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NCT05165485 · ClinicalTrials.gov registry record · Phase 4

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

A Phase 4 study, sponsored by Theravance Biopharma.

Completed
Registry status
Phase 4
Development phase
404
Enrollment target

NCT05165485: Completed Phase 4 study, sponsored by Theravance Biopharma.

NCT05165485 is a Phase 4 study that has completed, run by Theravance Biopharma. The registered enrollment target is 404 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05165485, a Phase 4 study, has completed, sponsored by Theravance Biopharma.

COMPLETED
Registry status
Phase 4
Development phase
404 participants
Enrollment target

Study Summary

Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.

Primary Outcome

Change from baseline in forced expiratory volume in one second (FEV1) at trough on Day 85

Interventions

  • DRUG Tiotropium
  • DRUG Revefenacin
  • DRUG Revefenacin Placebo
  • DRUG Tiotropium Placebo

Trial Details

FieldValue
Enrollment Target 404 participants
Start Date 2022-01-07
Est. Completion 2023-11-20
Phase Phase 4
Theravance Biopharma

38 total trials

What the finished NCT05165485 record still lists

NCT05165485 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower).

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

NCT05165485 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05165485 about?

NCT05165485 is a clinical study titled "Phase 4 COPD and Suboptimal Inspiratory Flow Rate". Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.

What is the current status of trial NCT05165485?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 404 participants. The study started on 2022-01-07. Estimated completion is 2023-11-20.

What interventions are being tested in trial NCT05165485?

The interventions under investigation include: Tiotropium (DRUG), Revefenacin (DRUG), Revefenacin Placebo (DRUG), Tiotropium Placebo (DRUG).

Who is sponsoring clinical trial NCT05165485?

This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05165485's enrollment target sits among peer trials

404 209th of 2000 higher than 1,791 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT05165485, the US trial registry maintained by the National Library of Medicine. NCT05165485 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.