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A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

Study Purpose

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

Recruitment Criteria

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
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - A high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using guidelines, as per American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT): - Major IIPs (idiopathic interstitial pneumonias) 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.
  • - Connective Tissue Disease associated with IPF (CTD-ILD) - Interstitial Pneumonia with Autoimmune Features (IPAF) - Have been using oxygen therapy by nasal cannula for at least 4 weeks (including use limited to exertion) - 6MWD ≥ 100 meters and ≤ 400 meters at screening and Baseline/Randomization visits.
  • - World Health Organization (WHO) Functional Class II-IV.
  • - Forced Vital Capacity ≥ 40% predicted within the 60 day Screening period.
  • - Age between 18 and 80 years (inclusive) at screening.

Exclusion criteria:

  • - For women of child-bearing potential: Pregnant or breastfeeding females at Screening, or planning to get pregnant, or unwilling to use appropriate contraception if sexually active to avoid pregnancy during the study and for at least 30 days after discontinuation of the study drug.
  • - Heart failure with reduced ejection fraction (HFrEF; systolic heart failure) with an ejection fraction of < 40%; or severe HF with preserved EF (HFpEF; diastolic HF) - History of sarcoidosis.
  • - History of chronic thrombo-embolic pulmonary hypertension (CTEPH; WHO group 4 PH) - Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
  • - Body mass index (BMI) >40 kg/m2 at screening.
  • - Intermittent uncontrolled atrial fibrillation, in the opinion of the Principal Investigator.
  • - Known severe hepatic impairment, in the opinion of the Principal Investigator.
- Known severe renal impairment (Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) 2009 equation [Levy 2009] calculated creatinine clearance <30 ml/min) at screening

Trial Details

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 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.

 Ashika Ahmed
Principal Investigator Affiliation Bellerophon Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Fibrosis, Pulmonary Hypertension
Study Website: View Trial Website
Additional Details

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

Arms & Interventions

Arms

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

Interventions

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.

Contact a Trial Team

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.

