product and/or premature subject 
withdrawal: 
● Protocol violation that may impact the subject’s safety 
● Withdrawal of informed consent 
● Subject lost to follow-up  
● Unblinding of the subject  
● Pregnancy 
● Investigator withdrawal due to worsening severity of health condition 
If the subject withdraws from the study and withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
10.1.2 
Lost to Follow up 
If a subject fails to complete two consecutive days of e-diaries, the investigator or designee 
must make every effort to regain contact with the subject (where possible, 3 telephone calls or 
emails or local equivalent methods) and counsel the subject on the importance of maintaining 
the assigned activity schedule and ascertain whether the subject wishes to and/or should 
continue in the study. 
A subject will be considered lost to follow up and withdrawn from the study if he or she 
repeatedly fails to complete scheduled activities and is unable to be contacted following the 3 
contact attempts by the study team.  
If contact is made with the subject, the investigator should inquire about the reason for 
withdrawal and if appropriate request that the subject attend a final virtual visit and follow-up 
with the subject regarding any unresolved adverse events (AEs). 
11 
DATA MANAGEMENT 
11.1 
Case Report Form 
An eCRF is an electronic document designed to record the protocol required information to be 
reported to the sponsor on each trial subject. 
For each subject who has given informed consent the eCRF must be completed and signed by 
the Principal Investigator (or authorized designee) to certify that the data are complete and 
correct.  The investigator must maintain accurate documentation (source data) that supports the 
information entered in the eCRF. 
11.2 
Data Handling 
Documentation of all data management activities should allow step-by-step retrospective 
assessment of data quality and study performance.  
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Any changes or corrections to data will be performed in the Electronic Data Capture (EDC) 
System, and it will include rationale for changes. The EDC system has an audit trail, which 
will provide a complete record of the changes and corrections endorsed by the Investigator. 
Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) 
and any concomitant medications terms (if applicable) using an internal validated medication 
dictionary. The MedDRA dictionary version will be documented within the Data Management 
Plan (DMP). 
11.2.1 
Data Queries 
Programmed edit checks will be generated automatically, as the data are being entered into the 
system. Reports and listings on the CRF data will also be run, in addition to the queries already 
programmed and generated by the system, to raise manual queries as needed for site 
clarification or correction. The Clinical Dictionary Development and Management Group will 
raise queries as needed on safety data to code the terms (AEs and Drugs or concomitant 
medication) appropriately.  
The study monitor will perform ongoing review of the CRFs in accordance with the monitoring 
plan, to confirm that data entered into the CRF by authorized site personnel are accurate and 
complete; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements. 
Any queries will be generated in the EDC System to the Investigator or designee, enabling the 
errors to be addressed in parallel with Data Management review. The study monitor can also 
run reports and listings on the CRFs, to raise manual queries as needed for site clarification or 
correction. 
11.3 
Processing Patient Reported Outcomes and Data Collection 
from Internet of Medical Things 
Electronic Patient reported outcome (ePRO) that are measured by Internet of Medical Things 
(IoMT) devices (i.e., wearables, patches, sensors, and mobile data collection units such as 
smartphones and tablets) will be transferred in the protocol-specified aggregated and/or raw 
form electronically to Haleon or Third-party data management vendor. 
All ePRO source data should be reviewed by the study staff and the study monitor to ensure 
accurate transcription of data and that any potential AEs or concomitant medications reported 
on these documents are discussed with the subject and transcribed accurately to the eCRF 
and/or DMS.  ePROs that are classed as source data will be retained by the investigator and 
true/certified copies may be sent to a designated vendor or Haleon as required. Any AEs or 
concomitant medications collected as ePRO will be reviewed and transcribed to the eCRF by 
the site. 
To protect the privacy of subjects, no Personal Information (PI) (including the subject's name 
or initials or birth date) is to be recorded on any PRO/ePRO/IoMT Devices Data that will be 
forwarded to Haleon or Third-Party Vendor. 
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12 
STUDY GOVERNANCE CONSIDERATIONS 
Electronic Patient reported outcome (ePRO) that are measured by  Internet of Medical Things 
(IoMT) devices (i.e., wearables, patches, sensors, and mobile data collection units such as 
smartphones and tablets) will be transferred in the protocol-specified aggregated and/or raw 
form electronically to Haleon or Third-party DM vendor. 
All ePRO source data should be reviewed by the study staff and the study monitor to ensure 
accurate transcription of data and that any potential AEs or concomitant medications reported 
on these documents are discussed with the subject and transcribed accurately to the eCRF 
and/or DMS.  ePROs that are classed as source data will be retained by the investigator and 
true/certified copies may be sent to a designated vendor or Haleon as required. Any AEs or 
concomitant medications collected as ePRO will be reviewed and transcribed to the eCRF by 
the site. 
To protect the privacy of subjects, no Personal Information (PI) (including the subject's name 
or initials or birth date) is to be recorded on any PRO/ePRO/IoMT Devices Data that will be 
forwarded to Haleon or Third-Party Vendor. 
12.1 
Quality Control 
When reviewing data collection procedures, the discussion will include identification, 
agreement, and documentation of data items for which the eCRF will serve as the source 
document. 
will monitor the study data to verify that the: 
● Data are authentic, accurate, and complete. 
● Safety and rights of subjects are being protected. 
● Study is conducted in accordance with the currently approved protocol and any other 
study agreements, GCP, and all applicable regulatory requirements. 
12.2 
Quality Assurance 
To ensure compliance with GCP and all applicable regulatory requirements, Haleon may 
conduct a quality assurance assessment and/or audit of the site records, and the regulatory 
agencies may conduct a regulatory inspection at any time during or after completion of the 
study. 
In the event of an assessment, audit, or inspection, 
 must agree to grant the 
advisor(s), auditor(s), and inspector(s) direct access to all relevant documents and to allocate 
their time and the time of their staff to discuss the conduct of the study, any findings/relevant 
issues and to implement any corrective and/or preventative actions to address any 
findings/issues identified. 
 will notify Haleon or its agents immediately of any regulatory inspection 
notification in relation to the study. The sponsor will be available to help
prepare 
for an inspection.  
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12.3 
Regulatory and Ethical Considerations 
12.4 
Institutional Review Board/ Ethics Committee  
