A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Insmed Incorporated
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\]. * Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months. * PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening,…
Interventions
- DrugTreprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
- DrugPlacebo
Oral inhalation using a capsule-based dry powder inhaler device.
Locations (96)
- USA010Los Angeles, California
- USA001Santa Barbara, California
- USA006Naples, Florida
- USA003Bend, Oregon
- USA013Philadelphia, Pennsylvania
- USA008Richmond, Virginia