Actively Recruiting
A Phase 4, Multicenter, Cluster Randomized, Open-label Study on the Effect of Emergency Department Initiation of Airsupra on Asthma Outcomes
Led by Massachusetts General Hospital · Updated on 2026-04-17
1860
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of starting Airsupra inhaler treatment in emergency departments (ED) on reducing acute asthma recurrence and other related outcomes over three months. The study focuses on adults aged 18 to 54 who visit the ED for asthma exacerbations and are discharged with a short course of systemic corticosteroids. This trial is a cluster randomized, open-label study comparing Airsupra use to usual care across multiple centers. Participants will be assigned by site to either receive usual care or Airsupra as their rescue inhaler along with corticosteroids. Airsupra dosing is as needed, with up to six doses per day. The study will run for about four to five months of enrollment per site, with follow-up assessments conducted at approximately 3, 6, and 12 weeks after the ED discharge to monitor asthma control, relapse, and recurrence. During the study, patients will complete interviews and chart reviews in the ED, and follow-up will include telephone or text contact to assess their clinical status and medication use. Medical records from before and after enrollment will be reviewed to identify asthma exacerbations. The main outcome is asthma recurrence within three months, with asthma control and early relapse also measured. Participants’ data will be securely managed throughout the study period, which extends up to 12 weeks post-ED visit.
CONDITIONS
Brief Title
45th Multicenter Airway Research Collaboration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute asthma diagnosis
- Age between 18.0 and 54.9 years
- English and/or Spanish speaking
- Decision by emergency department attending to discharge patient to home on a short course of systemic corticosteroids
- (Intervention group only) Willingness to use Airsupra as rescue inhaler for the next 3 months
- Demonstration of acceptable metered dose inhaler administration technique
- Provision of informed consent before any study procedures
You will not qualify if you...
- Involvement in planning or conduct of the study
- Previous enrollment in this study
- Prior diagnosis of COPD, chronic bronchitis, or emphysema
- Use of systemic corticosteroids in the past 2 weeks
- Participation in another clinical study with an investigational product during the past 4 weeks or 3 months after enrollment
- Concurrent pneumonia
- Clinically significant cardiovascular disease or cancer
- Known hypersensitivity to Airsupra, albuterol sulfate, budesonide, or any product excipients
- For women: currently pregnant or breastfeeding
- For sexually active women of child-bearing age: not using or planning to use adequate contraception over the study period
- Lack of a working cell phone and working email address
- Expected unavailability for follow-up at approximately 3, 6, and 12 weeks
- Inability to provide an alternate contact with a working cell phone and email address
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) in the Emergency Department
Duration - Up to 3 months after the Emergency Department visit
Participants receive either usual care or Airsupra as a rescue inhaler along with a short course of systemic corticosteroids after discharge from the Emergency Department.
Initial treatment starts at the Emergency Department discharge with follow-up assessments at approximately 3, 6, and 12 weeks
Duration - Up to 3 months after treatment
Participants are followed up by phone or text to assess asthma control, acute asthma relapse, medication use, and adverse effects after treatment.
Follow-up contacts approximately at 3, 6, and 12 weeks after Emergency Department discharge
Trial Site Locations
Total: 1 location
1
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
Research Team
C
Carlos A Camargo, MD, DrPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here