drugset / Trial / NCT02267655
3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |