Study of Treprostinil Palmitil Inhalation Powder for PH-ILD
This study is testing a new inhaled medication called Treprostinil Palmitil Inhalation Powder (TPIP) for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD). PH-ILD is a condition where high blood pressure in the lungs (pulmonary hypertension) occurs alongside scarring of the lungs (interstitial lung disease). Researchers want to see if TPIP, taken once daily using an inhaler, can improve how far you can walk in six minutes compared to a placebo (an inactive substance). The study aims to enroll 344 adults aged 18 and older who have been diagnosed with PH-ILD, including various types like idiopathic interstitial pneumonia. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 344 participants. It compares Treprostinil Palmitil Inhalation Powder to a placebo.
- What's involved
- Participants will receive treatment once daily for 24 weeks. Your walking distance will be measured at the beginning and at Week 24.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at Week 24, indicating follow-up for at least this duration.
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NCT07179380
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Recruiting
PHASE3Ages 18+InterventionalTreatmentInsmed Incorporated
~344 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Treprostinil Palmitil Inhalation PowderPlacebo
At a glance
Recruiting sites
79 of 145 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in 6MWD Measured at Peak Exposure From Baseline to Week 24
Measured over Baseline, Week 24
Conditions
Where it's being run
145 sites across 81 statesSpain8
Turkey (Türkiye)7
Italy6
South Korea6
Taiwan6
New South Wales4
France4
Georgia4
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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, with the following hemodynamic findings:
Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and
Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and
Pulmonary vascular resistance (PVR) ≥4 wood units (WU).
6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%.
Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening.
Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion
Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease.
Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months).
Clinically significant left heart disease:
evidence of clinically significant left-sided valvular heart disease,
left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF)
echocardiography findings at Screening suggestive for postcapillary PH
unstable ischemic heart disease
unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed)
Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).
Current use of cigarettes or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.
Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study.
Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
What this trial measures
- Change in 6MWD Measured at Peak Exposure From Baseline to Week 24Baseline, Week 24