Status:
NOT_YET_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
- 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, influenza, or COVID-19
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1860 Patients enrolled
Trial Details
Trial ID
NCT07166939
Start Date
September 1 2025
End Date
June 1 2026
Last Update
September 17 2025
Active Locations (1)
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1
MetroHealth
Cleveland, Ohio, United States, 44109