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

Running, not enrolling · Phase 4

Conditions studied: Asthma

In brief

ANCHOR is a prospective, phase IV, interventional, single-arm, open-label study of 1,500 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.

Key facts

Study ID

NCT06422689

Run by

AstraZeneca

People needed

1511

Starts

2024-05-10

Expected to finish

2027-02-03

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years and above as of enrollment date.
• At least 1 diagnosis of asthma prior to the enrollment date documented in patient record.
• 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.
• At least 1 severe asthma exacerbation within 12 months before enrollment date.
• 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.
• Participants also need to meet each of the following inclusion criteria:
• Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU).
• Willingness to respond to quarterly safety inquiries.
• Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text.
• Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI).

You may not qualify if…

• 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.
• 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.
• 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 21 days or longer.
• History of albuterol and budesonide as rescue use within 12 months before enrollment date.
• History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date.
• For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.

Where it is running

• Research Site — North Hollywood, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Flint, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Greenville, North Carolina, United States
• Research Site — DuBois, Pennsylvania, United States
• Research Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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