Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT07179380 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344
Last updated 2026-05-04
Summary
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
Conditions
- Pulmonary Hypertension
- Interstitial Lung Disease
Interventions
- DRUG
-
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
- DRUG
-
Oral inhalation using a capsule-based dry powder inhaler device.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-07
- Primary Completion
- 2028-12-30
- Completion
- 2028-12-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Czechia
- Denmark
- France
- Georgia
- Germany
- Greece
- Israel
- Italy
- Japan
- Malaysia
- New Zealand
- Portugal
- Romania
- South Korea
- Spain
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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