A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed iNO in Subjects With Pulmonary Fibrosis

Study Purpose

A phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in subjects with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2).

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 - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed Informed Consent 2. 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 3.
At least 50% of the subjects will have confirmed intermediate or high probability of pulmonary hypertension as determined by echocardiography according to the 2015 ESC/ERS Guidelines for Diagnosis and Treatment of Pulmonary Hypertension. 4. Have been using oxygen therapy by nasal cannula for at least 4 weeks prior to the screening run-in period. 5. 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization 6. WHO Functional Class II-IV 7. Forced Vital Capacity ≥ 40% predicted within last 6 months prior to screening the screening run-in period. 8. For at least 1 week prior to Baseline/Randomization, subjects must demonstrate the ability to consistently use the device greater than 12 hrs/day in the opinion of the Investigator. 9. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female subjects should take adequate precaution to avoid pregnancy. 10. Subjects must have completed at least 1 week of activity monitoring prior to the Baseline/Randomization visit. 11. Age between 18 and 85 years (inclusive) 12. Subject should be clinically stable for at least 4 weeks prior to Baseline/Randomization in the opinion of the Principal Investigator.

Exclusion Criteria:

1. Demonstrate symptomatic rebound defined as significant cardiopulmonary instability, such as systemic arterial oxygen desaturation, hypoxemia, bradycardia, tachycardia, systemic hypotension, shortness of breath, near-syncope, and syncope, occurring within 1 hour of acute iNO during rebound testing 2. Episodes of disease worsening within 1 month prior to Baseline/Randomization 3. Use of any PAH-specific medications regardless of reason for use 4. Acute or chronic physical impairment (other than dyspnea due to PF) that would limit the ability to comply with study procedures or adherence to therapy (i.e., 6MWT), including carrying and wearing the pulsed delivery device per study protocol, or medical problem(s) likely to preclude completion of the study 5. Pregnant or breastfeeding females at Screening 6. Administered L-arginine within 1 month prior to Screening 7. The concurrent use of the INOpulse device with a continuous positive airway pressure (CPAP), Bilevel positive airway pressure (BPAP), or any other positive pressure device. 8. Use of investigational drugs or devices within 1 month prior to Screening (other than acute vasodilator testing with iNO) 9. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study including unable to complete 6MWT. 10. Any subject who has been enrolled in any previous clinical study with inhaled NO administered through pulse delivery 11. In the last 6 months prior to screening, evidence of any connective tissue disease with FVC > 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the Investigator 12. Evidence of clinically significant Combined Pulmonary Fibrosis and Emphysema (CPFE) if > 15% of lung fields by CT scan show evidence of emphysema in the opinion of the Investigator

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
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.

Hunter Gillies, MD
Principal Investigator Affiliation Bellerophon Therapeutics
Agency Class

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

IndustryIndustry
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 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2).

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.

Pulmonary Associates of Richmond, Richmond, Virginia

Status

Recruiting

Address

Pulmonary Associates of Richmond

Richmond, Virginia, 23229

Site Contact

Laura Lincoln

nick.niles@bellerohphon.com

804-288-5945

Falls Church, Virginia

Status

Recruiting

Address

Inova Heart and Vascular Institute Advanced Lung Disease Clinic

Falls Church, Virginia, 22042

Site Contact

Serina Zorrilla, RN

serina.zorrilla@inova.org

703-776-6147

University of Utah Health Sciences, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Sciences

Salt Lake City, Utah, 84108

Site Contact

Scott Sweeten

nick.niles@bellerohphon.com

801-581-5811

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Oluwatosin Igenoza

oluwatosin.igenoza@utsouthwestern.edu

214-645-6493

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

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

Temple University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Site Contact

Delores Fehrle

delores.fehrle@tuhs.temple.edu

215-707-4260

Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Korman Respiratory Institute

Philadelphia, Pennsylvania, 19017

Site Contact

Tamra Perez

nick.niles@bellerohphon.com

215-955-9181

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

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

Samantha Earnhardt

samantha_earnhardt@med.unc.edu

984-974-2972

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Hannah Perkins

hperkins@wustl.edu

314-362-9919

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

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Linda Briggs

briggsl@med.umich.edu

734-232-5844

Massachusetts General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Lloyd Liang

nick.niles@bellerohphon.com

617-724-5518

Kentuckiana Pulmonary Associates, Louisville, Kentucky

Status

Recruiting

Address

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202

Site Contact

Kimberly Robinson

krobinson@kpadocs.com

502-587-8000

Loyola University, Chicago, Illinois

Status

Recruiting

Address

Loyola University

Chicago, Illinois, 60153

Site Contact

Josefina Corral

Jcorral@luc.edu

708-216-5744

Marietta, Georgia

Status

Recruiting

Address

Wellstar Medical Group - Pulmonary Medicine

Marietta, Georgia, 30060

Site Contact

Laura Murphy

nick.niles@bellerohphon.com

470-793-4046

Piedmont Healthcare, Austell, Georgia

Status

Recruiting

Address

Piedmont Healthcare

Austell, Georgia, 30106

Site Contact

Aja Bowser

Aja.Bowser@piedmont.org

770-745-1404 #2

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Site Contact

Mitzi Near

mitzi.near@emory.edu

404-712-9603

Avanza Medical Research Center, Pensacola, Florida

Status

Not yet recruiting

Address

Avanza Medical Research Center

Pensacola, Florida, 32503

Site Contact

Ashley Corlies

a.corlies@avanzaresearch.com

850-972-9322

Central Florida Pulmonary Group, Orlando, Florida

Status

Withdrawn

Address

Central Florida Pulmonary Group

Orlando, Florida, 33136

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33125

Site Contact

Emmanuelle Simonet, MA, CCRP

nick.niles@bellerohphon.com

305-243-9383

National Jewish Health, Denver, Colorado

Status

Active, not recruiting

Address

National Jewish Health

Denver, Colorado, 80206

UC Denver Anschutz Medical Center, Aurora, Colorado

Status

Recruiting

Address

UC Denver Anschutz Medical Center

Aurora, Colorado, 80046

Site Contact

Cheryl Abbott, RN, CCRP

nick.niles@bellerohphon.com

303-724-7466

University of California Davis Health, Sacramento, California

Status

Recruiting

Address

University of California Davis Health

Sacramento, California, 95817

Site Contact

Macey Sockolov, CCRP

mlsockolov@ucdavis.edu

916-734-1554

David Geffen School of Medicine at UCLA, Los Angeles, California

Status

Not yet recruiting

Address

David Geffen School of Medicine at UCLA

Los Angeles, California, 90024

Site Contact

Lynne Yoder

lyoder@mednet.ucla.edu

310-794-3299

Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona

Status

Recruiting

Address

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012

Site Contact

Kelly Jenkins

nick.niles@bellerohphon.com

602-271-0832

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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