New inhaled therapy aims to ease lung blood pressure
NCT ID NCT04691154
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new inhaled drug called L606 (liposomal treprostinil) in 28 adults with pulmonary arterial hypertension or PH-ILD. The goal is to see if it is safe and tolerable when taken twice daily, both short-term and over a year. Participants either switch from another inhaled drug or start L606 for the first time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liposomal treprostinil inhalation suspension (L606)
- What this could lead to
- If successful, this could offer a safer, more tolerable inhaled treatment option for people with pulmonary arterial hypertension or PH-ILD, potentially improving daily management.
- What could go wrong
- This is a small, open-label safety study with only 28 participants, so results may not apply broadly. Side effects from treprostinil can include headache, nausea, and jaw pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
28 people
The number who actually took part.
- Started
-
Aug 2021
- Expected to finish
-
Mar 2031
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Males and females ≥18 and ≤80 years of age. 2. Diagnosed with 1. PAH belonging to at least 1 of the following subgroups of Group 1 pulmonary hypertension (PH) per European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH at least 1 year prior to screening. or 2. PH-ILD Group 3 European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH. Subjects with Group 3 PH that is not related to underlying ILD are not eligible. 3. Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting the following criteria: i. Mean PAP \>20 mmHg. ii. Pulmonary arterial wedge pressure ≤15 mmHg. iii. Pulmonary vascular resistance \>3 Wood units. Subjects with PH-ILD: Confirmation of the underlying ILD must be based on HRCT imaging with demonstration of diffuse parenchymal lung disease and documented by the Investigator or radiology report. Subjects may have any form of ILD or CPFE. 4. NYHA functional class II, III, or IV at the screening visit. 5. Can complete a screening 6MWD of ≥150 meters 6. For subjects with PAH: \>65% of predicted and FEV1/FVC ratio \>65% at screening. For subjects with PH-ILD: \>40% of predicted and FEV1/FVC ratio \>70% at screening. Key Exclusion Criteria: 1. LVEF of ≤45% on a historical echocardiogram. 2. History of sleep apnea, or left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease) per investigator's discretion. 3. Experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of signing the ICF or prior to baseline. 4. Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation or subject is connected to a machine that is not portable enough to allow for a 6MWT.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Arizona Pulmonary Specialists
Scottsdale, Arizona, 85258, United States
-
Baylor Scott and White Research Institute
Temple, Texas, 76508, United States
-
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6504, United States
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Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
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Summit Health Eastside Clinic
Bend, Oregon, 97701, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
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University of South Florida
Tampa, Florida, 33606, United States
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VA Greater Los Angeles Healthcare
Los Angeles, California, 90073, United States
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