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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03267108
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )

Study Description
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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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 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 : July 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Bellerophon Pulse Technologies
Investigators
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Study Director: Ashika Ahmed Bellerophon Therapeutics
More Information
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Additional Information:

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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: February 21, 2023
Last Verified: January 2023
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
Lung Diseases, Interstitial