University of Alabama, Birmingham, Alabama

Status

Address

University of Alabama

Birmingham, Alabama, 35294

Phoenix, Arizona

Status

Address

Banner - University Medical Center Arizona

Phoenix, Arizona, 85006

Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona

Status

Address

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012

University of California San Francisco, Fresno, California

Status

Address

University of California San Francisco

Fresno, California, 93701

University of California, Los Angeles, California

Status

Address

University of California

Los Angeles, California, 90024

Amicis Research, Northridge, California

Status

Address

Amicis Research

Northridge, California, 91324

Paloma Medical Group, Paloma, California

Status

Address

Paloma Medical Group

Paloma, California, 92675

University of California Davis Health, Sacramento, California

Status

Address

University of California Davis Health

Sacramento, California, 95817

Stanford University Medical Center, Stanford, California

Status

Address

Stanford University Medical Center

Stanford, California, 94305

UC Denver Anschutz Medical Center, Aurora, Colorado

Status

Address

UC Denver Anschutz Medical Center

Aurora, Colorado, 80046

National Jewish, Denver, Colorado

Status

Address

National Jewish

Denver, Colorado, 80206

Georgetown University, Washington, District of Columbia

Status

Address

Georgetown University

Washington, District of Columbia, 20007

Clearwater, Florida

Status

Address

St. Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765

Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida

Status

Address

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, 33470

University of Miami, Miami, Florida

Status

Address

University of Miami

Miami, Florida, 33125

Avanza Medical Research Center, Pensacola, Florida

Status

Address

Avanza Medical Research Center

Pensacola, Florida, 32503

University of South Florida, Tampa, Florida

Status

Address

University of South Florida

Tampa, Florida, 33612

Cleveland Clinic, Weston, Florida

Status

Address

Cleveland Clinic

Weston, Florida, 33331

Emory University, Atlanta, Georgia

Status

Address

Emory University

Atlanta, Georgia, 30322

Northside Hospital, Atlanta, Georgia

Status

Address

Northside Hospital

Atlanta, Georgia, 30342

Piedmont Healthcare, Austell, Georgia

Status

Address

Piedmont Healthcare

Austell, Georgia, 30106

Northwestern, Chicago, Illinois

Status

Address

Northwestern

Chicago, Illinois, 60611

North Shore University Hospital, Evanston, Illinois

Status

Address

North Shore University Hospital

Evanston, Illinois, 60201

Loyola University, Maywood, Illinois

Status

Address

Loyola University

Maywood, Illinois, 60153

Southern Illinois University, Springfield, Illinois

Status

Address

Southern Illinois University

Springfield, Illinois, 62702 / 62794

Ascension St. Vincent Hospital, Indianapolis, Indiana

Status

Address

Ascension St. Vincent Hospital

Indianapolis, Indiana, 46260

Norton Pulmonary Specialists, Louisville, Kentucky

Status

Address

Norton Pulmonary Specialists

Louisville, Kentucky, 40202

University of Louisville, Louisville, Kentucky

Status

Address

University of Louisville

Louisville, Kentucky, 40202

Johns Hopkins Hospital, Baltimore, Maryland

Status

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21205

Tufts Medical Center, Boston, Massachusetts

Status

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

University of Michigan, Ann Arbor, Michigan

Status

Address

University of Michigan

Ann Arbor, Michigan, 48109

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

The Lung Research Center, LLC, Chesterfield, Missouri

Status

Address

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

Creighton University, Omaha, Nebraska

Status

Address

Creighton University

Omaha, Nebraska, 68124

Atlantic Health Respiratory Institute, Summit, New Jersey

Status

Address

Atlantic Health Respiratory Institute

Summit, New Jersey, 07901

NYU Langone, New York, New York

Status

Address

NYU Langone

New York, New York, 10016

Mount Sinai Hospital, New York, New York

Status

Address

Mount Sinai Hospital

New York, New York, 10029

Weill Cornell Medical Center, New York, New York

Status

Address

Weill Cornell Medical Center

New York, New York, 10065

Stony Brook University Hospital, Stony Brook, New York

Status

Address

Stony Brook University Hospital

Stony Brook, New York, 11794

Chapel Hill, North Carolina

Status

Address

The University of North Carolina at Chapel Hill Marsico Clinical Research Center

Chapel Hill, North Carolina, 27517

Pulmonix, LLC/LeBauer Cone Health, Greensboro, North Carolina

Status

Address

Pulmonix, LLC/LeBauer Cone Health

Greensboro, North Carolina, 27403

University of Cincinnati, Cincinnati, Ohio

Status

Address

University of Cincinnati

Cincinnati, Ohio, 45267

University Hospitals, Cleveland, Ohio

Status

Address

University Hospitals

Cleveland, Ohio, 44106

The Ohio State University, Columbus, Ohio

Status

Address

The Ohio State University

Columbus, Ohio, 43210

The Oregon Clinic, Portland, Oregon

Status

Address

The Oregon Clinic

Portland, Oregon, 97220

Philadelphia, Pennsylvania

Status

Address

Thomas Jefferson University Korman Respiratory Institute

Philadelphia, Pennsylvania, 19017

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Temple University, Philadelphia, Pennsylvania

Status

Address

Temple University

Philadelphia, Pennsylvania, 19140

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15123

AnMed Health, Anderson, South Carolina

Status

Address

AnMed Health

Anderson, South Carolina, 29621

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Baylor University Medical Center, Dallas, Texas

Status

Address

Baylor University Medical Center

Dallas, Texas, 75246

UT Southwestern Medical Center, Dallas, Texas

Status

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Houston, Texas

Status

Address

University of Texas Health Science Center at Houston

Houston, Texas, 77030

Metroplex Pulmonary and Sleep, McKinney, Texas

Status

Address

Metroplex Pulmonary and Sleep

McKinney, Texas, 75069

University of Utah Health Sciences, Salt Lake City, Utah

Status

Address

University of Utah Health Sciences

Salt Lake City, Utah, 84108

Falls Church, Virginia

Status

Address

Inova Heart and Vascular Institute Advanced Lung Disease Clinic

Falls Church, Virginia, 22042

Pulmonary Associates of Richmond, Richmond, Virginia

Status

Address

Pulmonary Associates of Richmond

Richmond, Virginia, 23229

University of Washington Medical Center, Seattle, Washington

Status

Address

University of Washington Medical Center

Seattle, Washington, 98195

International Sites

University of British Columbia, Vancouver, British Columbia, Canada

Status

Address

University of British Columbia

Vancouver, British Columbia, V5Z 1M9

Queen's University/Hotel Dieu Hospital, Kingston, Ontario, Canada

Status

Address

Queen's University/Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2

London Health Sciences Centre, London, Ontario, Canada

Status

Address

London Health Sciences Centre

London, Ontario, K7L 2V6

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