drugset / Trial / NCT03135860

Effect iNO on Functional Respiratory Imaging in Subjects With WHO Group 3 Pulmonary Hypertension With COPD on Oxygen

NCT03135860

Phase 0 Terminated 7 enrolled Bellerophon
NaSingle-groupOpen-labelTreatment

Summary

The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of long term iNO administrationusing the device INOpulse for 4 weeks in relation to Patient Reported Outcome (PRO) and exercise tolerance in subjects with WHO Group 3 PH associated with COPD on LTOT. Changes from baseline to 4 weeks of pulsed iNO and after 2 weeks of withdrawal from pulsed iNO will be evaluated.

Timeline

Start
2016-10
Primary completion
2017-08-21
Completion
2017-08-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 30 ug/kg Inhaled