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

NCT05747508 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: PULSE-PHPF-001 Phase 2
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 23

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.

Conditions

Pulmonary Fibrosis; Pulmonary Hypertension

Keywords

Pulmonary Fibrosis (PF); Pulmonary Hypertension; Inhaled Nitric Oxide; iNO; Long Term Oxygen Therapy; Oxygen

Outcome Measures

Primary Outcomes (1)

• Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.

  Part 1 - Blinded Treatment Period

  Change from baseline to week 8 or 16

Other Outcomes (16)

• Change in 6-minute walking test (6MWT) from baseline

  Change from baseline to week 8 or 16

• Difference in activity as measured using ActiGraph devices

  Change from baseline to week 8 or 16

• Percentage of patients with ≥15% decrease in activity

  Change from baseline to to week 8 or 16

Study Arms (3)

Inhaled Nitric Oxide (iNO)

ACTIVE COMPARATOR

Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr)

Combination Product: INOpulse®

Placebo

PLACEBO COMPARATOR

Pulsed inhaled N2, 99.999% gas

Combination Product: Placebo

Long Term Follow Up

ACTIVE COMPARATOR

Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr

Combination Product: Long Term Follow Up

Interventions

INOpulse® COMBINATION_PRODUCT

Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula

Inhaled Nitric Oxide (iNO)

Placebo COMBINATION_PRODUCT

Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula

Placebo

Long Term Follow Up COMBINATION_PRODUCT

Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula

Long Term Follow Up

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Bellerophon: lead

Study Sites (23)

Arizona Pulmonary Specialists

Phoenix, Arizona, 85012, United States

Location

University of California

Los Angeles, California, 90024, United States

Location

University of California Davis Health

Sacramento, California, 95817, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Piedmont Healthcare Pulmonary & Critical Care Research

Austell, Georgia, 30106, United States

Location

Loyola University

Chicago, Illinois, 60153, United States

Location

Norton Pulmonary Specialists

Louisville, Kentucky, 40202-1332, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

The Lung Research Center (St. Luke's)

Chesterfield, Missouri, 63017, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Thomas Jefferson University Korman Respiratory Institute

Philadelphia, Pennsylvania, 19017, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah Health Sciences

Salt Lake City, Utah, 84108, United States

Location

Inova Heart and Vascular Institute Advanced Lung Disease Clinic

Falls Church, Virginia, 22042, United States

Location

Pulmonary Associates of Richmond

Richmond, Virginia, 23229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ashika Ahmed, MD

  Bellerophon Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: February 28, 2023
• Study Start: December 29, 2017
• Primary Completion: November 22, 2019
• Study Completion: December 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)