A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
- Conditions
- Pulmonary HypertensionPulmonary Fibrosis
- Interventions
- Combination Product: INOpulse®Combination Product: Open Label ExtensionCombination Product: Placebo
- Registration Number
- NCT03267108
- Lead Sponsor
- Bellerophon Pulse Technologies
- Brief Summary
A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
- Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Nitric Oxide (iNO) INOpulse® Pulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr) Open Label Extension Open Label Extension Pulsed inhaled iNO 45 mcg/kg IBW/hr Placebo Placebo Pulsed inhaled N2, 99.999% gas
- Primary Outcome Measures
Name Time Method Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy Baseline to Month 4 Part 1 - Blinded Treatment Period
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy Baseline to Month 4 Part 2 - Open Label Extension (OLE)
- Secondary Outcome Measures
Name Time Method Time to Clinical Improvement Baseline to Month 4 Part 1 Blinded Treatment Period
Time to Clinical Worsening Baseline to Month 4 Part 1 - Blinded Treatment Period
Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total Baseline to Month 4 Part 1 Blinded Treatment Period: SGRQ is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)
Time to Clinical Deterioration Baseline to Month 4 Part 1 Blinded Treatment Period
Change in Overall Activity as Measured by Actigraphy Baseline to M4 Part 1 - Blinded Treatment Period
Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ) Baseline to Month 4 Part 1 Blinded Treatment Period: The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
Change in 6 Minute Walk Distance Baseline to Month 4 Part 1 Blinded Treatment Period
Trial Locations
- Locations (64)
Stanford University Medical Center
🇺🇸Stanford, California, United States
Amicis Research
🇺🇸Northridge, California, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Cleveland Clinic
🇺🇸Weston, Florida, United States
NYU Langone
🇺🇸New York, New York, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Atlantic Health Respiratory Institute
🇺🇸Summit, New Jersey, United States
Inova Heart and Vascular Institute Advanced Lung Disease Clinic
🇺🇸Falls Church, Virginia, United States
University of California San Francisco
🇺🇸Fresno, California, United States
University of California
🇺🇸Los Angeles, California, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Loyola University
🇺🇸Maywood, Illinois, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Pulmonix, LLC/LeBauer Cone Health
🇺🇸Greensboro, North Carolina, United States
Thomas Jefferson University Korman Respiratory Institute
🇺🇸Philadelphia, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Queen's University/Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Northwestern
🇺🇸Chicago, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
Ascension St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health Sciences
🇺🇸Salt Lake City, Utah, United States
Banner - University Medical Center Arizona
🇺🇸Phoenix, Arizona, United States
Arizona Pulmonary Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Piedmont Healthcare
🇺🇸Austell, Georgia, United States
North Shore University Hospital
🇺🇸Evanston, Illinois, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
National Jewish
🇺🇸Denver, Colorado, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
UC Denver Anschutz Medical Center
🇺🇸Aurora, Colorado, United States
University of California Davis Health
🇺🇸Sacramento, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Paloma Medical Group
🇺🇸Paloma, California, United States
St. Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
Advanced Pulmonary Research Institute
🇺🇸Loxahatchee Groves, Florida, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Metroplex Pulmonary and Sleep
🇺🇸McKinney, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Norton Pulmonary Specialists
🇺🇸Louisville, Kentucky, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
The University of North Carolina at Chapel Hill Marsico Clinical Research Center
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Pulmonary Associates of Richmond
🇺🇸Richmond, Virginia, United States