Trials / Completed
CompletedNCT04234464
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
A Randomized, Double-blind, Single-dose, 2-Period, Crossover Study to Assess the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects With Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Bond Avillion 2 Development LP · Industry
- Sex
- All
- Age
- 12 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg | Budesonide/albuterol sulfate combination inhalation aerosol single dose |
| COMBINATION_PRODUCT | Placebo metered-dose inhaler | Placebo inhalation aerosol single dose |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2020-08-28
- Completion
- 2020-08-28
- First posted
- 2020-01-21
- Last updated
- 2022-01-13
- Results posted
- 2021-12-30
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04234464. Inclusion in this directory is not an endorsement.