A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. (REBUILD)
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 80 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03267108 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2/Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bellerophon Pulse Technologies |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Wassim Fares, MD, MSc |
Principal Investigator Affiliation | Bellerophon Therapeutics |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Fibrosis, Pulmonary Hypertension |
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) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. (REBUILD)
Active Comparator: Inhaled Nitric Oxide (iNO)
Pulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Placebo Comparator: Placebo
Pulsed inhaled N2, 99.999% gas
Other: Open Label Extension
Pulsed inhaled iNO 45 mcg/kg IBW/hr
Combination Product: - INOpulse
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Combination Product: - Placebo
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Combination Product: - Open Label Extension
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85012
Status
Recruiting
Address
Amicus Research
Northridge, California, 91324
Status
Active, not recruiting
Address
University of California Davis Health
Sacramento, California, 95817
Status
Recruiting
Address
UC Denver Anschutz Medical Center
Aurora, Colorado, 80046
Status
Recruiting
Address
St. Franics Sleep Allergy and Lung Institute
Clearwater, Florida, 33765
Status
Recruiting
Address
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
Status
Active, not recruiting
Address
University of Miami
Miami, Florida, 33125
Status
Recruiting
Address
Emory University
Atlanta, Georgia, 30322
Status
Recruiting
Address
Piedmont Healthcare
Austell, Georgia, 30106
Status
Recruiting
Address
Loyola University
Chicago, Illinois, 60153
Status
Recruiting
Address
Southern Illinois University
Springfield, Illinois, 62702 / 62794
Status
Active, not recruiting
Address
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Active, not recruiting
Address
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
Status
Active, not recruiting
Address
The University of North Carolina at Chapel Hill Marsico Clinical Research Center
Chapel Hill, North Carolina, 27517
Status
Recruiting
Address
University of Cincinnati
Cincinnati, Ohio, 45267
Status
Recruiting
Address
Thomas Jefferson University Korman Respiratory Institute
Philadelphia, Pennsylvania, 19017
Status
Recruiting
Address
Temple University
Philadelphia, Pennsylvania, 19140
Status
Active, not recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Active, not recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Active, not recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75390
Status
Active, not recruiting
Address
University of Utah Health Sciences
Salt Lake City, Utah, 84108
Status
Active, not recruiting
Address
Inova Heart and Vascular Institute Advanced Lung Disease Clinic
Falls Church, Virginia, 22042
Status
Recruiting
Address
Pulmonary Associates of Richmond
Richmond, Virginia, 23229
Status
Active, not recruiting
Address
University of Washington Medical Center
Seattle, Washington, 981195
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