Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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

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

Details

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

Keywords

Pulmonary Fibrosis Pulmonary Hypertension PF 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 Hypertension, Pulmonary Hypertension Fibrosis INOpulse® Open Label Extension Inhaled Nitric Oxide (iNO)

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join 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

Locations

  • University of California Davis Health accepting new patients
    Sacramento California 95817 United States
  • Stanford University Medical Center accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bellerophon Pulse Technologies
Links
Study website link Sign up for this study
ID
NCT03267108
Phase
Phase 3
Study Type
Interventional
Last Updated