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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) 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.

Edward Parsley, DO
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

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) 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.

University of Alabama, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama

Birmingham, Alabama, 35294

Site Contact

Brittany Harrison

bnrouse@uabmc.edu

205-934-4440

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

Amicis Research, Northridge, California

Status

Recruiting

Address

Amicis Research

Northridge, California, 91324

Site Contact

Fernando Hernandez

f.hernandez@amicisresearch.com

818-470-9212

Paloma Medical Group, Paloma, California

Status

Recruiting

Address

Paloma Medical Group

Paloma, California, 92675

Site Contact

Max Briles

max@palomamedical.com

949-878-0079

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

allison.gladden@bellerophon.com

303-724-7466

Clearwater, Florida

Status

Recruiting

Address

St. Franics Sleep Allergy and Lung Institute

Clearwater, Florida, 33765

Site Contact

Ann 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

Recruiting

Address

University of Miami

Miami, Florida, 33125

Site Contact

Isabel Jaraba

ijaraba@med.miami.edu

305-243-2568 #3

Avanza Medical Research Center, Pensacola, Florida

Status

Recruiting

Address

Avanza Medical Research Center

Pensacola, Florida, 32503

Site Contact

Crystal Crump

c.crump@avanzaresearch.com

850-972-9324

University of South Florida, Tampa, Florida

Status

Recruiting

Address

University of South Florida

Tampa, Florida, 33612

Site Contact

Kirsten Grube

klgrube@usf.edu

813-844-8624

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Site Contact

Mitzi Near

mnear@emory.edu

404-712-9603

Northside Hospital, Atlanta, Georgia

Status

Recruiting

Address

Northside Hospital

Atlanta, Georgia, 30342

Site Contact

Tamara Wakhisi

tamara.wakhisi@northside.com

404-236-8322

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

Ascension St. Vincent Hospital, Indianapolis, Indiana

Status

Recruiting

Address

Ascension St. Vincent Hospital

Indianapolis, Indiana, 46260

Site Contact

Diane Slama

diane.slama@ascension.org

317-338-6717

Norton Pulmonary Specialists, Louisville, Kentucky

Status

Recruiting

Address

Norton Pulmonary Specialists

Louisville, Kentucky, 40202

Site Contact

Kimberly Robinson

Kimberly.Robinson@nortonhealthcare.org

502-587-8000

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

Recruiting

Address

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

Site Contact

Anna Shipp, RRT

Anna.Shipp@stlukes-stl.com

314-682-3653

Creighton University, Omaha, Nebraska

Status

Recruiting

Address

Creighton University

Omaha, Nebraska, 68124

Site Contact

Theresa Ramelb

TheresaRamelb@creighton.edu

402-280-4142

Atlantic Respiratory Institute, Summit, New Jersey

Status

Recruiting

Address

Atlantic Respiratory Institute

Summit, New Jersey, 07901

Site Contact

Marissa Rienton-Lim, MD, CCRC

Marissa.Rienton-Lim@atlantichealth.org

862-345-4842

NYU Langone, New York, New York

Status

Recruiting

Address

NYU Langone

New York, New York, 10016

Site Contact

Anabela Barroso

anabela.barroso@nyulangone.org

212-263-9189

Stony Brook University Hospital, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University Hospital

Stony Brook, New York, 11794

Site Contact

Jackie Skarre, MS, RN

Jacqueline.Skarre@stonybrookmedicine.edu

631-444-9033

Chapel Hill, North Carolina

Status

Recruiting

Address

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

Chapel Hill, North Carolina, 27517

Site Contact

Paula Glover

bpglover@live.unc.edu

908.574.4859

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Rebecca Ingledue

ingledra@ucmail.uc.edu

513-558-0027

Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Korman Respiratory Institute

Philadelphia, Pennsylvania, 19017

Site Contact

Lori Reardon

Lori.reardon@jefferson.edu

404-451-5137

Temple University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Site Contact

Delores Fehrle

delores.fehrle@tuhs.temple.edu

215-707-4260

AnMed Health, Anderson, South Carolina

Status

Recruiting

Address

AnMed Health

Anderson, South Carolina, 29621

Site Contact

Andrea Franks

andrea.franks@anmedhealth.org

864-512-8551

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Angel Darrow

darrow@musc.edu

843-792-8092

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

James Del Greco, MSN, RN

james.del.greco@vanderbilt.edu

615-343-7068

Baylor University Medical Center, Dallas, Texas

Status

Recruiting

Address

Baylor University Medical Center

Dallas, Texas, 75246

Site Contact

Eva Patel

Eva.Patel@BSWHealth.org

214-820-5829

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Kirstie Ledoux

Kirstie.LeDoux@UTSouthwestern.edu

214-645-6605

Metroplex Pulmonary and Sleep, McKinney, Texas

Status

Recruiting

Address

Metroplex Pulmonary and Sleep

McKinney, Texas, 75069

Site Contact

Ambreen Ahmed,, MBBS

aahmed@mpsleepcenter.com

972-838-1892

University of Utah Health Sciences, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Sciences

Salt Lake City, Utah, 84108

Site Contact

Joseph Martinez

Joseph.Martinez@utah.edu

801-581-5811

Falls Church, Virginia

Status

Recruiting

Address

Inova Heart and Vascular Institute Advanced Lung Disease Clinic

Falls Church, Virginia, 22042

Site Contact

Priscila Dauphin

priscila.dauphin@inova.org

703-776-7128

Pulmonary Associates of Richmond, Richmond, Virginia

Status

Recruiting

Address

Pulmonary Associates of Richmond

Richmond, Virginia, 23229

Site Contact

Betsy Daniel

bdaniel@paraccess.com

804-396-4421

University of Washington Medical Center, Seattle, Washington

Status

Active, not recruiting

Address

University of Washington Medical Center

Seattle, Washington, 981195