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A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)

RecruitingPhase 3Ages 18 Years - 85 YearsAllPulmovant, Inc.
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In plain words

What the trial is, and whether it could suit you

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants willing and able to provide informed consent. * Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic Hypersensitivity pneumonitis 3. ILD associated connective tissue disease (CTD) * Confirmed pulmonary hypertension by right heart catheterization (RHC). * Ability to perform 6-minute walk distance โ‰ฅ100 meters. Exclusion Criteria: * Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified). * Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization * Receiving \>10 L/min oxygen supplementation by any mode of delivery at rest * History of intolerance to mosliciguat, or sGC stimulators or activators. * Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization. * Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.
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What it tests

  • Mosliciguat
  • Placebo
  • Dry Powder Inhaler
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Where

3 sites
Clinical Research Site
Kissimmee, United States
Clinical Research Site
Louisville, United States
Clinical Research Site
Bend, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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