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Insmed TPIP Study

Title A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Therapeutic Area Interstitial Lung Diseases, Pulmonary Hypertension
Principal Investigator Nicholas Hill, MD
Min Age 18 Years
Max Age 75 Years
Gender Any
Contact Bipin Malla
617-636-6304
bmalla@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05176951

Overview

This is a Phase 2 study investigating safety and tolerability of Inhaled Treprostinil in participants with Pulmonary Hypertension associated with Interstitial Lung Disease.

Study Details

Inclusion Criteria

1. Diagnosis of Pulmonary Hypertension associated with Interstitial Lung Disease (including IIP, IPF, CTD, sarcoidosis)

2. Qualifying results in Pulmonary Function test at screening

3. Can walk at least 100 meters in 6 minute walk test

Exclusion Criteria

1. Primary diagnosis of chronic obstructive pulmonary disease (COPD)

2. Received or currently treatment with any pulmonary hypertension medication in past 30 days

3. History of Heart Disease

Study Requirements

Total of Eight clinic visits in a span of 20 weeks with Spirometry tests on all visits. All participants will undergo High resolution CT scan at the beginning and end of the study. Blood draws during six out of eight study visits.