Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outco… (NCT06422689) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
United States1,511 participantsStarted 2024-05-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 4, which means the treatments being studied are already approved — does that mean there's more known about their safety compared to earlier-phase trials, and how does that affect the risk-benefit conversation for me?
2The trial is studying whether combining a short-acting bronchodilator with an inhaled corticosteroid as rescue therapy reduces asthma exacerbations — is this a different approach from how I currently use my rescue inhaler, and is it something worth discussing as part of my treatment plan regardless of the trial?
3Since the trial is active but no longer recruiting, I can't join it — but are there similar studies still enrolling that are looking at rescue inhaler combinations for asthma that I might be eligible for?
4The main thing this trial is measuring is asthma exacerbations — based on how often I'm having flare-ups, do you think my current rescue therapy is working well enough, or is there a reason to explore a combined bronchodilator and corticosteroid approach?
5Would participating in or following the results of this kind of trial change any recommendations you'd make about my current asthma management, or is standard care still the better path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Asthma exacerbation
Timeframe: During 12-month pre-switch and 12-month post-switch periods
. 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.
Exclusion criteria
. 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.