[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Liquidia Technologies, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100614904","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-l606-in-participants-with-ph-ild-100614904",false,"NCT07285655","A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD","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)","Re-Spire","Inclusion Criteria:\n\n* Participant is between 18 years to 80 years old.\n* Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.\n* Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:\n* Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec\u002Fcm5 (i.e. 4 Woods Units (WU)), and\n* Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and\n* \\- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.\n* FEV1\u002FFVC (ratio) \\> 0.70.\n* 6-minute walk distance ≥ 150 meters\n\nExclusion Criteria:\n\n* PH in the updated WHO Classification Groups 1, 2, 4, or 5.\n* Has evidence of clinically significant left-sided heart disease as defined by echocardiography.\n* Participants with history of persistent\u002Fpermanent or uncontrolled atrial fibrillation.\n* Participants with severe obstructive sleep apnea.\n* Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.\n* Initiation of pulmonary rehabilitation.\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","80 Years",{"count":21,"type":22},344,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Pulmonary Hypertension Due to Lung Disease (Disorder)",[30,31],"pulmonary hypertension","interstitial lung disease","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2026-04-23",{"date":40,"type":22},"2031-12",{"name":42,"class":43},"Liquidia Technologies, Inc.","INDUSTRY",16,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100526015","an-open-label-prospective-multicenter-study-to-evaluate-safety-and-tolerability-of-dry-powder-inhaled-treprostinil-in-ph-100526015","NCT06129240","An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH","An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension","ASCENT","Cohort A Key Inclusion Criteria:\n\n1. Males or Females between 18 years to 80 years of age.\n2. Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed, which demonstrates evidence of diffuse parenchymal lung disease and FEV1\u002FFVC (absolute values) ≥ 70% and are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following hemodynamic parameters.\n\n   1. i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg.\n\n      OR\n   2. An exploratory subset of subjects with ILD: i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 21 mmHg.\n3. 6-minute walk distance of ≥ 125 meters\n\nCohort A Key Exclusion Criteria:\n\nA Subject is not eligible for inclusion in the study if any of the following criteria apply:\n\n1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5.\n2. History of hemodynamically significant left-sided heart disease.\n3. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.\n4. Initiation of pulmonary rehabilitation.\n\nCohort B Key Inclusion Criteria\n\n1. Male or Females between 18 years to 75 years of age at Screening.\n2. Has a diagnosis of WHO Group 3 PH-ILD confirmed with CT chest imaging performed at the screening visit, which demonstrates evidence of diffuse parenchymal lung disease and FEV1\u002FFVC (absolute values) ≥70%. Subjects are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following documented parameters:\n\n   1. Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and\n   2. Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and\n   3. A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg\n3. Subjects must be on protocol specified dose of inhaled treprostinil QID not at treatment goal, and able to transition from their prescribed dose of inhaled Treprostinil therapy to LIQ861.\n4. 6-minute walk distance of ≥ 200 meters\n\nCohort B Key Exclusion Criteria\n\n1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5.\n2. Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®.\n3. History of Bronchospasm with Tyvaso or Tyvaso DPI.\n4. History of persistent moderate asthma or severe asthma.\n5. History of hemodynamically significant left-sided heart disease.\n6. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.",{"count":54,"type":22},80,"52 Weeks","OBSERVATIONAL","Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \\& 3 PH.",[59,60],"Pulmonary Hypertension","Interstitial Lung Disease","2026-06-24",{"date":63,"type":36},"2026-06-26",{"date":65,"type":36},"2023-12-28",{"date":67,"type":22},"2028-02-08",{"name":42,"class":43},23,""]