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A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
Study Purpose
A randomized, double-blind, placebo-controlled dose escalation and verification study to
assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) versus placebo in
subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term
oxygen therapy. (REBUILD)
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 80 Years
Gender
All
More Inclusion & Exclusion 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
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.
- Have been using oxygen therapy by nasal cannula for at least 4 weeks.
- 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 last 6 months prior to screening the
screening run-in period.
- Age between 18 and 80 years (inclusive)
Exclusion criteria:
- 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.
- A definitive diagnosis of a connective tissue disease (eg, systemic sclerosis, Lupus,
Sjögren's, mixed CTD or other CTD's via ACR/EULAR classification criteria)
- 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.
- Known permanent atrial fibrillation.
- 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 Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2/Phase 3
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Bellerophon Pulse Technologies
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Edward Parsley, DO
Principal Investigator Affiliation
Bellerophon Therapeutics
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Fibrosis, Pulmonary Hypertension
Additional Details
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) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary
fibrosis on long term oxygen therapy (REBUILD)
Arms & Interventions
Arms
Active Comparator: Inhaled Nitric Oxide (iNO)
Pulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Placebo Comparator: Placebo
Pulsed inhaled N2, 99.999% gas
Other: Open Label Extension
Pulsed inhaled iNO 45 mcg/kg IBW/hr
Interventions
Combination Product: - INOpulse
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Combination Product: - Placebo
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Combination Product: - Open Label Extension
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
