A 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 of Pulmonary Hypertension associated with Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2)

Brief description of study

The purpose of this study is to determine if the study drug, inhaled nitric oxide (iNO), when given and breathed through an investigational study device, the INOpulse®, may help treat patients with fibrotic interstitial lung disease (fILD) on oxygen therapy and are at risk of having or developing pulmonary hypertension associated with pulmonary fibrosis (PH-PF).Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. Inhaled nitric oxide and the INOpulse® delivery system are investigational for the treatment of fILD in patients at risk of having or developing PH-PF and are not currently an approved treatment. “Investigational” means that the drug and device combination tested in this study has not been approved by the FDA or any other health authority.


Clinical Study Identifier: s20-01671
ClinicalTrials.gov Identifier: NCT03267108
Principal Investigator: Roxana Sulica.


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