A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2)

Bellerophon23 sites in 1 country85 target enrollmentDecember 29, 2017

ConditionsPulmonary Fibrosis Pulmonary Hypertension

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pulmonary Fibrosis
Sponsor: Bellerophon
Enrollment: 85
Locations: 23
Primary Endpoint: Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.

Detailed Description

A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2)

Registry

clinicaltrials.gov

Start Date

December 29, 2017

End Date

December 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bellerophon

Responsible Party

Sponsor

Eligibility 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 one of the following guidelines, as per American Thoracic Society (AGS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
•Major idiopathic interstitial pneumonias (IIPs) 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

Exclusion Criteria

•Pregnant or breastfeeding females at Screening
•In the last 6 months prior to screening, evidence of any connective tissue disease with FVC \> 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the local radiologist/Investigator