A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
NCT ID: NCT05747508
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
85 participants
INTERVENTIONAL
2017-12-29
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inhaled Nitric Oxide (iNO)
Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr)
INOpulse®
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Placebo
Pulsed inhaled N2, 99.999% gas
Placebo
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Long Term Follow Up
Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr
Long Term Follow Up
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Interventions
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INOpulse®
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Placebo
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Long Term Follow Up
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Bellerophon
INDUSTRY
Responsible Party
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Principal Investigators
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Ashika Ahmed, MD
Role: STUDY_DIRECTOR
Bellerophon Therapeutics
Locations
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Arizona Pulmonary Specialists
Phoenix, Arizona, United States
University of California
Los Angeles, California, United States
University of California Davis Health
Sacramento, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Emory University
Atlanta, Georgia, United States
Piedmont Healthcare Pulmonary & Critical Care Research
Austell, Georgia, United States
Loyola University
Chicago, Illinois, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
The Lung Research Center (St. Luke's)
Chesterfield, Missouri, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Thomas Jefferson University Korman Respiratory Institute
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 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
Countries
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Other Identifiers
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PULSE-PHPF-001 Phase 2
Identifier Type: -
Identifier Source: org_study_id