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, informed consent document, safety statement (including any updates) 
and other relevant documents, e.g. recruitment advertisements, if applicable, from the IRB/EC.  
All correspondence with the IRB/EC should be retained in the investigator file.  Copies of 
IRB/EC approvals should be forwarded to Haleon prior to the initiation of the study, and also 
when subsequent amendments to the protocol are made. 
The only circumstance in which an amendment may be initiated prior to IRB/EC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects.  In that 
event, the investigator must notify the IRB/EC and Haleon in writing immediately after the 
implementation. 
12.5 
Ethical Conduct of the Study 
The study will be conducted in accordance with the protocol and legal and regulatory 
requirements, as well as the general principles set forth in the International Ethical Guidelines 
for Biomedical Research Involving Human Subjects (Council for International Organizations 
of Medical Sciences 2002), International Ethical Guidelines for Health-Related Research 
Involving Humans (Council for International Organizations of Medical Sciences, 2016), 
guidelines for GCP (ICH 1996 and revision 2), and the ethical principles that have their origin 
in the Declaration of Helsinki (World Medical Association 2013).  
In addition, the study will be conducted in accordance with the protocol, the ICH guideline on 
GCP, and applicable local regulatory requirements and laws. 
12.6 
Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject names 
or other identifiable data in any reports, publications, or other disclosures, except where 
required by laws.  
When study data are compiled for transfer to Haleon and other authorized parties, subject 
names, addresses, and other identifiable data will be replaced by numerical codes based on a 
numbering system provided by Haleon in order to de-identify study subjects.   
The study site will maintain a confidential list of subjects who participated in the study, linking 
each subject’s numerical code to his or her actual identity.  In case of data transfer, Haleon will 
maintain high standards of confidentiality and protection of subjects’ personal data consistent 
with applicable privacy laws. 
12.7 
Subject Recruitment 
Advertisements approved by IRBs and investigator databases may be used as recruitment 
procedures. Use of an IRB approved, generic, prescreening questionnaire to assess basic 
subject characteristics to determine general eligibility for this study is allowed. 
Haleon will have an opportunity to review and approve the content of any study recruitment 
materials directed to potential study subjects before such materials are used. 
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12.8 
Reporting of Safety Issues and Serious Breaches of the Protocol 
or ICH GCP 
Within Haleon a serious breach is defined as a breach likely to affect to a significant degree 
the safety and rights of a subject or the reliability and robustness of the data generated in Haleon 
sponsored human subject research studies. 
In the event of any prohibition or restriction imposed (i.e., clinical hold) by an applicable 
competent authority in any area of the world, or if 
is aware of any new 
information that might influence the evaluation of the benefits and risks of the investigational 
product, Haleon should be informed immediately. 
In addition,
will inform Haleon immediately of any urgent safety measures taken 
by the investigator/designee to protect the study subjects against any immediate hazard, and of 
any serious breaches of this protocol or of ICH GCP that the investigator/designee becomes 
aware of. 
12.9 
Oversight Committees 
Due to the low-risk nature of the trial, no oversight committees will be utilized. Monitoring 
will occur as per the study-specific risk-based monitoring plan. 
12.10 
Disclosure and Publication Policy 
Study information from this protocol may be posted on publicly available clinical trial registers 
before enrollment of subjects begins in accordance with applicable Haleon policies. 
Haleon intends to make anonymized subject-level data from this study available to external 
researchers for scientific analyses or to conduct further research that can help advance medical 
science. This helps ensure the data provided by study participants are used to maximum effect 
in the creation of knowledge and understanding. 
The procedures and timing for public disclosure of the results summary and for development 
of a manuscript for publication will be in accordance with sponsor policy and as per the country 
specific requirements for disclosure. 
12.11 
Provision of Study Results to Investigators 
Where required by applicable regulatory requirements, a local PI signatory will be identified 
for the approval of the clinical study report. The local PI will be provided reasonable access to 
statistical tables, figures, and relevant reports and will have the opportunity to review the 
complete study results at a Haleon site or other mutually agreeable location. 
Haleon will also provide the local PI with the full summary of the study results. The local PI is 
encouraged to share the summary results with the study subjects, as appropriate.  
The procedures and timing for public disclosure of the results summary and for development 
of a manuscript for publication will be in accordance with Haleon Policy. 
A manuscript will be progressed for publication in the scientific literature if the results provide 
important scientific or medical knowledge. 
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12.12 
Records Retention 
Following closure of the study, the investigator must maintain all site study records (except for 
those required by local regulations to be maintained elsewhere), in a safe and secure location.   
Where permitted by local laws/regulations or institutional policy, some or all of these records 
can be maintained in a format other than hard copy (e.g., microfiche, scanned, electronic); 
however, caution needs to be exercised before such action is taken.  
The investigator must notify Haleon of any changes in the archival arrangements, including, 
but not limited to, archival at an off-site facility or transfer of ownership of the records in the 
event the investigator is no longer associated with the site. 
12.13 
Conditions for Terminating the Study 
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the IRB, or study product safety problems, or at the discretion of Haleon. 
If a study is prematurely terminated, Haleon will promptly notify 
 After 
notification,
must promptly contact all participating subjects and should assure 
appropriate therapy/ follow-up for the subjects. As directed by Haleon, all study materials must 
be collected and all eCRF’s completed to the greatest extent possible. Where required by the 
applicable regulatory requirements, Haleon should inform the regulatory authority(ies) and the 
investigator should promptly inform the IRB and provide the IRB a detailed written explanation 
of the termination or suspension. 
If the IRB terminates or suspends its approval/favorable opinion of a trial, the local PI or 
designee should promptly notify the Haleon and provide Haleon with a detailed written 
explanation of the termination or suspension. 
Upon completion or premature discontinuation of the study, the Haleon monitor will conduct 
site closure activities with 
 as appropriate, in accordance with applicable 
regulations including GCP, and Haleon Standard Operating Procedures. 
 
