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

Phase 3

Terminated

• Conditions: Pulmonary Hypertension; Pulmonary Fibrosis

• Registration Number: NCT03267108
• Lead Sponsor: Bellerophon Pulse Technologies

Brief 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

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

Study Timeline

• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-08-27
• Study First Posted: 2017-08-30
• Study Start: 2020-12-14
• Primary Completion: 2023-06-09
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy	Baseline to Month 4	Part 1 - Blinded Treatment Period
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy	Baseline to Month 4	Part 2 - Open Label Extension (OLE)

Secondary Outcome Measures

Name	Time	Method
Time to Clinical Improvement	Baseline to Month 4	Part 1 Blinded Treatment Period
Time to Clinical Worsening	Baseline to Month 4	Part 1 - Blinded Treatment Period
Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total	Baseline to Month 4	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)
Time to Clinical Deterioration	Baseline to Month 4	Part 1 Blinded Treatment Period
Change in Overall Activity as Measured by Actigraphy	Baseline to M4	Part 1 - Blinded Treatment Period
Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)	Baseline to Month 4	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).
Change in 6 Minute Walk Distance	Baseline to Month 4	Part 1 Blinded Treatment Period

Trial Locations

Locations (64)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Banner - University Medical Center Arizona; 🇺🇸 Phoenix, Arizona, United States

Arizona Pulmonary Specialists, Ltd.; 🇺🇸 Phoenix, Arizona, United States

University of California San Francisco; 🇺🇸 Fresno, California, United States

University of California; 🇺🇸 Los Angeles, California, United States

Amicis Research; 🇺🇸 Northridge, California, United States

Paloma Medical Group; 🇺🇸 Paloma, California, United States

University of California Davis Health; 🇺🇸 Sacramento, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

UC Denver Anschutz Medical Center; 🇺🇸 Aurora, Colorado, United States

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