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) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. (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:

  • - 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 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.
  • - Have been using oxygen therapy by nasal cannula for at least 4 weeks.
  • - 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 last 6 months prior to screening the screening run-in period.
  • - Age between 18 and 80 years (inclusive)

    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.
  • - A definitive diagnosis of a connective tissue disease (eg, systemic sclerosis, Lupus, Sjögren's, mixed CTD or other CTD's via ACR/EULAR classification criteria) - 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.
  • - Known permanent atrial fibrillation.
  • - 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 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
Additional Details

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)

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.

Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona

Status

Recruiting

Address

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012

Site Contact

Nidhi Samaraweera

nidhi-research@hotmail.com

602-271-0832

Amicus Research, Northridge, California

Status

Recruiting

Address

Amicus Research

Northridge, California, 91324

Site Contact

Tyrone Rosales

tyrone.rosales@amicisresearch.com

818-924-4708

University of California Davis Health, Sacramento, California

Status

Active, not recruiting

Address

University of California Davis Health

Sacramento, California, 95817

UC Denver Anschutz Medical Center, Aurora, Colorado

Status

Recruiting

Address

UC Denver Anschutz Medical Center

Aurora, Colorado, 80046

Site Contact

Cheryl Abbott, RN, CCRP

valerie.parker@bellerophon.com

303-724-7466

Clearwater, Florida

Status

Recruiting

Address

St. Franics Sleep Allergy and Lung Institute

Clearwater, Florida, 33765

Site Contact

nn Gove, RN, BA, CCRC

agove@stfrancismed.com

727-210-4606

Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida

Status

Recruiting

Address

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, 33470

Site Contact

Mila Moreira, MSN, APRN

aprinpmila@gmail.com

561-795-1022

University of Miami, Miami, Florida

Status

Active, not recruiting

Address

University of Miami

Miami, Florida, 33125

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Site Contact

Mitzi Near

mnear@emory.edu

404-712-9603

Piedmont Healthcare, Austell, Georgia

Status

Recruiting

Address

Piedmont Healthcare

Austell, Georgia, 30106

Site Contact

Aja Bowser

Aja.Bowser@piedmont.org

770-745-1404 #2

Loyola University, Chicago, Illinois

Status

Recruiting

Address

Loyola University

Chicago, Illinois, 60153

Site Contact

Josefina Corral

Jcorral@luc.edu

708-216-5744

Southern Illinois University, Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University

Springfield, Illinois, 62702 / 62794

Site Contact

Lori Miedwig, MA, CCRP

lmiedwig@siumed.edu

217-545-4402

Kentuckiana Pulmonary Associates, Louisville, Kentucky

Status

Active, not recruiting

Address

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Courtney Graft

ccgraft@med.umich.edu

734-272-2144

The Lung Research Center, LLC, Chesterfield, Missouri

Status

Active, not recruiting

Address

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

Chapel Hill, North Carolina

Status

Active, not recruiting

Address

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

Chapel Hill, North Carolina, 27517

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Alexandria Davis

davis5ax@ucmail.uc.edu

513-558-2148

Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Korman Respiratory Institute

Philadelphia, Pennsylvania, 19017

Site Contact

Tamra Perez

tamra.perez@jefferson.edu

215-955-9181

Temple University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Site Contact

Delores Fehrle

delores.fehrle@tuhs.temple.edu

215-707-4260

Medical University of South Carolina, Charleston, South Carolina

Status

Active, not recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Active, not recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

UT Southwestern Medical Center, Dallas, Texas

Status

Active, not recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

University of Utah Health Sciences, Salt Lake City, Utah

Status

Active, not recruiting

Address

University of Utah Health Sciences

Salt Lake City, Utah, 84108

Falls Church, Virginia

Status

Active, not recruiting

Address

Inova Heart and Vascular Institute Advanced Lung Disease Clinic

Falls Church, Virginia, 22042

Pulmonary Associates of Richmond, Richmond, Virginia

Status

Recruiting

Address

Pulmonary Associates of Richmond

Richmond, Virginia, 23229

Site Contact

Laura Lincoln

valerie.parker@bellerophon.com

804-288-5945

University of Washington Medical Center, Seattle, Washington

Status

Active, not recruiting

Address

University of Washington Medical Center

Seattle, Washington, 981195

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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