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NCT03095456 · ClinicalTrials.gov registry record · Phase 3

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

A Phase 3 study, sponsored by Mylan.

Completed
Registry status
Phase 3
Development phase
207
Enrollment target

NCT03095456: Completed Phase 3 study, sponsored by Mylan.

NCT03095456 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 207 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03095456, a Phase 3 study, has completed, sponsored by Mylan.

COMPLETED
Registry status
Phase 3
Development phase
207 participants
Enrollment target

Study Summary

This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.

Primary Outcome

FEV1 = forced expiratory volume at one second

Interventions

  • DRUG Revefenacin
  • COMBINATION_PRODUCT Spiriva Handihaler®
  • DRUG Placebo for Revefenacin
  • DRUG Placebo for Spiriva Handihaler®

Trial Details

FieldValue
Enrollment Target 207 participants
Start Date 2017-03-27
Est. Completion 2017-11-25
Phase Phase 3
Mylan

22 total trials

What the finished NCT03095456 record still lists

NCT03095456 is an interventional study that assigns participants to a tested intervention. The registered 207 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 (73% lower).

The record links to 0 conditions, and to 4 interventions - of which Revefenacin is the first listed.

NCT03095456 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03095456 about?

NCT03095456 is a clinical study titled "Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD". This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.

What is the current status of trial NCT03095456?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 207 participants. The study started on 2017-03-27. Estimated completion is 2017-11-25.

What interventions are being tested in trial NCT03095456?

The interventions under investigation include: Revefenacin (DRUG), Spiriva Handihaler® (COMBINATION_PRODUCT), Placebo for Revefenacin (DRUG), Placebo for Spiriva Handihaler® (DRUG).

Who is sponsoring clinical trial NCT03095456?

This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03095456's enrollment target sits among peer trials

207 1346th of 2000 higher than 654 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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Source: ClinicalTrials.gov NCT03095456, the US trial registry maintained by the National Library of Medicine. NCT03095456 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.