Dry Powder Inhaler: Administration via dry powder inhaler
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 ≥100 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.
Primary outcome measure(s)
Change from Baseline in 6-Minute Walk Distance (6MWD) — Baseline to Week 24 The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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