Study Stopped
The trial did not meet its primary endpoint, hence was terminated due to futility.
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
REBUILD
A 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 of Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) - REBUILD
1 other identifier
interventional
145
2 countries
64
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2020
Typical duration for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 27, 2023
July 1, 2023
2.5 years
August 27, 2017
July 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
Part 1 - Blinded Treatment Period
Baseline to Month 4
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy
Part 2 - Open Label Extension (OLE)
Baseline to Month 4
Secondary Outcomes (7)
Change in Overall Activity as Measured by Actigraphy
Baseline to M4
Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
Baseline to Month 4
Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total
Baseline to Month 4
Time to Clinical Worsening
Baseline to Month 4
Time to Clinical Deterioration
Baseline to Month 4
- +2 more secondary outcomes
Study Arms (3)
Inhaled Nitric Oxide (iNO)
ACTIVE COMPARATORPulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Placebo
PLACEBO COMPARATORPulsed inhaled N2, 99.999% gas
Open Label Extension
OTHERPulsed inhaled iNO 45 mcg/kg IBW/hr
Interventions
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Eligibility Criteria
You may qualify if:
- 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)
- +6 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
University of Alabama
Birmingham, Alabama, 35294, United States
Banner - University Medical Center Arizona
Phoenix, Arizona, 85006, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85012, United States
University of California San Francisco
Fresno, California, 93701, United States
University of California
Los Angeles, California, 90024, United States
Amicis Research
Northridge, California, 91324, United States
Paloma Medical Group
Paloma, California, 92675, United States
University of California Davis Health
Sacramento, California, 95817, United States
Stanford University Medical Center
Stanford, California, 94305, United States
UC Denver Anschutz Medical Center
Aurora, Colorado, 80046, United States
National Jewish
Denver, Colorado, 80206, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, 33765, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470, United States
University of Miami
Miami, Florida, 33125, United States
Avanza Medical Research Center
Pensacola, Florida, 32503, United States
University of South Florida
Tampa, Florida, 33612, United States
Cleveland Clinic
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Piedmont Healthcare
Austell, Georgia, 30106, United States
Northwestern
Chicago, Illinois, 60611, United States
North Shore University Hospital
Evanston, Illinois, 60201, United States
Loyola University
Maywood, Illinois, 60153, United States
Southern Illinois University
Springfield, Illinois, 62702 / 62794, United States
Ascension St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
Creighton University
Omaha, Nebraska, 68124, United States
Atlantic Health Respiratory Institute
Summit, New Jersey, 07901, United States
NYU Langone
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
The University of North Carolina at Chapel Hill Marsico Clinical Research Center
Chapel Hill, North Carolina, 27517, United States
Pulmonix, LLC/LeBauer Cone Health
Greensboro, North Carolina, 27403, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
The Oregon Clinic
Portland, Oregon, 97220, United States
Thomas Jefferson University Korman Respiratory Institute
Philadelphia, Pennsylvania, 19017, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15123, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Metroplex Pulmonary and Sleep
McKinney, Texas, 75069, United States
University of Utah Health Sciences
Salt Lake City, Utah, 84108, United States
Inova Heart and Vascular Institute Advanced Lung Disease Clinic
Falls Church, Virginia, 22042, United States
Pulmonary Associates of Richmond
Richmond, Virginia, 23229, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
Queen's University/Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
London Health Sciences Centre
London, Ontario, K7L 2V6, Canada
Related Publications (1)
Nathan SD, Rajicic N, Dudenhofer R, Hussain R, Argula R, Bandyopadhyay D, Luckhardt T, Muehlemann N, Flaherty KR, Glassberg MK, Lancaster L, Raghu G, Fernandes P. Inhaled Nitric Oxide in Fibrotic Lung Disease: A Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2024 Dec;21(12):1661-1669. doi: 10.1513/AnnalsATS.202406-662OC.
PMID: 39141673DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ashika Ahmed
Bellerophon Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2017
First Posted
August 30, 2017
Study Start
December 14, 2020
Primary Completion
June 9, 2023
Study Completion
June 30, 2023
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share