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 (REBUILD)

  • End date
    Dec 15, 2023
  • participants needed
  • sponsor
    Bellerophon Pulse Technologies
Updated on 15 October 2022
ct scan
pulmonary disease
nitric oxide
pulmonary fibrosis
progressive systemic sclerosis
idiopathic pulmonary fibrosis
pulmonary arterial hypertension
right heart catheterization
pulmonary arterial pressure
systemic sclerosis
forced vital capacity
interstitial lung disease
endothelin receptor antagonist
left ventricular end-diastolic pressure


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


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

Condition Pulmonary Fibrosis, Pulmonary Hypertension
Treatment Placebo, Inhaled Nitric Oxide, iNO, INOpulse, Open Label Extension, INOpulse®
Clinical Study IdentifierNCT03267108
SponsorBellerophon Pulse Technologies
Last Modified on15 October 2022


Yes No Not Sure

Inclusion Criteria

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
Cryptogenic organizing pneumonia
Acute interstitial pneumonia
Rare IIPs diagnosis by one of the following
Unclassifiable idiopathic interstitial pneumonias
Idiopathic lymphoid interstitial pneumonia
Chronic hypersensitivity pneumonitis
Idiopathic pleuroparenchymal fibroelastosis
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
World Health Organization (WHO) Functional Class II-IV
limited to exertion)
MWD ≥ 100 meters and ≤ 400 meters at screening and Baseline/Randomization visits
Forced Vital Capacity ≥ 40% predicted within the 60 day Screening period
Age between 18 and 80 years (inclusive) at screening

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
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 severe hepatic impairment, in the opinion of the Principal Investigator
Intermittent uncontrolled atrial fibrillation, 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note