drugset / Trial / NCT02170519

Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

NCT02170519

Phase 4 Terminated 27 enrolled Duke University
Non-randomizedCrossoverOpen-labelTreatment

Summary

Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Timeline

Start
2006-09
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Iloprost Other / unclassified 5 ug Inhaled
Subject Iloprost Other / unclassified 20 ug Inhaled
Subject Iloprost Other / unclassified 30 ug Inhaled