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Pulmonary FibrosisPhase 3REBUILDNCT03267108

A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

A Phase 3 study testing INOpulse® and Open Label Extension in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Bellerophon Pulse Technologies at 64 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pulmonary Fibrosis, Pulmonary Hypertension
What is being tested?
INOpulse® and Open Label Extension
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
145 participants
Where
64 sitesin 2 countries
Study dates
14 Dec 2020to 30 Jun 2023
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using guidelines, as per American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
  • Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following:
  • Idiopathic pulmonary fibrosis
  • Idiopathic nonspecific interstitial pneumonia
  • Respiratory bronchiolitis-interstitial lung disease
  • Desquamative interstitial pneumonia
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  • 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
  • Connective Tissue Disease associated with IPF (CTD-ILD)
  • Interstitial Pneumonia with Autoimmune Features (IPAF)
  • Have been using oxygen therapy by nasal cannula for at least 4 weeks (including use limited to exertion)
  • 6MWD ≥ 100 meters and ≤ 400 meters at screening and Baseline/Randomization visits.
  • World Health Organization (WHO) Functional Class II-IV
  • Forced Vital Capacity ≥ 40% predicted within the 60 day Screening period
  • Age between 18 and 80 years (inclusive) at screening

Who cannot join

  • For women of child-bearing potential: Pregnant or breastfeeding females at Screening, or planning to get pregnant, or unwilling to use appropriate contraception if sexually active to avoid pregnancy during the study and for at least 30 days after discontinuation of the study drug.
  • Heart failure with reduced ejection fraction (HFrEF; systolic heart failure) with an ejection fraction of < 40%; or severe HF with preserved EF (HFpEF; diastolic HF)
  • History of sarcoidosis
  • History of chronic thrombo-embolic pulmonary hypertension (CTEPH; WHO group 4 PH)
  • Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study
  • Body mass index (BMI) >40 kg/m2 at screening
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  • Intermittent uncontrolled atrial fibrillation, in the opinion of the Principal Investigator
  • Known severe hepatic impairment, in the opinion of the Principal Investigator
  • Known severe renal impairment (Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) 2009 equation [Levy 2009] calculated creatinine clearance <30 ml/min) at screening

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

United States61 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • UC Denver Anschutz Medical Center

    Aurora, Colorado, 80046

  • Piedmont Healthcare

    Austell, Georgia, 30106

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

  • University of Alabama

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • The University of North Carolina at Chapel Hill Marsico Clinical Research Center

    Chapel Hill, North Carolina, 27517

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • Northwestern

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • St. Francis Sleep Allergy and Lung Institute

    Clearwater, Florida, 33765

  • University Hospitals

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish

    Denver, Colorado, 80206

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • North Shore University Hospital

    Evanston, Illinois, 60201

  • Inova Heart and Vascular Institute Advanced Lung Disease Clinic

    Falls Church, Virginia, 22042

  • University of California San Francisco

    Fresno, California, 93701

  • Pulmonix, LLC/LeBauer Cone Health

    Greensboro, North Carolina, 27403

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Ascension St. Vincent Hospital

    Indianapolis, Indiana, 46260

  • University of California

    Los Angeles, California, 90024

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202

  • University of Louisville

    Louisville, Kentucky, 40202

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470

  • Loyola University

    Maywood, Illinois, 60153

  • Metroplex Pulmonary and Sleep

    McKinney, Texas, 75069

  • University of Miami

    Miami, Florida, 33125

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • NYU Langone

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Amicis Research

    Northridge, California, 91324

  • Creighton University

    Omaha, Nebraska, 68124

  • Paloma Medical Group

    Paloma, California, 92675

  • Avanza Medical Research Center

    Pensacola, Florida, 32503

  • Thomas Jefferson University Korman Respiratory Institute

    Philadelphia, Pennsylvania, 19017

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Banner - University Medical Center Arizona

