A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
NCT07805785 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2026-09-04
Summary
The primary objective of this study is to evaluate the effect of 52 weeks of once daily treatment with TPIP compared with placebo on lung function in adults with PPF.
Conditions
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
Principal Investigators
-
Study Director · Insmed Incorporated
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-12-01
- Primary Completion
- 2030-08-31
- Completion
- 2030-08-31
- FDA Drug
- Yes
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