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

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ClinicalTrials.gov Identifier: NCT03267108
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : May 6, 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) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. (REBUILD)

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Pulmonary Hypertension Combination Product: INOpulse Combination Product: Placebo Combination Product: Open Label Extension Phase 2 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) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (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 (REBUILD)
Actual Study Start Date : December 29, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : October 2022

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:

  • 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

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
Show Show 38 study locations
Sponsors and Collaborators
Bellerophon Pulse Technologies
Investigators
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Study Director: Edward Parsley, DO Bellerophon Therapeutics
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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: May 6, 2021
Last Verified: May 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: No
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