Recruiting
45th Multicenter Airway Research Collaboration
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).
ClinicalTrials.gov IDNCT07166939
PhasePHASE4
Enrollment1860
SponsorMassachusetts General Hospital
Age18 Years
SexALL
Conditions studied
Asthma Acute, Asthma Exacerbation, Asthma, Asthma Control Level
About this study
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).
Interventions
- Drug: Airsupra — 1 dose (2 inhalations) PRN, with maximum of 6 doses (12 inhalations) in a 24-hour period
Primary outcomes
- acute asthma recurrence (3 months)
Eligibility information
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.
Study locations
- MetroHealth, Cleveland, Ohio 44109 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.