Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests TPIP, a powder breathed into the lungs once a day, against a placebo (a treatment with no active drug) for 24 weeks. It looks at how well adults can exercise when they have high blood pressure in the lungs linked to interstitial lung disease, which causes lung scarring.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have high blood pressure in the lungs linked to interstitial lung disease (called WHO Group 3 PH).
- Have lung scarring confirmed by a CT scan at screening or within the past 12 months. The study’s review team must check the scan.
- Have lung high blood pressure confirmed by a right heart catheter test at screening or within the past 12 months. This test uses a thin tube to measure pressures: average lung artery pressure must be above 20 mmHg, wedge pressure 15 mmHg or less, and resistance to blood flow at least 4 Wood units.
- Walk 100 to 500 meters in each of two 6-minute walking tests at screening. Tests must be at least 4 hours apart, and the distances must differ by no more than 15%.
- If taking long-term drugs for the underlying disease or drugs called PDE5 inhibitors, have taken them for at least 90 days and kept the same dose for at least 30 days before screening.
- Be able to sign a consent form and follow the study’s rules.
Who can't join
- Have another type of high blood pressure in the lungs, including disease linked to sarcoidosis.
- Have COPD, a disease that blocks airflow, as the main diagnosis, or have a breathing test ratio called FEV1/FVC below 0.7.
- Have serious disease on the left side of the heart, such as major valve disease, weak pumping, certain signs of heart failure, unstable heart disease from poor blood flow, or an uncontrolled heartbeat.
- Have long-term blood clots in the lung blood vessels, or a new lung blood clot within 6 months before screening.
- Have a known allergy or another medical reason not to use treprostinil, TPIP, or its ingredients, such as mannitol or leucine.
- Currently use cigarettes or e-cigarettes. The listing defines a current smoker as someone who has smoked at least 100 cigarettes in their life and still smokes every day or some days.
- Have inhaled marijuana for medical or other reasons in the 30 days before screening, or expect to use it during the study.
- Have another medical or mental health condition, or abnormal lab results, that the study doctor thinks could make the study unsafe, make it hard to finish, or affect the results.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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 6 minute walking test (6MWT)s 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 criteria * Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5 (including sarcoidosis), 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)/ forced vital capacity (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% * echocardiography findings at Screening suggestive for postcapillary (or combined pre and postcapillary) PH, heart failure with preserved ejection fraction (HFpEF), or heart failure with mildly reduced ejection fraction (HFmrEF), including left atrial volume index (LAVI) \>34 millilitres per metre square (mL/m\^2) * 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. Note: Other protocol defined inclusion/exclusion criteria may apply.
Study sites (19)
AZ
- USA027 · Phoenix, AZ 85013More trials in Phoenix
CA
- USA007 · Fresno, CA 93720More trials in Fresno
- USA010 · Los Angeles, CA 900275969More trials in Los Angeles
- USA023 · Los Angeles, CA 90095More trials in Los Angeles
- USA020 · San Francisco, CA 94143More trials in San Francisco
- USA001 · Santa Barbara, CA 93105-4349More trials in Santa Barbara
FL
- USA017 · Gainesville, FL 32610More trials in Gainesville
- USA006 · Naples, FL 34102-5412More trials in Naples
- USA026 · St. Petersburg, FL 33707-6129More trials in St. Petersburg
- USA028 · Tampa, FL 33606More trials in Tampa
KS
- USA002 · Kansas City, KS 66160More trials in Kansas City
NC
- USA022 · Chapel Hill, NC 27599More trials in Chapel Hill
- USA011 · Durham, NC 27710More trials in Durham
NY
- USA005 · New York, NY 10016More trials in New York
OH
- USA015 · Cincinnati, OH 45267More trials in Cincinnati
OR
- USA003 · Bend, OR 97701More trials in Bend
PA
- USA013 · Philadelphia, PA 19140More trials in Philadelphia
UT
- USA025 · Salt Lake City, UT 84018More trials in Salt Lake City
VA
- USA008 · Richmond, VA 23230More trials in Richmond