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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03769090
The ClinicalTrials.gov registry entry for NCT03769090 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bond Avillion 2 Development, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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