Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care

Asthma Clinical Trial

— ANCHOR  

Official title:

ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422689
• Other study ID #: D6930L00001
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2024
• Est. completion date: April 29, 2026

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 29, 2026
• Est. primary completion date: April 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Albuterol and budesonide inhalation aerosol
Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period.

Locations

Country	Name	City	State
United States	Research Site	Flint	Michigan
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Premier HealthCare Solutions Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire	Percentage of patients who reported improvement in asthma symptoms and satisfaction with albuterol and budesonide treatment as rescue therapy	at 3-, 6-, 9-, and 12-month post-switch
Other	Asthma-related controller and rescue medication use	Number of fills of asthma-related controllers and rescue medications	During 12-month pre-switch and 12-month post switch periods separately
Primary	Asthma exacerbation	Annualized Severe Asthma exacerbation rate	During 12-month pre-switch and 12-month post-switch periods
Secondary	Asthma exacerbation-related HCRU	Percentage of patients with Asthma exacerbation-related HCRU	During 12-month pre-switch and 12-mont post switch periods
Secondary	Asthma exacerbation-related cost	Asthma exacerbation-related cost in US Dollars	During 12-month pre-switch and 12-month post-switch periods
Secondary	Asthma-related cost	Asthma-related cost in US Dollars	During 12-month pre-switch and 12-month post-switch periods
Secondary	Asthma- related Oral Corticosteroid (OCS) use	Mean number of Asthma- related Oral Corticosteroid (OCS) prescriptions	During 12-month pre-switch and 12-month post-switch periods
Secondary	Change in asthma exacerbation-related HCRU at health system level	Percentage of patients with Asthma exacerbation-related HCRU at the health system level	During 12-month pre-switch and 12-month post-switch periods