45th Multicenter Airway Research Collaboration
A Phase 4, Multicenter, Cluster Randomized, Open-label, Intervention Versus Usual Care, Controlled Study on the Effect of Emergency Department Initiation of Airsupra on Asthma Outcomes
Massachusetts General Hospital
1,860 participants
Nov 7, 2025
INTERVENTIONAL
Conditions
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, asthma control).
Eligibility
Inclusion Criteria7
- 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 Criteria15
- 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.
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Interventions
1 dose (2 inhalations) PRN, with maximum of 6 doses (12 inhalations) in a 24-hour period
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07166939