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Phase 4 COPD and Suboptimal Inspiratory Flow Rate

NCT05165485 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2024-12-20

Study results available
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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.

Conditions

Interventions

DRUG

Revefenacin

Revefenacin 175 mcg administered once daily for 84 days via nebulization

DRUG

Tiotropium

Tiotropium 18 mcg administered once daily for 84 days via Spiriva HandiHaler®

DRUG

Revefenacin Placebo

Placebo for Revefenacin administered once daily for 84 days via nebulization

DRUG

Tiotropium Placebo

Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®

Sponsors & Collaborators

  • Viatris Inc.

    collaborator INDUSTRY

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2023-11-13
Completion
2023-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165485 on ClinicalTrials.gov