Trials / Completed
CompletedNCT03769090
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,132 (actual)
- Sponsor
- Bond Avillion 2 Development LP · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg | Budesonide/albuterol sulfate combination inhalation aerosol |
| COMBINATION_PRODUCT | Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg | Budesonide/albuterol sulfate combination inhalation aerosol |
| DRUG | Albuterol sulfate metered-dose inhaler 180 μg | Albuterol sulfate inhalation aerosol |
Timeline
- Start date
- 2018-12-13
- Primary completion
- 2021-08-19
- Completion
- 2022-02-07
- First posted
- 2018-12-07
- Last updated
- 2022-09-28
- Results posted
- 2022-09-28
Locations
345 sites across 11 countries: United States, Argentina, Canada, Czechia, Germany, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03769090. Inclusion in this directory is not an endorsement.