Pulmonary FibrosisPhase 2NCT05747508
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
A Phase 2 study testing INOpulse® and Long Term Follow Up in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Bellerophon at 23 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Fibrosis, Pulmonary Hypertension
- What is being tested?
- INOpulse® and Long Term Follow Up
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 23 sitesUnited States
- Study dates
- 29 Dec 2017to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Piedmont Healthcare Pulmonary & Critical Care Research
Austell, Georgia, 30106
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Medical University of South Carolina
Charleston, South Carolina, 29425
The Lung Research Center (St. Luke's)
Chesterfield, Missouri, 63017
Loyola University
Chicago, Illinois, 60153
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Inova Heart and Vascular Institute Advanced Lung Disease Clinic
Falls Church, Virginia, 22042
University of California
Los Angeles, California, 90024
Norton Pulmonary Specialists
Louisville, Kentucky, 40202-1332
University of Miami
Miami, Florida, 33125
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Avanza Medical Research Center
Pensacola, Florida, 32503
Thomas Jefferson University Korman Respiratory Institute
Philadelphia, Pennsylvania, 19017
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
Pulmonary Associates of Richmond
Richmond, Virginia, 23229
University of California Davis Health
Sacramento, California, 95817
University of Utah Health Sciences
Salt Lake City, Utah, 84108
University of Washington Medical Center
Seattle, Washington, 98195
About this study
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)
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)
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Being tested
- INOpulse®, Placebo, Long Term Follow Up
- Keywords
- Pulmonary Fibrosis (PF), Pulmonary Hypertension, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, Oxygen
- Medical subject headings
- Pulmonary Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOpulse®Combination product
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
PlaceboCombination product
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Long Term Follow UpCombination product
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide (iNO) | Active comparator | Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr) Receives: Combination Product: INOpulse® |
| Placebo | Placebo comparator | Pulsed inhaled N2, 99.999% gas Receives: Combination Product: Placebo |
| Long Term Follow Up | Active comparator | Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr Receives: Combination Product: Long Term Follow Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to week 8 or 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start29 Dec 2017
- Primary completion22 Nov 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellerophon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashika Ahmed, MD, Study director, Bellerophon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747508
- Sponsor's protocol ID
- PULSE-PHPF-001 Phase 2
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05747508
- Acronym / sponsor ID
- PULSE-PHPF-001 Phase 2
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Keywords
- Pulmonary Fibrosis (PF), Pulmonary Hypertension, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, Oxygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (actual)
- Lead sponsor
- BellerophonIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide (iNO) | Active comparator | Combination Product: INOpulse®Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr) |
| Placebo | Placebo comparator | Combination Product: PlaceboPulsed inhaled N2, 99.999% gas |
| Long Term Follow Up | Active comparator | Combination Product: Long Term Follow UpPulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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):
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INOpulse®Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula | Combination product | Inhaled Nitric Oxide (iNO) |
| PlaceboPatients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula | Combination product | Placebo |
| Long Term Follow UpPatients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula | Combination product | Long Term Follow Up |
Primary outcome
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
Time frame: Change from baseline to week 8 or 16
Part 1 - Blinded Treatment Period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Fibrosis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashika Ahmed, MD study director
Bellerophon Therapeutics
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INOpulse® and Long Term Follow Up in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Bellerophon at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity. (time frame: Change from baseline to week 8 or 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.