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

Phase 2

• Conditions: Pulmonary Hypertension; Pulmonary Fibrosis

• Registration Number: NCT05747508
• Lead Sponsor: Bellerophon

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)

Study Timeline

• Study Start: 2017-12-29
• Primary Completion: 2019-11-22
• Study First Submitted: 2021-07-27
• Status Verified: 2022-03
• Study First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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
    • 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)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.	Change from baseline to week 8 or 16	Part 1 - Blinded Treatment Period

Trial Locations

Locations (23)

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

Scroll for more (13 remaining)