Pulmonary Hypertension Due to Lung Disease (Disorder)Phase 3Re-SpireNCT07285655
A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
A Phase 3 study testing L606 in people with Pulmonary Hypertension Due to Lung Disease (Disorder), run by Liquidia Technologies, Inc. at 44 sites in 12 countries.
Trial summary
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension Due to Lung Disease (Disorder)
- What is being tested?
- L606
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 44 sitesin 12 countries
- Study dates
- 23 Apr 2026to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
- Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and
- - 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
Who cannot join
- 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.
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
44 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 12 countries
United States13 sites, 13 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Johan Allingmon, johan.allingmon@cuanschutz.edu
- Recruiting
Summit Health
Bend, Oregon, 97701
Madison Cox, 541-706-5339, mklinskicox@summithealth.com
- Recruiting
Medical University of South Carolina- Nexus Research Clinic
Charleston, South Carolina, 29425
Ashley Ward, 843-792-4349, jonesash@musc.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
National Jewish Hospital
Denver, Colorado, 80206
Skyler Chenaille, chenailles@njhealth.org
- Recruiting
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260
Morgan Arnold, 317-338-9337, morgan.arnold@ascension.org
- Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1690
Jaclene Torres, jaclenetorres@mednet.ucla.edu
- Recruiting
NYU Langone Health
New York, New York, 10016
Anabela Barroso, anabela.barroso@nyulangone.org
- Recruiting
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Jennifer Guthrie, jennifer.guthrie@commonspirit.org
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Andrew Mintz, andrew_mintz@urmc.rochester.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Sarah Mettias, sarah.mettias@ucsf.edu
- Recruiting
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, 85258
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Elisabeth Ballans, eballans@tgh.org
Germany8 sites, 8 recruiting
- Recruiting
Universitaetsklinikum Koeln AöR
Cologne, 50937
- Recruiting
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen GmbH
Essen, 45239
- Recruiting
Universitätsklinikum Giessen und Marburg - Standort Giessen
Giessen, 35392
- Recruiting
Universitaetsmedizin Greifswald KöR
Greifswald, 17489
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
- Recruiting
Krankenhaus Neuwittelsbach
Munich, 80639
- Recruiting
LMU Klinikum Muenchen AöR
Munich, 81377
United Kingdom5 sites, 5 recruiting
- Recruiting
Royal United Hospitals Bath NHS Foundation Trust
Bath
- Recruiting
Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital
London, NW3 2QG
- Recruiting
Royal Bromptom Hospital
London, SW3 6NP
- Recruiting
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, PL6 8DH
- Recruiting
Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF
Belgium3 sites, 3 recruiting
- Recruiting
Hopital Erasme
Anderlecht, 1070
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
UZ Leuven
Leuven, 3000
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genoa, 16132
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, 00161
Portugal3 sites, 3 recruiting
- Recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada, 2805-267
- Recruiting
Unidade Local De Saude De Coimbra E.P.E.
Coimbra, 3004-561
- Recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, 4050-011
Spain3 sites, 3 recruiting
- Recruiting
Hospital Del Mar
Barcelona, 08003
- Recruiting
Hospital Clinic De Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Marques De Valdecilla
Santander, 39008
France2 sites, 2 recruiting
- Recruiting
Hospices Civils De Lyon
Bron, 69500
- Recruiting
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicêtre, 94270
Australia1 site, 1 recruiting
- Recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradinš Clinical University Hospital
Riga, LV-1002
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.
- Being tested
- L606, Placebo
- Keywords
- pulmonary hypertension, interstitial lung disease
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L606Drug
Also called Treprostinil Liposome Inhalation Suspension
L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.
PlaceboDrug
Placebo will match L606 but contain no treprostinil.
| Study group | Role | What they receive |
|---|---|---|
| L606 (in combination with nebulizer) | Experimental | Not described Receives: Drug: L606 |
| Placebo (in combination with nebulizer) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Measured: 16 weeks
Secondary outcomes (3)
Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart
Measured: 24 weeks
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Measured: 16 weeks
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start23 Apr 2026
- Primary completionJul 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Due to Lung Disease (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liquidia Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285655
- Sponsor's protocol ID
- L606-301
- Acronym
- Re-Spire
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)
- ClinicalTrials.gov ID
- NCT07285655
- Acronym / sponsor ID
- Re-Spire / L606-301
- Keywords
- pulmonary hypertension, interstitial lung disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Liquidia Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L606 (in combination with nebulizer) | Experimental | Drug: L606 |
| Placebo (in combination with nebulizer) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
- Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L606Also: Treprostinil Liposome Inhalation SuspensionL606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer. | Drug | L606 (in combination with nebulizer) |
| PlaceboPlacebo will match L606 but contain no treprostinil. | Drug | Placebo (in combination with nebulizer) |
Primary outcome
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Time frame: 16 weeks
3 secondary outcomes
Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart
Time frame: 24 weeks
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Time frame: 16 weeks
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
44 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L606 in people with Pulmonary Hypertension Due to Lung Disease (Disorder), run by Liquidia Technologies, Inc. at 44 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Germany, United Kingdom, Belgium, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liquidia Point of Contact (1-888-241-6906, LiquidiaStudies@liquidia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.