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Bronchodilator

Phase 4 COPD and Suboptimal Inspiratory Flow Rate (PIFR-2 Trial)

Phase 4
Waitlist Available
Research Sponsored by Theravance Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 30, day 60, day 85
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 30, day 60, day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 30, day 60, day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
80-mL Increase in FEV1 at Trough on Day 85
FEV1
FVC
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RevefenacinExperimental Treatment2 Interventions
Revefenacin administered with Tiotropium Placebo
Group II: TiotropiumActive Control2 Interventions
Tiotropium administered with Revefenacin Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Revefenacin
2022
Completed Phase 4
~740
Tiotropium Placebo
2022
Completed Phase 4
~410

Find a Location

Who is running the clinical trial?

Viatris Inc.Industry Sponsor
9 Previous Clinical Trials
5,022 Total Patients Enrolled
Theravance BiopharmaLead Sponsor
73 Previous Clinical Trials
8,215 Total Patients Enrolled
Mylan Inc.Industry Sponsor
62 Previous Clinical Trials
20,418 Total Patients Enrolled
Medical MonitorStudy DirectorTheravance Biopharma
1,678 Previous Clinical Trials
989,694 Total Patients Enrolled
~101 spots leftby Jan 2026
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