Clinical trial NCT06422689: Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
Official title: ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Asthma
Keywords: Effectiveness
Asthma
Exacerbation
Healthcare resource utilization
Cost
Albuterol/budesonide
Short-acting beta-agonist (SABA)
Inhaled corticosteroids (ICS)
Rescue
Switch
Oral corticosteroid
Patients reported asthma symptoms
PT027
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Premier HealthCare Solutions Inc.
First posted: 2024-05-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy.

Detailed description: This study will primarily compare rates of asthma exacerbation during 12-month pre-switch period and 12-month post switch period among participants with asthma needing a rescue therapy. Other outcomes of interest for comparison between the pre- and post-switch periods include asthma-related oral corticosteroids (OCS) use, asthma exacerbation-related hospitalizations, emergency department (ED) visits, urgent care visits, outpatient visits, telehealth visits, and asthma-related and asthma exacerbation-related healthcare costs. The use of asthma control and rescue medications will be collected to understand treatment patterns in the real-world US context.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 years and above as of enrollment date.
2. At least 1 visit with primary or secondary diagnosis of asthma on or within 12 months prior to the enrollment date.
3. At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date.
4. At least 1 asthma exacerbation within 12 months before enrollment date.
5. Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date.
6. Participants also need to meet each of the following inclusion criteria:

   1. Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU).
   2. Willingness to respond to quarterly safety inquiries.
   3. Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text.
   4. Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI).

Exclusion Criteria:

1. Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date.
2. Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use.
3. Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 14 days or longer.
4. History of albuterol and budesonide as rescue use within 12 months before enrollment date.
5. History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date.
6. For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.

Primary outcomes:
measure: Asthma exacerbation
timeFrame: During 12-month pre-switch and 12-month post-switch periods
Secondary outcomes:
measure: Asthma exacerbation-related HCRU
timeFrame: During 12-month pre-switch and 12-mont post switch periods
measure: Asthma exacerbation-related cost
timeFrame: During 12-month pre-switch and 12-month post-switch periods
measure: Asthma-related cost
timeFrame: During 12-month pre-switch and 12-month post-switch periods
measure: Asthma- related Oral Corticosteroid (OCS) use
timeFrame: During 12-month pre-switch and 12-month post-switch periods
measure: Change in asthma exacerbation-related HCRU at health system level
timeFrame: During 12-month pre-switch and 12-month post-switch periods
Other outcomes:
measure: Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire
timeFrame: at 3-, 6-, 9-, and 12-month post-switch
measure: Asthma-related controller and rescue medication use
timeFrame: During 12-month pre-switch and 12-month post switch periods separately
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Greenville
country: United States
facility: Research Site
state: North Carolina
Study officials:
affiliation: University of Michigan, Michigan, USA
name: Njira Lugogo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefferson Health, Pennsylvania, USA
name: Neil Skolnik, MD
role: PRINCIPAL_INVESTIGATOR
References: