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NCT03756883 · ClinicalTrials.gov registry record · Phase 3
Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 999
- Enrollment target
NCT03756883: Completed Phase 3 study, sponsored by Actavis.
NCT03756883 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 999 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03756883, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 999 participants
- Enrollment target
Study Summary
A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints
Primary Outcome
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
Interventions
- DRUG Placebo Inhalation Powder
- DRUG Fluticasone Propionate and Salmeterol Inhalation Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 999 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2019-11-10 |
| Phase | Phase 3 |
What the finished NCT03756883 record still lists
NCT03756883 is an interventional study that assigns participants to a tested intervention. The registered 999 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Inhalation Powder is the first listed.
NCT03756883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03756883 about?
NCT03756883 is a clinical study titled "Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma". A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints
What is the current status of trial NCT03756883?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 999 participants. The study started on 2018-12-03. Estimated completion is 2019-11-10.
What interventions are being tested in trial NCT03756883?
The interventions under investigation include: Placebo Inhalation Powder (DRUG), Fluticasone Propionate and Salmeterol Inhalation Powder (DRUG).
Who is sponsoring clinical trial NCT03756883?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03756883's enrollment target sits among peer trials
999 312th of 2000 higher than 1,689 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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