NCT03496623

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)

A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, 34-week, cross-over study, with a Treatment Period of approximately 26 weeks under the Original Crossover Design or, if applicable, a 21-week parallel study, with a Treatment Period of approximately 14 weeks under the Contingent Parallel Design.

Conditions

• Pulmonary Hypertension
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Inhaled treprostinil solution	Treprostinil inhalation solution
DRUG	Placebo solution	Placebo solution

Timeline

• Start date: 2018-05-08
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2018-04-12
• Last updated: 2023-11-24
• Results posted: 2023-11-24

Locations

76 sites across 4 countries: United States, Argentina, Israel, Puerto Rico

Regulatory

• FDA-regulated drug study