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Prostacyclin Analogue

A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD) (PERFECT Trial)

Loma Linda, CA
Phase 3
Waitlist Available
Research Sponsored by United Therapeutics
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, week 12
Awards & highlights
Pivotal Trial

Summary

This trial is testing if inhaled treprostinil can help improve exercise ability in people with PH-COPD, as measured by how far they can walk in 6 minutes.

See full description
Eligible Conditions
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD)
Secondary study objectives
Change From Baseline to Week 12 in 6MWD/Borg Dyspnea Composite Score
Change From Baseline to Week 12 in Borg Dyspnea Score
Change From Baseline to Week 12 in Moderate to Vigorous Physical Activity (MVPA)
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inhaled TreprostinilExperimental Treatment1 Intervention
Inhaled treprostinil delivered via an ultrasonic nebulizer with a target dosing regimen of 12 breaths (72 micrograms \[mcg\]) 4 times daily (QID)
Group II: PlaceboPlacebo Group1 Intervention
Placebo delivered via an ultrasonic nebulizer for QID administration

Find a Location

Closest Location:The Ohio State University Wexner Medical Center· Columbus, OH· 4 miles

Who is running the clinical trial?

United TherapeuticsLead Sponsor
110 Previous Clinical Trials
14,292 Total Patients Enrolled
Medical DirectorStudy DirectorUnited Therapeutics
2,965 Previous Clinical Trials
8,098,613 Total Patients Enrolled
~24 spots leftby Mar 2026
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