45th Multicenter Airway Research Collaboration
Recruiting · NCT07166939 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Airsupra
What this trial is about
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).
Who can take part
Age range
18 Years to 54 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- MetroHealth - Cleveland, Ohio, United States