Treprostinil Powder for Pulmonary Hypertension and Lung Disease

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Recruiting Phase 3 Interventional Study
Pulmonary Hypertension Interstitial Lung Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
344 (estimated)
Sponsor
Insmed Incorporated · Industry
Who this trial is looking for

This trial is looking for adults with pulmonary hypertension linked to interstitial lung disease. Participants will take either a study drug called TPIP or a placebo once a day for 24 weeks and will be monitored for their exercise ability.

Are You a Good Fit for This Trial?
Rules you out Chronic obstructive pulmonary diseaseSignificant heart diseaseChronic thromboembolic disease

You may be able to join if

  • I have been diagnosed with pulmonary hypertension associated with interstitial lung disease.
  • I have had a CT scan confirming fibrotic interstitial lung disease within the last year.
  • I have had a right heart catheterization confirming pulmonary hypertension within the last year.
  • I can walk between 100 and 500 meters in 6 minutes.
  • I am currently on stable medication for my underlying disease for at least 30 days.
  • I can provide signed consent to participate in the study.

You may not be able to join if

  • I have been diagnosed with a different type of pulmonary hypertension.
  • I have been diagnosed with chronic obstructive pulmonary disease.
  • I have significant heart disease or heart failure.
  • I have evidence of chronic blood clots in my lungs.
  • I am allergic to treprostinil or its components.
  • I currently smoke cigarettes or use e-cigarettes.
  • I currently use inhaled marijuana.
  • I have any other serious medical condition that may affect the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 pul…
Contacts

Insmed Medical Information

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medicalinformation@insmed.com

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