A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.
A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
Part 1 - Blinded Treatment Period
Time frame: Change from baseline to week 8 or 16
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