Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease

NCT01372462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-10-12

Study results available
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Summary

Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD.

Conditions

Interventions

DEVICE

NIOV - Room Air

Noninvasive ventilation with device powered by compressed room air.

DEVICE

NIOV - Oxygen

Noninvasive ventilation with device powered by compressed medical (100%) oxygen.

DEVICE

Nasal Cannula Oxygen

Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.

Sponsors & Collaborators

  • Breathe Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Casaburi, Ph.D., M.D. · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

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 NCT01372462 on ClinicalTrials.gov