drugset
drugset / Trial / NCT01728220

Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD

NCT01728220 ↗

Phase 2 Completed 159 enrolled Bellerophon Pulse Technologies
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination product, inhaled nitric oxide/INOpulse DS-C vs. placebo in subjects with World Health Organization (WHO) Group 3 pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).

Timeline

Start
2012-12
Primary completion
2014-06
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 0.003 mg/kg Inhaled
Subject Nitric Oxide Other / unclassified 0.01 mg/kg Inhaled
Subject Nitric Oxide Other / unclassified 0.015 mg/kg Inhaled
Subject Nitric Oxide Other / unclassified 0.03 mg/kg Inhaled
Subject Nitric Oxide Other / unclassified 0.075 mg/kg Inhaled

Indications

chronic obstructive pulmonary disease pulmonary hypertension