    Phoenix, Arizona, 85006

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona, 85012

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15123

  • The Oregon Clinic

    Portland, Oregon, 97220

  • 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

  • Southern Illinois University

    Springfield, Illinois, 62702 / 62794

  • Stanford University Medical Center

    Stanford, California, 94305

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Atlantic Health Respiratory Institute

    Summit, New Jersey, 07901

  • University of South Florida

    Tampa, Florida, 33612

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Cleveland Clinic

    Weston, Florida, 33331

Other trials in United States

Canada3 sites

  • Queen's University/Hotel Dieu Hospital

    Kingston, Ontario, K7L 5G2

  • London Health Sciences Centre

    London, Ontario, K7L 2V6

  • University of British Columbia

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Escalation and Verification Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) - REBUILD

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

Read the detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

Being tested
INOpulse®, Placebo, Open Label Extension
Keywords
Pulmonary Fibrosis, PF, Pulmonary Hypertension, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, Oxygen, REBUILD, INOpulse, pulsed inhaled nitric oxide, fILD, fibrotic interstitial lung disease, portable pulsed inhaled nitric oxide
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

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

  • PlaceboCombination product

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

  • Open Label ExtensionCombination product

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

Study groups in NCT03267108
Study groupRoleWhat they receive
Inhaled Nitric Oxide (iNO)Active comparatorPulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Receives: Combination Product: INOpulse®
PlaceboPlacebo comparatorPulsed inhaled N2, 99.999% gas
Receives: Combination Product: Placebo
Open Label ExtensionOtherPulsed inhaled iNO 45 mcg/kg IBW/hr
Receives: Combination Product: Open Label Extension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy

    Part 1 - Blinded Treatment Period

    Measured: Baseline to Month 4

  2. Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy

    Part 2 - Open Label Extension (OLE)

    Measured: Baseline to Month 4

Secondary outcomes (7)

  1. Change in Overall Activity as Measured by Actigraphy

    Part 1 - Blinded Treatment Period

    Measured: Baseline to M4

  2. Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)

    Part 1 Blinded Treatment Period: The UCSD SOBQ 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).

    Measured: Baseline to Month 4

  3. Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total

    Part 1 Blinded Treatment Period: SGRQ 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)

    Measured: Baseline to Month 4

  4. Time to Clinical Worsening

    Part 1 - Blinded Treatment Period

    Measured: Baseline to Month 4

  5. Time to Clinical Deterioration

    Part 1 Blinded Treatment Period

    Measured: Baseline to Month 4

  6. Time to Clinical Improvement

    Part 1 Blinded Treatment Period

    Measured: Baseline to Month 4

  7. Change in 6 Minute Walk Distance

    Part 1 Blinded Treatment Period

    Measured: Baseline to Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start14 Dec 2020
  3. Primary completion9 Jun 2023
  4. Study completion30 Jun 2023

Why it stopped: The trial did not meet its primary endpoint, hence was terminated due to futility.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03267108
Sponsor's protocol ID
PULSE-PHPF-001
Acronym
REBUILD
Status last verified
Jul 2023
First submitted
27 Aug 2017
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Nathan SD, Rajicic N, Dudenhofer R, Hussain R, Argula R, Bandyopadhyay D, Luckhardt T, Muehlemann N, Flaherty KR, Glassberg MK, Lancaster L, Raghu G, Fernandes P. Inhaled Nitric Oxide in Fibrotic Lung Disease: A Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2024 Dec;21(12):1661-1669. doi: 10.1513/AnnalsATS.202406-662OC.

    PubMed 39141673

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INOpulse® and Open Label Extension in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Bellerophon Pulse Technologies at 64 sites in 2 countries.

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 21 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial did not meet its primary endpoint, hence was terminated due to futility.). 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?

Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy (time frame: Baseline to Month 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03267108, which also lists 1 linked publication.

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 27 Jul 2023.

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