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

Description

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.

Conditions

Asthma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Boston

Research Site, Boston, Massachusetts, United States, 02111

Springfield

Research Site, Springfield, Massachusetts, United States, 01199

Ann Arbor

Research Site, Ann Arbor, Michigan, United States, 48109

Flint

Research Site, Flint, Michigan, United States, 48532

Minneapolis

Research Site, Minneapolis, Minnesota, United States, 55425

Greenville

Research Site, Greenville, North Carolina, United States, 27834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Njira Lugogo, MD, PRINCIPAL_INVESTIGATOR, University of Michigan, Michigan, USA

Neil Skolnik, MD, PRINCIPAL_INVESTIGATOR, Jefferson Health, Pennsylvania, USA

Study Record Dates

2026-04-29