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Vasodilator
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (REBUILD Trial)
Phase 3
Waitlist Available
Research Sponsored by Bellerophon Pulse Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 4
Awards & highlights
Pivotal Trial
Summary
This trial tests if breathing in short bursts of nitric oxide gas can help patients with lung disease who are at risk for high blood pressure in their lungs and are already on oxygen therapy. The gas works by opening up blood vessels in the lungs to reduce pressure. Inhaled nitric oxide has been used to treat various heart and lung conditions by improving breathing and reducing pressure in the lungs.
Eligible Conditions
- Pulmonary Hypertension
- Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
Secondary study objectives
Change in 6 Minute Walk Distance
Change in Overall Activity as Measured by Actigraphy
Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Open Label ExtensionExperimental Treatment1 Intervention
Pulsed inhaled iNO 45 mcg/kg IBW/hr
Group II: Inhaled Nitric Oxide (iNO)Active Control1 Intervention
Pulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Group III: PlaceboPlacebo Group1 Intervention
Pulsed inhaled N2, 99.999% gas
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Who is running the clinical trial?
Bellerophon Pulse TechnologiesLead Sponsor
6 Previous Clinical Trials
659 Total Patients Enrolled
Edward Parsley, DOStudy DirectorBellerophon Therapeutics
2 Previous Clinical Trials
208 Total Patients Enrolled
Dominique DuchesneStudy DirectorHead Clinical Operations
Ashika AhmedStudy DirectorBellerophon Therapeutics
2 Previous Clinical Trials
30 Total Patients Enrolled