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)
TerminatedPhase 3Results postedLast updated 24 November 2023
What this trial tests
Phase 3 trial testing Inhaled treprostinil solution in Pulmonary Hypertension in 188 participants. Terminated before completion.
18 and older, any sex, with Pulmonary Hypertension or Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD)Primary· Baseline, Week 12
6 MWD was calculated at peak exposure (10 to 60 minutes after dosing). 6MWT was performed by standardized procedures for all participants. Participants were asked to walk a set course for 6 minutes (timed) and the distance walked (in meters) was recorded. Statistical analyses were not performed due to lack of appropriate sample size.
Baseline
Group
Value
95% CI
Original Crossover Design - Treprostinil
225.07
± 77.41
Original Crossover Design - Placebo
220.47
± 77.64
Contingent Parallel Design - Treprostinil
231.50
± 60.77
Contingent Parallel Design - Placebo
283.00
± 67.78
Change at Week 12
Group
Value
95% CI
Original Crossover Design - Treprostinil
-4.47
± 39.01
Original Crossover Design - Placebo
-5.14
± 50.71
Contingent Parallel Design - Treprostinil
20.33
± 116.99
Contingent Parallel Design - Placebo
18.5
± 42.49
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 6 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03794583 — Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
· Phase 3
· terminated
Other recruiting trials for Pulmonary Hypertension
Currently open trials in the same condition.
NCT07179380 — Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension
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· recruiting
NCT07073820 — A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have P
· Phase 2
· recruiting
NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept
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NCT07187206 — Safety and Efficacy of FETO in CDH Phase III
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· recruiting
NCT07206173 — Londrina Activities of Daily Living Protocol in Pulmonary Hypertension
· recruiting
Other United Therapeutics trials
Trials by the same sponsor.
NCT06388421 — DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease
· recruiting
NCT05060315 — Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin
· terminated
NCT05203510 — A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right
· Phase 4
· active not recruiting
NCT05255991 — Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 3
· completed
NCT04708782 — Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by United Therapeutics
Last refreshed: 24 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03496623.