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Status unknownNCT05747508Updated Feb 28, 2023

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

A Phase 2 interventional study of INOpulse® and Placebo in Pulmonary Fibrosis and Pulmonary Hypertension, sponsored by Bellerophon. Status unknown at 23 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Bellerophon · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Dec 2017, registered Jul 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Pulmonary Fibrosis
  • Pulmonary Hypertension

Keywords

  • Pulmonary Fibrosis (PF)
  • Pulmonary Hypertension
  • Inhaled Nitric Oxide
  • iNO
  • Long Term Oxygen Therapy
  • Oxygen
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 85 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Bellerophon is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
85 participants (actual)

Study arms

  • Active comparator
    Inhaled Nitric Oxide (iNO)

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

    Combination Product: INOpulse®

  • Placebo comparator
    Placebo

    Pulsed inhaled N2, 99.999% gas

    Combination Product: Placebo

  • Active comparator
    Long Term Follow Up

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

    Combination Product: Long Term Follow Up

Interventions

  • Combination productINOpulse®

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

  • Combination productPlacebo

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

  • Combination productLong Term Follow Up

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

06

What researchers measure

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

    Time frame: Change from baseline to week 8 or 16

Other outcomes

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

    Part 1 - Blinded Treatment Period

    Time frame: Change from baseline to week 8 or 16

  2. Difference in activity as measured using ActiGraph devices

    Part 1 - Blinded Treatment Period

    Time frame: Change from baseline to week 8 or 16

  3. Percentage of patients with ≥15% decrease in activity

    Part 1 - Blinded Treatment Period

    Time frame: Change from baseline to to week 8 or 16

  4. Difference in dyspnea as measured by University of California San Diego Shortness of Breath Questionnaire

    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

  5. Difference in St. George Respiratory Questionnaire and sub-groups

    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

  6. 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)

    Part 1 - Blinded Treatment Period

    Time frame: Change from baseline to to week 8 or 16

  7. Change in N-terminal (NT)-ProBNP (absolute and percentage)

    Part 1 - Blinded Treatment Period

    Time frame: Change from baseline to week 8 or 16

  8. Time to clinical improvement

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  9. Time to clinical worsening

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  10. Incidence and severity of treatment emergent adverse events, including those related to INOpulse® device deficiency

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  11. Adverse events that may be due to rebound associated with a temporal acute withdrawal of investigational study drug

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  12. Change in diffusing capacity of the lungs for carbon monoxide (DLCO)

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  13. Mortality

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  14. Hospitalization (all cause and for cardiopulmonary or other cause)

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  15. Change in Forced Expiratory Volume at 1 minute (FEV1)

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

  16. Change in Forced Vital Capacity (FVC)

    Part 1 - Blinded Treatment Period

    Time frame: Baseline to week 8 or 16

07

Study locations

23 sites
  • Arizona Pulmonary Specialists
    Phoenix, Arizona 85012, United States
  • University of California
    Los Angeles, California 90024, United States
  • University of California Davis Health
    Sacramento, California 95817, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • University of Miami
    Miami, Florida 33125, United States
  • Avanza Medical Research Center
    Pensacola, Florida 32503, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Piedmont Healthcare Pulmonary & Critical Care Research
    Austell, Georgia 30106, United States
  • Loyola University
    Chicago, Illinois 60153, United States
  • Norton Pulmonary Specialists
    Louisville, Kentucky 40202-1332, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • The Lung Research Center (St. Luke's)
    Chesterfield, Missouri 63017, United States
  • The University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27517, United States
  • University of Cincinnati College of Medicine
    Cincinnati, Ohio 45267, United States
  • Thomas Jefferson University Korman Respiratory Institute
    Philadelphia, Pennsylvania 19017, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • University of Utah Health Sciences
    Salt Lake City, Utah 84108, United States
  • Inova Heart and Vascular Institute Advanced Lung Disease Clinic
    Falls Church, Virginia 22042, United States
  • Pulmonary Associates of Richmond
    Richmond, Virginia 23229, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05747508
Lead sponsor
Bellerophon
Responsible party
Sponsor
First posted
Feb 28, 2023
Start date
Dec 29, 2017
Primary completion
Nov 22, 2019
Completion
Dec 2023 (estimated)
Last update
Feb 28, 2023

Study contacts

Ashika Ahmed, MD
study director · Bellerophon Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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