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NCT03573817 · ClinicalTrials.gov registry record · Phase 3
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
A Phase 3 study, sponsored by Mylan.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT03573817: Completed Phase 3 study, sponsored by Mylan.
NCT03573817 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03573817, a Phase 3 study, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Interventions
- DRUG Placebo
- DRUG Formoterol
- DRUG Revefenacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2018-09-25 |
| Phase | Phase 3 |
What the finished NCT03573817 record still lists
NCT03573817 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03573817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03573817 about?
NCT03573817 is a clinical study titled "A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD". The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very seve...
What is the current status of trial NCT03573817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2018-05-31. Estimated completion is 2018-09-25.
What interventions are being tested in trial NCT03573817?
The interventions under investigation include: Placebo (DRUG), Formoterol (DRUG), Revefenacin (DRUG).
Who is sponsoring clinical trial NCT03573817?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03573817's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 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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