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NCT03847896 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily 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
- 1,001
- Enrollment target
NCT03847896: Completed Phase 3 study, sponsored by Bond Avillion 2 Development.
NCT03847896 is a Phase 3 study that has completed, run by Bond Avillion 2 Development. The registered enrollment target is 1,001 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847896, a Phase 3 study, has completed, sponsored by Bond Avillion 2 Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,001 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.
Interventions
- COMBINATION_PRODUCT Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)
- COMBINATION_PRODUCT Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)
- DRUG Budesonide metered dose inhaler / BD MDI 160 µg
- DRUG Albuterol sulfate metered dose inhaler / AS MDI 180 μg
- OTHER Placebo metered-dose inhaler / Placebo MDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,001 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2021-07-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03847896
The ClinicalTrials.gov registry entry for NCT03847896 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,001 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 5 interventions - of which Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose) is the first listed.
NCT03847896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03847896 about?
NCT03847896 is a clinical study titled "A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma". This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of tr...
What is the current status of trial NCT03847896?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,001 participants. The study started on 2019-03-20. Estimated completion is 2021-07-20.
What interventions are being tested in trial NCT03847896?
The interventions under investigation include: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose) (COMBINATION_PRODUCT), Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose) (COMBINATION_PRODUCT), Budesonide metered dose inhaler / BD MDI 160 µg (DRUG), Albuterol sulfate metered dose inhaler / AS MDI 180 μg (DRUG), Placebo metered-dose inhaler / Placebo MDI (OTHER).
Who is sponsoring clinical trial NCT03847896?
This trial is sponsored by Bond Avillion 2 Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
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