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

NCT01728220 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-02-27

No results posted yet for this study

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).

Conditions

Interventions

COMBINATION_PRODUCT

Inhaled NO delivered via INOpulse DS-C Device

Subjects will be treated with nitric oxide by means of an INOpulse DS-C device using an INOpulse nasal cannula.

COMBINATION_PRODUCT

Placebo delivered via INOpulse DS-C Device

Subjects will be treated with nitrogen gas by means of an INOpulse DS-C device using an INOpulse nasal cannula.

Sponsors & Collaborators

  • Bellerophon Pulse Technologies

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed, MD · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • United States

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 NCT01728220 on ClinicalTrials.gov