drugset / Trial / NCT02267655

3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF

NCT02267655

Phase 1 Completed 8 enrolled Bellerophon
RandomizedParallel-groupTriple-blindTreatment

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 short term a) iNO administration and b) nitric oxide (NO) cylinder concentration using the investigational medical device INOpulse® DS-C in subjects with WHO Group 3 PH associated with COPD on LTOT (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)

Timeline

Start
2015-05
Primary completion
2017-06
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitric Oxide Other / unclassified 5 ug/kg Inhaled
Comparator Nitric Oxide Other / unclassified 10 ug/kg Inhaled
Comparator Nitric Oxide Other / unclassified 15 ug/kg Inhaled
Comparator Nitric Oxide Other / unclassified 30 ug/kg Inhaled
Comparator Nitric Oxide Other / unclassified 75 ug/kg Inhaled