Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
NCT ID: NCT01372462
Last Updated: 2016-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2011-07-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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NIOV - Room air
Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air
Noninvasive ventilation with device powered by compressed room air.
NIOV - Oxygen
Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen
Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
Nasal Cannula Oxygen
Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen
Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
No treatment
Control arm. Subjects exercise without using supplemental oxygen or NIOV.
No interventions assigned to this group
Interventions
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NIOV - Room Air
Noninvasive ventilation with device powered by compressed room air.
NIOV - Oxygen
Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
Nasal Cannula Oxygen
Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 \< 50% of predicted and an FEV1/FVC ratio \< 70% of predicted
* Ventilatory limitation to exercise, documented by a VE/MVV \> 0.85
* SpO2 between 80% and 88% during incremental exercise testing on room air
* Willingness and ability (after training) to exercise on a cycle ergometer
* Willingness and ability to perform all other study related procedures and tasks
* Ability to be properly fitted with the Breathe nasal mask
* Ability to tolerate and be appropriately titrated on the Breathe ventilator (See Appendix E)
* Ability to be properly fitted with an exercise mask
* Fluency in written and spoken English
* Provision of written informed consent
Exclusion Criteria
* History of serious epistaxis within 14 days of screening
* Requirement of \> 5 LPM nasal O2 to maintain an SpO2 \> 90% while at rest
* History of pneumothorax secondary to lung bullae
* History of intolerance to supplemental oxygen
* Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
* Inability to achieve an optimal CWR level (4-7 minutes) during Study Visit 1R
* Current participation in another interventional study or participation within 14 days of screening
* Presence of any condition or abnormality that in the opinion of the Principal Investigator may compromise the subject's safety or the quality of the study data
40 Years
MALE
Yes
Sponsors
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Breathe Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Casaburi, Ph.D., M.D.
Role: PRINCIPAL_INVESTIGATOR
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Locations
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Harbor-UCLA Medical Center
Torrance, California, United States
Countries
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Other Identifiers
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CP-00-0035
Identifier Type: -
Identifier Source: org_study_id
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