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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
Part 1 - Blinded Treatment Period
Time frame: Baseline to Month 4
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy
Part 2 - Open Label Extension (OLE)
Time frame: Baseline to Month 4
Change in Overall Activity as Measured by Actigraphy
Part 1 - Blinded Treatment Period
Time frame: Baseline to M4
Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
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).
Time frame: Baseline to Month 4
Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total
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 frame: Baseline to Month 4
Time to Clinical Worsening
Part 1 - Blinded Treatment Period
Time frame: Baseline to Month 4
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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
...and 54 more locations
Time to Clinical Deterioration
Part 1 Blinded Treatment Period
Time frame: Baseline to Month 4
Time to Clinical Improvement
Part 1 Blinded Treatment Period
Time frame: Baseline to Month 4
Change in 6 Minute Walk Distance
Part 1 Blinded Treatment Period
Time frame: Baseline to Month 4