New inhaled therapy aims to ease lung blood pressure

NCT ID NCT04691154

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Healthy volunteers

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

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

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Summit Health Eastside Clinic

    Bend, Oregon, 97701, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • VA Greater Los Angeles Healthcare

    Los Angeles, California, 90073, United States

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