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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 4
Age: 18Years - 54Years
All Genders
ID07166939

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

Age: 18Years - 54Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

C

Carlos A Camargo, MD, DrPH

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