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

Primary Purpose

Pulmonary Fibrosis, Pulmonary Hypertension

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INOpulse®
Placebo
Long Term Follow Up
Sponsored by
Bellerophon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Pulmonary Fibrosis (PF), Pulmonary Hypertension, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, Oxygen

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Pulmonary Specialists
  • University of California
  • University of California Davis Health
  • University of Colorado Hospital
  • University of Miami
  • Avanza Medical Research Center
  • Emory University
  • Piedmont Healthcare Pulmonary & Critical Care Research
  • Loyola University
  • Norton Pulmonary Specialists
  • University of Michigan
  • The Lung Research Center (St. Luke's)
  • The University of North Carolina at Chapel Hill
  • University of Cincinnati College of Medicine
  • Thomas Jefferson University Korman Respiratory Institute
  • Temple University Hospital
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • University of Texas Southwestern Medical Center
  • University of Utah Health Sciences
  • Inova Heart and Vascular Institute Advanced Lung Disease Clinic
  • Pulmonary Associates of Richmond
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Inhaled Nitric Oxide (iNO)

Placebo

Long Term Follow Up

Arm Description

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

Pulsed inhaled N2, 99.999% gas

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2021
Last Updated
February 17, 2023
Sponsor
Bellerophon
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1. Study Identification

Unique Protocol Identification Number
NCT05747508
Brief Title
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2017 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellerophon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Pulmonary Hypertension
Keywords
Pulmonary Fibrosis (PF), Pulmonary Hypertension, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide (iNO)
Arm Type
Active Comparator
Arm Description
Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pulsed inhaled N2, 99.999% gas
Arm Title
Long Term Follow Up
Arm Type
Active Comparator
Arm Description
Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr
Intervention Type
Combination Product
Intervention Name(s)
INOpulse®
Intervention Description
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Intervention Type
Combination Product
Intervention Name(s)
Long Term Follow Up
Intervention Description
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Primary Outcome Measure Information:
Title
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
Description
Part 1 - Blinded Treatment Period
Time Frame
Change from baseline to week 8 or 16
Other Pre-specified Outcome Measures:
Title
Change in 6-minute walking test (6MWT) from baseline
Description
Part 1 - Blinded Treatment Period
Time Frame
Change from baseline to week 8 or 16
Title
Difference in activity as measured using ActiGraph devices
Description
Part 1 - Blinded Treatment Period
Time Frame
Change from baseline to week 8 or 16
Title
Percentage of patients with ≥15% decrease in activity
Description
Part 1 - Blinded Treatment Period
Time Frame
Change from baseline to to week 8 or 16
Title
Difference in dyspnea as measured by University of California San Diego Shortness of Breath Questionnaire
Description
The University of California San Diego Shortness of Breath Questionnaire is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
Time Frame
Change from baseline to to week 8 or 16
Title
Difference in St. George Respiratory Questionnaire and sub-groups
Description
St. George Respiratory Questionnaire and sub-groups is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)
Time Frame
Change from baseline to to week 8 or 16
Title
Percentage of patients with a clinically meaningful difference (reduction of at least 4 points) in the disease-specific quality of life measured using the disease specific St. George Respiratory Questionnaire (SGRQ)
Description
Part 1 - Blinded Treatment Period
Time Frame
Change from baseline to to week 8 or 16
Title
Change in N-terminal (NT)-ProBNP (absolute and percentage)
Description
Part 1 - Blinded Treatment Period
Time Frame
Change from baseline to week 8 or 16
Title
Time to clinical improvement
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Time to clinical worsening
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Incidence and severity of treatment emergent adverse events, including those related to INOpulse® device deficiency
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Adverse events that may be due to rebound associated with a temporal acute withdrawal of investigational study drug
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Change in diffusing capacity of the lungs for carbon monoxide (DLCO)
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Mortality
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Hospitalization (all cause and for cardiopulmonary or other cause)
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Change in Forced Expiratory Volume at 1 minute (FEV1)
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16
Title
Change in Forced Vital Capacity (FVC)
Description
Part 1 - Blinded Treatment Period
Time Frame
Baseline to week 8 or 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashika Ahmed, MD
Organizational Affiliation
Bellerophon Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Pulmonary Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Piedmont Healthcare Pulmonary & Critical Care Research
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Loyola University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Norton Pulmonary Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1332
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
The Lung Research Center (St. Luke's)
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Thomas Jefferson University Korman Respiratory Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19017
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Utah Health Sciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Heart and Vascular Institute Advanced Lung Disease Clinic
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Pulmonary Associates of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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