A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
- Conditions
- Pulmonary HypertensionPulmonary Fibrosis
- Interventions
- Combination Product: PlaceboCombination Product: INOpulse®Combination Product: Long Term Follow Up
- Registration Number
- NCT05747508
- Lead Sponsor
- Bellerophon
- Brief Summary
A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.
- Detailed Description
A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 85
-
Diagnosed with pulmonary fibrosis by high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using one of the following guidelines, as per American Thoracic Society (AGS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
-
Major idiopathic interstitial pneumonias (IIPs) diagnosis or suspected as one of the following:
- Idiopathic pulmonary fibrosis
- Idiopathic nonspecific interstitial pneumonia
- Respiratory bronchiolitis-interstitial lung disease
- Desquamative interstitial pneumonia
- Cryptogenic organizing pneumonia
- Acute interstitial pneumonia
-
Rare IIPs diagnosis by one of the following:
- Idiopathic lymphoid interstitial pneumonia
- Idiopathic pleuroparenchymal fibroelastosis
-
Unclassifiable idiopathic interstitial pneumonias
-
Chronic hypersensitivity pneumonitis
-
Occupational lung disease
-
-
Have been using oxygen therapy by nasal cannula for at least 4 weeks
-
6-Minute Walk Distance (6MWD) ≥ 100 meters and ≤ 450 meters at screening and Baseline/Randomization visits
-
World Health Organization (WHO) Functional Class II-IV
-
Forced Vital Capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period
-
Age between 18 and 85 years (inclusive)
- Pregnant or breastfeeding females at Screening
- In the last 6 months prior to screening, evidence of any connective tissue disease with FVC > 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the local radiologist/Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Pulsed inhaled N2, 99.999% gas Inhaled Nitric Oxide (iNO) INOpulse® Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr) Long Term Follow Up Long Term Follow Up Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr
- Primary Outcome Measures
Name Time Method Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity. Change from baseline to week 8 or 16 Part 1 - Blinded Treatment Period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
University of California
🇺🇸Los Angeles, California, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of California Davis Health
🇺🇸Sacramento, California, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Piedmont Healthcare Pulmonary & Critical Care Research
🇺🇸Austell, Georgia, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Loyola University
🇺🇸Chicago, Illinois, United States
The Lung Research Center (St. Luke's)
🇺🇸Chesterfield, Missouri, United States
Norton Pulmonary Specialists
🇺🇸Louisville, Kentucky, United States
Thomas Jefferson University Korman Respiratory Institute
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Utah Health Sciences
🇺🇸Salt Lake City, Utah, United States
Inova Heart and Vascular Institute Advanced Lung Disease Clinic
🇺🇸Falls Church, Virginia, United States
Pulmonary Associates of Richmond
🇺🇸Richmond, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States