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

  • STATUS
    Recruiting
  • End date
    Dec 17, 2023
  • participants needed
    300
  • sponsor
    Bellerophon Pulse Technologies
Updated on 17 November 2021
ct scan
pneumonia
dyspnea
vasodilator
pulmonary disease
nitric oxide
pulmonary fibrosis
arginine
fibrosis
emphysema
rheumatism
progressive systemic sclerosis
idiopathic pulmonary fibrosis
pulmonary arterial hypertension
right heart catheterization
endothelin
pulmonary arterial pressure
systemic sclerosis
forced vital capacity
interstitial lung disease
endothelin receptor antagonist
prostacyclin
left ventricular end-diastolic pressure
epoprostenol

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

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

Details
Condition Pulmonary Disease, Pulmonary Hypertension, Pulmonary Fibrosis, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Lung Disease, Memory Problems, lung fibrosis
Treatment Placebo, Inhaled Nitric Oxide, iNO, INOpulse, Open Label Extension, INOpulse®
Clinical Study IdentifierNCT03267108
SponsorBellerophon Pulse Technologies
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

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
Unclassifiable idiopathic interstitial pneumonias
Chronic hypersensitivity pneumonitis
Idiopathic pleuroparenchymal fibroelastosis
Occupational lung disease
Connective Tissue Disease associated with IPF (CTD-ILD)
Interstitial Pneumonia with Autoimmune Features (IPAF)
MWD 100 meters and 400 meters at screening and Baseline/Randomization visits
Have been using oxygen therapy by nasal cannula for at least 4 weeks (including use limited to exertion)
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
Known severe hepatic impairment, in the opinion of the Principal Investigator
Intermittent uncontrolled atrial fibrillation, 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
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