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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03267108
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )

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

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Pulmonary Hypertension Combination Product: INOpulse® Combination Product: Placebo Combination Product: Open Label Extension Phase 3

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Inhaled Nitric Oxide (iNO)
Pulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Combination Product: INOpulse®
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.

Placebo Comparator: Placebo
Pulsed inhaled N2, 99.999% gas
Combination Product: Placebo
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.

Open Label Extension
Pulsed inhaled iNO 45 mcg/kg IBW/hr
Combination Product: Open Label Extension
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.




Primary Outcome Measures :
  1. Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy [ Time Frame: Baseline to Month 4 ]
    Part 1 - Blinded Treatment Period

  2. Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy [ Time Frame: Baseline to Month 4 ]
    Part 2 - Open Label Extension (OLE)


Secondary Outcome Measures :
  1. Change in Overall Activity as Measured by Actigraphy [ Time Frame: Baseline to M4 ]
    Part 1 - Blinded Treatment Period

  2. Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ) [ Time Frame: Baseline to Month 4 ]
    Part 1 Blinded Treatment Period: The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).

  3. Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total [ Time Frame: Baseline to Month 4 ]
    Part 1 Blinded Treatment Period: SGRQ is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)

  4. Time to Clinical Worsening [ Time Frame: Baseline to Month 4 ]
    Part 1 - Blinded Treatment Period

  5. Time to Clinical Deterioration [ Time Frame: Baseline to Month 4 ]
    Part 1 Blinded Treatment Period

  6. Time to Clinical Improvement [ Time Frame: Baseline to Month 4 ]
    Part 1 Blinded Treatment Period

  7. Change in 6 Minute Walk Distance [ Time Frame: Baseline to Month 4 ]
    Part 1 Blinded Treatment Period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267108


Contacts
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Contact: Allison Gladden 908.574.4859 allison.gladden@bellerophon.com
Contact: Valerie Parker 908.574.4713 valerie.parker@bellerophon.com

