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
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).
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 are admitted and, among those discharged, approximately 15-20% relapse (i.e., return to the ED for further treatment of their index exacerbation). A 2000 Cochrane review evaluated if starting inhaled corticosteroids (ICS) at ED discharge would lower risk of relapse during the 2-3 weeks after the ED visit. The meta-analysis included three randomized controlled trials (RCTs) and found borderline signi…
Eligibility
- Age range
- 18–54 years
- Sex
- All
- Healthy volunteers
- No
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 emphy…
Interventions
- DrugAirsupra
1 dose (2 inhalations) PRN, with maximum of 6 doses (12 inhalations) in a 24-hour period
Location
- MetroHealthCleveland, Ohio