Trial studying safety and effects for Pulmonary Hypertension
Official title Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
ClinicalTrials.gov ID: NCT07179380
What this study is testing
What is Treprostinil Palmitil Inhalation Powder?
This is an investigational inhaled powder being studied to see if it helps with exercise capacity in adults with pulmonary hypertension associated with interstitial lung disease. It is designed to widen the blood vessels in the lungs to lower blood pressure there.
Also referred to as INS1009.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to see if taking a specific inhaled powder once a day improves how well participants can exercise compared to a fake treatment.
- Who it's for
- Adults who have high blood pressure in the lungs caused by scarring in the lung tissue.
- What's involved
- Participants will take an inhaled powder or a placebo once a day and undergo tests to measure their exercise ability.
- Time commitment
- The study lasts 24 weeks and requires regular visits to the clinic for testing.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD [including but not limited to idiopathic interstitial pneumonia (IIP)...
- Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12...
- 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).
You likely can't join if
- Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5 (including sarcoidosis), or subtypes of PH WHO Group 3 other than interstitial lung...
- Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)...
- 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...
- unstable ischemic heart disease
See the full eligibility 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...
- Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months.
- 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Gainesville, Florida, United States
- Naples, Florida, United States
- St. Petersburg, Florida, United States
- Kansas City, Kansas, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Bend, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Richmond, Virginia, United States
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina
- Río Cuarto, Córdoba Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Córdoba, Argentina
- Camperdown, New South Wales, Australia
- Kingswood, New South Wales, Australia
+ 128 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; San Francisco, California, United States; Santa Barbara, California, United States; Gainesville, Florida, United States; Naples, Florida, United States; St. Petersburg, Florida, United States and 142 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.