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45th Multicenter Airway Research Collaboration
RECRUITINGPhase 4Sponsored by Massachusetts General Hospital
Actively Recruiting
PhasePhase 4
SponsorMassachusetts General Hospital
Started2025-11-07
Est. completion2027-06
Eligibility
Age18 Years – 54 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07166939
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
Age: 18 Years – 54 YearsHealthy volunteers accepted
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.
Conditions4
AsthmaAsthma AcuteAsthma Control LevelAsthma Exacerbation
Interventions1
Locations1 site
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Actively Recruiting
PhasePhase 4
SponsorMassachusetts General Hospital
Started2025-11-07
Est. completion2027-06
Eligibility
Age18 Years – 54 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07166939