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13 
REFERENCES 
[Hemila H (2017)] Vitamin C and Infections. Nutrients; 9(4). 
[Passioti M, Maggina P, Megremis S, et al. (2014)] The common cold: potential for future 
prevention or cure. Curr Allergy Asthma Rep; 14(2): 413. 
[Stein RA (2017)] Hopes and challenges for the common cold. Int J Clin Pract; 71(2). 
Eccles R, Van Cauwenberge P, Tetzloff W, Borum P. A clinical study to evaluate the efficacy 
of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated 
with upper respiratory tract infection. J Pharm Pharmacol. 1995;47(12A):990-993. 
doi:10.1111/j.2042-7158.1995.tb03283.x 
Parvez L, Vaidya M, Sakhardande A, Subburaj S, Rajagopalan TG. Evaluation of antitussive 
agents in man. Pulmonary Pharmacology 1996;9(5-6):299-308. 
Pavesi L, Subburaj S, Porter-Shaw K. Application and validation of a computerized cough 
acquisition system for objective monitoring of acute cough: a meta-analysis. Chest 
2001;120:1121-8. 
Robinson RE, Cummings WB, DeDenbaugh ER. EDectiveness of guaifenesin as an 
expectorant: a cooperative double-blind study. Current Therapeutic Research 1977;22(2):284-
96. 
 
