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Insmed TPIP Study

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

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Interstitial lung diseases, Pulmonary hypertension
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All genders
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Overview

Principal Investigator: Nicholas Hill, MD

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
  • Diagnosis of Pulmonary Hypertension associated with Interstitial Lung Disease (including IIP, IPF, CTD, sarcoidosis)
  • Qualifying results in Pulmonary Function test at screening
  • Can walk at least 100 meters in 6 minute walk test
Exclusion Criteria
  • Primary diagnosis of chronic obstructive pulmonary disease (COPD)
  • Received or currently treatment with any pulmonary hypertension medication in past 30 days
  • 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.

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