ACTIVE_NOT_RECRUITING

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

Conditions

Asthma Effectiveness Exacerbation Healthcare resource utilization Cost Albuterol/budesonide Short-acting beta-agonist (SABA)Inhaled corticosteroids (ICS)Rescue Switch Oral corticosteroid Patients reported asthma symptoms PT027

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-10

Study Completion:2026-04-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06422689

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.

Ages Eligible for Study:18 Years to 130 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults aged 18 years and above as of enrollment date. 2. At least 1 diagnosis of asthma prior to the enrollment date documented in patient record. 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 severe 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 21 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.

Inclusion Criteria

Exclusion Criteria

1. Adults aged 18 years and above as of enrollment date.
2. At least 1 diagnosis of asthma prior to the enrollment date documented in patient record.
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 severe 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 21 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.

Contacts and Locations

Study Locations (Sites)

Research Site

North Hollywood, California, 91602

United States

Research Site

Walnut Creek, California, 94598

United States

Research Site

Louisville, Kentucky, 40217

United States

Research Site

Boston, Massachusetts, 02111

United States

Research Site

Ann Arbor, Michigan, 48109

United States

Research Site

Flint, Michigan, 48532

United States

Research Site

Minneapolis, Minnesota, 55425

United States

Research Site

Asheville, North Carolina, 28803

United States

Research Site

Greenville, North Carolina, 27834

United States

Research Site

DuBois, Pennsylvania, 15801

United States

Research Site

Austin, Texas, 78738

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-10

Study Completion Date2026-04-29

Study Record Updates

Study Start Date2024-05-10

Study Completion Date2026-04-29

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Asthma