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Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.

NCT01265888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-09-19

No results posted yet for this study

Summary

A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo.

Conditions

Interventions

DRUG

Inhaled Nitric Oxide

Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM

DRUG

Inhaled Nitric Oxide

Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 2 LPM

DRUG

Inhaled Nitric Oxide

Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 4 LPM

Sponsors & Collaborators

  • Geno LLC

    lead INDUSTRY

Principal Investigators

  • Gregory Suplick · Geno LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2016-09-30
Completion
2016-09-30

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 NCT01265888 on ClinicalTrials.gov