drugset / Trial / NCT00626028

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

NCT00626028 ↗

Phase 3 Completed 136 enrolled Mallinckrodt
RandomizedCrossoverOpen-labelDiagnostic

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.

Timeline

Start
2004-09
Primary completion
2010-02
Completion
2010-02

Outcome

Mixed primary results

paper more acute responders were identified with the iNO/O(2) combination vs. O(2) alone. PMID 20405117 ↗

paper 26% vs. 14%, P = 0.019 PMID 20405117 ↗

paper While there was no significant difference in acute responder rate with iNO alone vs. iNO/O(2) PMID 20405117 ↗

paper 27% vs. 24%, P = 0.602 PMID 20405117 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 80 ppm Inhaled
Subject Oxygen Other / unclassified 100 % Inhaled