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Brittany Harrison    205-934-4440    bnrouse@uabmc.edu   
United States, Arizona
Arizona Pulmonary Specialists, Ltd. Recruiting
Phoenix, Arizona, United States, 85012
Contact: Nidhi Samaraweera    602-271-0832    nidhi-research@hotmail.com   
United States, California
Amicis Research Recruiting
Northridge, California, United States, 91324
Contact: Harvey Rosales    818-644-2242    harvey.rosales@amicusresearch.com   
Paloma Medical Group Recruiting
Paloma, California, United States, 92675
Contact: Michael Gloriani    949-637-8088    michael.g@palomamedical.com   
University of California Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Cynthia Perry-Baker    916-734-1554    clpbaker@ucdavis.edu   
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Hanna Gratny       hgratny@stanford.edu   
United States, Colorado
UC Denver Anschutz Medical Center Recruiting
Aurora, Colorado, United States, 80046
Contact: F Danielle Peacock    303-724-7466    frances.peacock@cuanschutz.edu   
National Jewish Recruiting
Denver, Colorado, United States, 80206
Contact: Jennifer Underwood    303-398-1518    UnderwoodJ@NJHealth.org   
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Amen Hamed    202-444-0895    amen.m.hamed@gunet.georgetown.edu   
United States, Florida
St. Franics Sleep Allergy and Lung Institute Recruiting
Clearwater, Florida, United States, 33765
Contact: Ryan Averill    727-210-4606    rfaverill@stfrancis.med.com   
Advanced Pulmonary Research Institute Recruiting
Loxahatchee Groves, Florida, United States, 33470
Contact: Mila Moreira, MSN, APRN    561-795-1022    aprinpmila@gmail.com   
University of Miami Recruiting
Miami, Florida, United States, 33125
Contact: Emilia Faraj-Hernandez    305-243-2568 ext 3    enf16@med.miami.edu   
Avanza Medical Research Center Recruiting
Pensacola, Florida, United States, 32503
Contact: Amanda Hiller    850-898-2182    A.hiller@avanzaresearch.com   
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Danielle Liebenow    813-844-8624    dliebenow@usf.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mitzi Near    404-712-9603    mnear@emory.edu   
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Nancy Bryant    404-236-8351    Nancy.Bryant@northside.com   
Piedmont Healthcare Recruiting
Austell, Georgia, United States, 30106
Contact: Olayinka Elemide    404-670-5361    Olayinka.elemide@piedmont.org   
United States, Illinois
Loyola University Recruiting
Chicago, Illinois, United States, 60153
Contact: Josefina Corral    708-216-5744    Jcorral@luc.edu   
North Shore University Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Naomi Ben-Israel Olive       NBenIsraelOlive@northshore.org   
Southern Illinois University Recruiting
Springfield, Illinois, United States, 62702 / 62794
Contact: Lori Miedwig, MA, CCRP    217-545-4402    lmiedwig@siumed.edu   
United States, Indiana
Ascension St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Diane Slama    317-338-6717    diane.slama@ascension.org   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Debra Gleason    859-330-0092    debra.gleason@uky.edu   
Norton Pulmonary Specialists Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kimberly Robinson    502-587-8000    Kimberly.Robinson@nortonhealthcare.org   
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sarah Collins    410-550-2062    shirsh1@jhmi.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Courtney Graft    734-272-2144    ccgraft@med.umich.edu   
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Jacqueline Day    313-916-1254    jday5@hfhs.org   
United States, Missouri
The Lung Research Center, LLC Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Anna Shipp, RRT    314-682-3653    Anna.Shipp@stlukes-stl.com   
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68124
Contact: Theresa Ramelb    402-280-4142    TheresaRamelb@creighton.edu   
United States, New Jersey
Atlantic Respiratory Institute Recruiting
Summit, New Jersey, United States, 07901
Contact: Marissa Rienton-Lim, MD, CCRC    862-345-4842    Marissa.Rienton-Lim@atlantichealth.org   
Contact: Beverly Obispo    862-345-4842    Beverly.Obispo@atlantichealth.org   
United States, New York
NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Anabela Barroso    212-263-9189    anabela.barroso@nyulangone.org   
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Alicia Morris    646-962-2741    ajm2017@med.cornell.edu   
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Jackie Skarre, MS, RN    631-444-9033    Jacqueline.Skarre@stonybrookmedicine.edu   
United States, North Carolina
The University of North Carolina at Chapel Hill Marsico Clinical Research Center Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Paula Glover       bpglover@live.unc.edu   
Pulmonix Not yet recruiting
Greensboro, North Carolina, United States, 27403
Contact: Jennifer Castillo    336-522-8871    jennifer.castillo@pulmonix.com   
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Emillie Hoh       hohek@ucmail.uc.edu   
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Xiuhua Yuan    216-844-2371    Xiuhua.Yuan@Uhhospitals.org   
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Alec Vest    419-786-8626    alec.vest@osumc.edu   
United States, Oregon
The Oregon Clinic Recruiting
Portland, Oregon, United States, 97220
Contact: Meg Day, CCRP    503-963-3182    mday@orclinic.com   
United States, Pennsylvania
Thomas Jefferson University Korman Respiratory Institute Recruiting
Philadelphia, Pennsylvania, United States, 19017
Contact: Disha Singh    215-955-3838    Disha.singh@jefferson.edu   
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Delores Fehrle    215-707-4260    delores.fehrle@tuhs.temple.edu   
United States, South Carolina
AnMed Health Recruiting
Anderson, South Carolina, United States, 29621
Contact: Andrea Franks    864-512-8551    andrea.franks@anmedhealth.org   
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kim Spencer    843-792-6890    spencer@musc.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: James Del Greco, MSN, RN    615-343-7068    james.del.greco@vanderbilt.edu   
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Eva Patel    214-820-5829    Eva.Patel@BSWHealth.org   
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kirstie Ledoux    214-645-6605    Kirstie.LeDoux@UTSouthwestern.edu   
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Anje'l Thompson    713-500-7585    anjel.thompson@uth.tmc.edu   
Contact: Christa Miles    713-500-7585    christa.miles@uth.tmc.edu   
Metroplex Pulmonary and Sleep Recruiting
McKinney, Texas, United States, 75069
Contact: Ambreen Ahmed,, MBBS    972-838-1892    aahmed@mpsleepcenter.com   
United States, Utah
University of Utah Health Sciences Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Cassie Larsen    801-581-5811    cassie.larson@hsc.utah.edu   
United States, Virginia
Inova Heart and Vascular Institute Advanced Lung Disease Clinic Recruiting
Falls Church, Virginia, United States, 22042
Contact: Priscila Dauphin    703-776-7128    priscila.dauphin@inova.org   
Pulmonary Associates of Richmond Recruiting
Richmond, Virginia, United States, 23229
Contact: Betsy Daniel    804-396-4421    bdaniel@paraccess.com   
United States, Washington
University of Washington Medical Center Active, not recruiting
Seattle, Washington, United States, 981195
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Marion Santos    64-875-5091      
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, K7L 2V6
Contact: Leila Macbean    519-685-8500      
Sponsors and Collaborators
Bellerophon Pulse Technologies
Investigators
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Study Director: Edward Parsley, DO Bellerophon Therapeutics
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bellerophon Pulse Technologies
ClinicalTrials.gov Identifier: NCT03267108    
Other Study ID Numbers: PULSE-PHPF-001
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Bellerophon ( Bellerophon Pulse Technologies ):
Pulmonary Fibrosis
PF
Pulmonary Hypertension
Inhaled Nitric Oxide
iNO
Long Term Oxygen Therapy
Oxygen
REBUILD
INOpulse
pulsed inhaled nitric oxide
fILD
fibrotic interstitial lung disease
portable pulsed inhaled nitric oxide
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Fibrosis
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases