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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L606 (in combination with nebulizer) | Experimental |
| |
| Placebo (in combination with nebulizer) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L606 | Drug | L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks | |
| Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liquidia Point of Contact | Contact | 1-888-241-6906 | LiquidiaStudies@liquidia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists, Ltd. | Recruiting | Scottsdale | Arizona | 85258 | United States | |
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|
| Placebo | Drug | Placebo will match L606 but contain no treprostinil. |
|
| 16 weeks |
| Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) | 24 weeks |
| Tampa General Hospital |
| Recruiting |
| Tampa |
| Florida |
| 33606 |
| United States |
|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| St. Vincent Cardiovascular Research Institute | Recruiting | Indianapolis | Indiana | 46260 | United States |
|
| Summit Health | Recruiting | Bend | Oregon | 97701 | United States |
|
| Ordensklinikum Linz GmbH | Recruiting | Linz | 4020 | Austria |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| Assistance Publique Hopitaux De Paris | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
| Universitätsklinikum Giessen und Marburg - Standort Giessen | Recruiting | Giessen | 35392 | Germany |
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Pauls Stradinš Clinical University Hospital | Recruiting | Riga | LV-1002 | Latvia |
| Unidade Local De Saude De Almada-Seixal E.P.E. | Recruiting | Almada | 2805-267 | Portugal |
| Hospital Del Mar | Recruiting | Barcelona | 08003 | Spain |
| Royal United Hospitals Bath NHS Foundation Trust | Recruiting | Bath | United Kingdom |
| University Hospitals Plymouth NHS Trust - Derriford Hospital | Recruiting | Plymouth | PL6 8DH | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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