An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT05649722 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2026-04-23
Summary
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants 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 placebo inhalation using a capsule-based dry powder inhaler device.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-11
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-01
- FDA Drug
- Yes
Countries
- Argentina
- Australia
- Belgium
- Germany
- Italy
- Spain
- United Kingdom
Study Locations
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