MedTrace Logo

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

NCT02267655 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-02-21

No results posted yet for this study

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)

Conditions

Interventions

DRUG

inhaled Nitric Oxide - 30 mcg/kg IBW/hr

inhaled Nitric Oxide in 30 mcg/kg IBW/hr doses Part 1

DRUG

inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr

inhaled inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr dose titration

DRUG

inhaled nitric oxide 75 mcg/kg IBW/hr

inhaled nitric oxide 75 mcg/kg IBW/hr -Part 2b

Sponsors & Collaborators

  • Bellerophon

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-06-30
Completion
2017-06-28

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267655 on ClinicalTrials.gov