BridgeMD
A clinical study to test how safe and effective a new inhaled treatment (called L606) is for people with high blood pressure in the lungs due to interstitial lung disease
EU CTIS ID: 2024-517943-29-00
What this study is testing
To evaluate the effect of inhaled L606 on the change in walk distance as measured by the six-minute walk test (6MWT) in WHO Group 3 participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is between 18 years to 80 years old
- Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging
- Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: a. Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5, and b. Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and c. Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg
- FEV1/FVC (ratio) > 0.70
- 6-minute walk distance ≥ 150 meters
You likely can't join if
- PH in the updated WHO Classification Groups 1, 2, 4, or 5
- Has evidence of clinically significant left-sided heart disease as defined by echocardiography
- Participants with history of persistent/permanent or uncontrolled atrial fibrillation
- Participants with severe obstructive sleep apnea
- Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics
- Initiation of pulmonary rehabilitation
See the full eligibility criteria
- Participant is between 18 years to 80 years old
- Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging
- Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: a. Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5, and b. Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and c. Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg
- FEV1/FVC (ratio) > 0.70
- 6-minute walk distance ≥ 150 meters
- PH in the updated WHO Classification Groups 1, 2, 4, or 5
- Has evidence of clinically significant left-sided heart disease as defined by echocardiography
- Participants with history of persistent/permanent or uncontrolled atrial fibrillation
- Participants with severe obstructive sleep apnea
- Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics
- Initiation of pulmonary rehabilitation
- Severe coronary heart disease or unstable angina or myocardial infarction within 180 days prior to Screening
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Mexico
- Australia
- Argentina
- Singapore
- Brazil
- Taiwan
- China
- Colombia
- United States
- United Kingdom
- Turkey
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Mexico; Australia; Argentina; Singapore; Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.