NCT00626028

Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 4 Weeks – 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

Conditions

• Idiopathic Pulmonary Arterial Hypertension
• Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Nitric Oxide for inhalation	Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
DRUG	Oxygen	100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
DRUG	Nitric Oxide plus Oxygen	Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-02-29
• Last updated: 2019-12-20
• Results posted: 2010-09-16

Locations

18 sites across 5 countries: United States, France, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study