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Vasodilator

Open Label Extension 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

REBUILD Trial Summary

This trial is testing the safety and effectiveness of a drug called inhaled nitric oxide in people at risk for pulmonary hypertension associated with pulmonary fibrosis. The trial is divided into two parts.

Eligible Conditions
  • Pulmonary Hypertension
  • Pulmonary Fibrosis

REBUILD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
Secondary outcome measures
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 more

REBUILD 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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be a candidate for enrolling in this trial?

"Researchers conducting this clinical trial aim to enroll 300 patients that have pulmonary fibrosis and are between 18-80 years old. Additionally, these patients must have unclassifiable idiopathic interstitial pneumonias or cryptogenic organizing pneumonia."

Answered by AI

What is the continent-wide distribution of this research project?

"This trial is being conducted at 69 sites, which are located across the United States of America. Some of the notable enrolment locations include The Oregon Clinic in Portland, AnMed Health in Anderson, and University of Pennsylvania in Philadelphia."

Answered by AI

Does the medical literature on Inhaled Nitric Oxide (iNO) date back far?

"The University of Chicago first ran a clinical trial with inhaled nitric oxide (iNO) in 2008 and, since then, 18322 similar studies have been completed. There are 24 trials actively recruiting patients at the moment, the majority of which are based in Portland, Oregon."

Answered by AI

Does this research project allow senior citizens to participate?

"This study includes patients that are over 18 but younger than 80."

Answered by AI

Are there any risks associated with Inhaled Nitric Oxide (iNO)?

"There is existing clinical data that supports the efficacy of Inhaled Nitric Oxide (iNO), making it a safe option with a score of 3."

Answered by AI

Are enrolling any new patients at this time?

"The study is still recruiting patients, as seen on clinicaltrials.gov. The posting date was December 14th, 2020, and the most recent edit was on October 20th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Baylor University Medical Center
University of Texas Health Science Center at Houston

Why did patients apply to this trial?

I have not been treated yet, have CAD,GERD,Ejection Fraction Diffused <50. IPF hypertension.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

What chance of getting sick?
PatientReceived 2+ prior treatments
Recent research and studies
Annals of the American Thoracic SocietyJournal
A Phase-2 Exploratory Randomized Controlled Trial of Inopulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen
King, Christopher S., Kevin R. Flaherty, Marilyn K. Glassberg, Lisa Lancaster, Ganesh Raghu, Jeffrey J. Swigris, Rahul G. Argula, et al.. 2022. “A Phase-2 Exploratory Randomized Controlled Trial of Inopulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen”. Annals of the American Thoracic Society. American Thoracic Society. doi:10.1513/annalsats.202107-864oc.
clinicaltrials.govStudy
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
2020. "A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03267108.
~33 spots leftby Apr 2025
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