What is Treprostinil Palmitil Inhalation Powder studying for pulmonary hypertension associated with interstitial lung disease?

Treprostinil Palmitil Inhalation Powder is being studied to see how it affects exercise capacity and other health outcomes in adults with pulmonary hypertension linked to interstitial lung disease. The research aims to understand whether this treatment can improve walking ability and reduce heart strain over 24 weeks. The study is sponsored by Insmed Incorporated and involves careful evaluation of the medication's effects.

Who may be eligible for this pulmonary hypertension clinical trial?

Adults aged 18 years and older diagnosed with pulmonary hypertension associated with interstitial lung disease may be eligible. Participants must have a confirmed diagnosis through tests like right heart catheterization and meet specific walking distance criteria. Current smokers and those with certain heart or lung conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this pulmonary hypertension clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07179380

Phase 3 Study of Treprostinil Palmitil Inhalation Powder to Treat Pulmonary Hypertension with Interstitial Lung Disease in Adults

Led by Insmed Incorporated · Updated on 2026-05-27

344

Participants Needed

109

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Treprostinil Palmitil Inhalation Powder TPIP on adults with pulmonary hypertension associated with interstitial lung disease PH-ILD. The study aims to compare 24 weeks of once-daily TPIP treatment versus placebo to assess changes in exercise capacity and other health measures. This phase 3, randomized, double-blind, placebo-controlled trial seeks to better understand the treatments impact on this condition. Participants will be randomly assigned to receive either TPIP starting at 80 micrograms daily, with doses increased up to a maximum tolerated dose of 1280 micrograms, or a placebo inhaled once daily for 24 weeks. Both treatments are delivered via a capsule-based dry powder inhaler device. The study is conducted across multiple centers and includes careful monitoring of drug levels and health outcomes over the treatment period. During the study, participants will undergo assessments including the six-minute walk distance test to measure exercise capacity, blood tests to evaluate heart strain markers, and symptom questionnaires related to pulmonary fibrosis. Researchers will monitor safety, treatment adherence, and clinical events throughout the 24 weeks. The trial will also track time to clinical worsening and major health events, with detailed evaluations at baseline and regular intervals until the study ends.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of pulmonary hypertension WHO Group 3 associated with interstitial lung disease including idiopathic interstitial pneumonia, chronic hypersensitivity pneumonitis, connective tissue disease-associated interstitial lung disease, or combined pulmonary fibrosis and emphysema.
Fibrotic interstitial lung disease confirmed by centrally reviewed CT scan performed at screening or within prior 12 months.
Pulmonary hypertension confirmed by right heart catheterization within 12 months prior to screening with mean pulmonary arterial pressure >20 mmHg, pulmonary capillary wedge pressure 64 15 mmHg, and pulmonary vascular resistance 64 4 wood units.
Six-minute walking distance between 100 and 500 meters on two tests performed at least 4 hours apart with less than or equal to 15% difference.
Stable chronic medication for underlying disease or PDE5 inhibitors for at least 30 days prior to screening and at least 90 days of treatment.
Ability to provide signed informed consent and comply with study requirements.

You will not qualify if you...

Pulmonary hypertension WHO Groups 1, 2, 4, or 5 or other PH WHO Group 3 subtypes besides interstitial lung disease.
Primary diagnosis of chronic obstructive pulmonary disease or FEV1/FVC ratio <0.7 within prior 6 months.
Clinically significant left heart disease including significant valvular heart disease, left ventricular failure with ejection fraction <45%, heart failure with preserved ejection fraction, echocardiography suggesting postcapillary PH, unstable ischemic heart disease, or unstable arrhythmia except controlled atrial fibrillation.
Evidence of chronic thromboembolic disease or recent acute pulmonary embolism within 6 months.
Known allergy or contraindication to treprostinil or TPIP ingredients.
Current use of cigarettes, e-cigarettes, or inhaled marijuana in the past 30 days or expected during the study.
Medical or psychological conditions or laboratory abnormalities that may pose risk, impede study completion, or confound results as judged by the investigator.
Other protocol defined inclusion/exclusion criteria may apply.

Research Team

Insmed Medical Information

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Phase 3 Study of Treprostinil Palmitil Inhalation Powder to Treat Pulmonary Hypertension with Interstitial Lung Disease in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria