A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Fibrosis, Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT05747508

Run by

Bellerophon

People needed

85

Starts

2017-12-29

Expected to finish

2023-12-01

Last updated by the study team

2023-02-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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
• 6-Minute Walk Distance (6MWD) ≥ 100 meters and ≤ 450 meters at screening and Baseline/Randomization visits
• World Health Organization (WHO) Functional Class II-IV
• Forced Vital Capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period
• Age between 18 and 85 years (inclusive)

You may not qualify if…

• 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

Where it is running

• Arizona Pulmonary Specialists — Phoenix, Arizona, United States
• University of California — Los Angeles, California, United States
• University of California Davis Health — Sacramento, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• University of Miami — Miami, Florida, United States
• Avanza Medical Research Center — Pensacola, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Piedmont Healthcare Pulmonary & Critical Care Research — Austell, Georgia, United States
• Loyola University — Chicago, Illinois, United States
• Norton Pulmonary Specialists — Louisville, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• The Lung Research Center (St. Luke's) — Chesterfield, Missouri, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• Thomas Jefferson University Korman Respiratory Institute — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah Health Sciences — Salt Lake City, Utah, United States
• Inova Heart and Vascular Institute Advanced Lung Disease Clinic — Falls Church, Virginia, United States
• Pulmonary Associates of Richmond — Richmond, Virginia, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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