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A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma (TYREE)
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.
Details
| Lead sponsor | Bond Avillion 2 Development LP |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | Wed Jan 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Aug 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Exercise Induced Bronchospasm
Interventions
- Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
- Placebo metered-dose inhaler
Countries
United States