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
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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