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14 
APPENDICES 
14.1 
Schedule of Assessments Schematic 
Pre-screening, Screening & Baseline (continues on next page) 
 
 
 
 
 
 
 
 
 
 
 
 
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Screening & Baseline (continued from previous page, continues on next page) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Screening & Baseline (continued from previous page), Active Trial (continues on next page) 
 
 
 
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Active Trial (continued from previous page), Active Trial (continues on next page) 
 
 
 
 
 
 
 
 
 
 
 
 
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Active Trial (continued from previous page), End of Study 
 
 
 
 
 
 
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14.2 
Study Assessments 
14.2.1 
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) 
 
 
14.2.2 
Specific Quality of Life (QoL)Questions 
14.2.2.1 Baseline Questions (pre-treatment): 
Please complete this questionnaire prior to your first dose of the study product(s). 
Considering the past 24 hours, please read each question and choose the answer that best 
reflects your experience with Robitussin use and your cough/cold: 
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1. Is your cough/cold making you less comfortable participating in social activities? 
2. Is your cough making you self-conscious around people? 
3. Are you worried about coughing in public? 
4. Is your cough/cold making it more difficult for you to fall asleep? 
5. Is your cough/cold making it more difficult to sleep through the night? 
6. Is your cough/cold making you less energetic than usual? 
7. Is your cough/cold making you less motivated than usual? 
14.2.2.2 Post treatment Questions (asked every day in the morning): 
Considering the past 24 hours, please read each question and choose the answer that best 
reflects your experience with Robitussin use and your cough/cold: 
 
1. After using Robitussin, is your cough/cold making you less comfortable participating 
in social activities? 
2. After using Robitussin, is your cough making you self-conscious around people? 
3. After using Robitussin, are you worried about coughing in public? 
4. After using Robitussin, is your cough/cold making it more difficult to fall asleep? 
5. After using Robitussin, is your cough/cold making it more difficult to sleep through the 
night? 
6. After using Robitussin, is your cough/cold making you less energetic than usual? 
7. After using Robitussin, is your cough/cold making you less motivated than usual? 
 
 
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15 
ABBREVIATIONS 
The following is a list of abbreviations that are used in the protocol. 
Table 15-1 
Abbreviations 
Abbreviation 
Term 
AE 
Adverse Event 
BDR 
Blinded Data Review 
COVID-19 
2019 Novel Coronavirus 
CRO 
Clinical Research Organization 
DM 
Data Manager 
DM HBr 
Dextromethorphan  
DMP 
Data Management Plan 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
eDiary 
Electronic Diary 
e.g. 
exempli gratia (for example)  
eICF 
Electronic Informed Consent Form 
ePRO 
Electronic Patient-Reported Outcome 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
H1 
Histamine-1 
ICH 
International Conference on Harmonization 
ID 
Identification 
IOMT 
Internet of Medical Things  
IRB 
Insitutional Review Board 
ITT 
Intent to Treat 
MAOI 
Monoamine Oxidase Inhibitors  
MD 
Medical Doctor 
MedDRA 
Medical Dictionary for Regulatory  Activities 
mg 
Miligranms 
mITT 
Modified Intent to Treat 
ml 
Mililiters 
MMRM 
Mixed Model with Repeated Mearures 
N/A 
Not Applicable 
NCCM 
Non-Common-Cold-Med 
OTC 
Over the Counter 
PDF 
Portable Document Format 
PI 
Personal Information 
PI 
Principal Investigator 
PRO 
Patient Reported Outcome 
QoL 
Quality of Life 
RCT 
Randomized-controlled Trial 
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Abbreviation 
Term 
RWD 
Real World Data 
RWE 
Real World Evidence 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
UK 
United Kingdom 
URTI 
Upper Respiratory tract Infection 
US 
United States 
USA 
United States of America 
USD 
United States Dollar 
USP 
United States Pharmacopeia 
USRE 
Unexpected Serious Related Event 
Wi-Fi 
Wireless Fidelity 
WURSS 
Wisconsin Upper Respiratory Symptom Survey 
 
 
 
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