Status:

RECRUITING

45th Multicenter Airway Research Collaboration

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Asthma Acute

Asthma Exacerbation

Eligibility:

All Genders

18-54 years

Phase:

PHASE4

Brief Summary

The study is a randomized controlled trial on the effect of emergency department initiation of Airsupra on acute asthma "recurrence" at 3 months and other related outcomes (acute asthma relapse, asthm...

Detailed Description

Acute asthma (or asthma exacerbation) is common and costly. In the USA, acute asthma accounts for approximately 2 million emergency department (ED) visits per year; approximately 10-20% of patients ar...

Eligibility Criteria

INCLUSION CRITERIA:

  • acute asthma
  • age 18.0 to 54.9 years
  • English and/or Spanish speaking
  • decision by ED attending to discharge patient to home on short course of systemic corticosteroids
  • (intervention group only) Willingness to use Airsupra as their rescue inhaler for next 3 months
  • demonstration of acceptable MDI administration technique
  • provision of informed consent prior to any study-specific procedures

EXCLUSION CRITERIA:

  • involvement in the planning and/or conduct of the study
  • previous enrolment in the present 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 the 3 months after enrollment in the current study
  • concurrent pneumonia
  • clinically significant cardiovascular disease or clinically significant cancer
  • patients with known hypersensitivity to Airsupra, albuterol sulfate, budesonide, or any of the excipients of the product
  • (for women only, by self-report):
  • currently pregnant
  • currently breastfeeding,
  • (among sexually active women of child-bearing age only) not using adequate contraception over the last 3 months, or no plan to use adequate contraception over the next 3 months
  • lack of a working cell phone and working email address
  • expected lack of availability for text and/or telephone follow-up at approximately 3, 6, and 12 weeks after the ED visit
  • inability to provide an alternate contact with a working cell phone and working email address.

Key Trial Info

Start Date :

November 7 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

1860 Patients enrolled

Trial Details

Trial ID

NCT07166939

Start Date

November 7 2025

End Date

June 1 2027

Last Update

April 17 2026

Active Locations (1)

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MetroHealth

Cleveland, Ohio, United States, 44109