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NCT03769090 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Bond Avillion 2 Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,132
- Enrollment target
NCT03769090: Completed Phase 3 study, sponsored by Bond Avillion 2 Development.
NCT03769090 is a Phase 3 study that has completed, run by Bond Avillion 2 Development. The registered enrollment target is 3,132 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (306% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769090, a Phase 3 study, has completed, sponsored by Bond Avillion 2 Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,132 participants
- Enrollment target
Study 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.
Primary Outcome
Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (\<24 h
Interventions
- COMBINATION_PRODUCT Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
- COMBINATION_PRODUCT Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
- DRUG Albuterol sulfate metered-dose inhaler 180 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,132 participants |
| Start Date | 2018-12-13 |
| Est. Completion | 2022-02-07 |
| Phase | Phase 3 |
What the finished NCT03769090 record still lists
NCT03769090 is an interventional study that assigns participants to a tested intervention. Its 3,132 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (306% higher).
The record links to 0 conditions, and to 3 interventions - of which Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg is the first listed.
NCT03769090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03769090 about?
NCT03769090 is a clinical study titled "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". 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.
What is the current status of trial NCT03769090?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,132 participants. The study started on 2018-12-13. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT03769090?
The interventions under investigation include: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg (COMBINATION_PRODUCT), Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg (COMBINATION_PRODUCT), Albuterol sulfate metered-dose inhaler 180 μg (DRUG).
Who is sponsoring clinical trial NCT03769090?
This trial is sponsored by Bond Avillion 2 Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03769090's enrollment target sits among peer trials
3,132 75th of 2000 higher than 1,926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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