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

Not Applicable

Completed

Interventions: Device: NIOV - Room Air
Device: NIOV - Oxygen
Device: Nasal Cannula Oxygen

Brief 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.

Detailed Description: Study was a randomized double-blinded crossover design in which subjects completed a series of exercises at a constant work rate while using 1) Test noninvasive ventilation (NIOV) system powered by compressed air, 2) Test NIOV system powered by 100% oxygen, 3) nasal cannula oxygen, 4) nothing (Control). Subjects were assessed during constant work rate exercise as reflected by exercise duration, isotime oxygenation (SpO2), and isotime dyspnea score (Borg). Exercise sessions took place over 4 visits with each visit lasting approximately 5 hours.

Recruitment & Eligibility

Inclusion Criteria

Adult males, ≥ 40 years of age
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 acute exacerbation of COPD within 30 days of screening
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

Arm && Interventions

Group	Intervention	Description
NIOV - Room air	NIOV - Room Air	Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Oxygen	NIOV - Oxygen	Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
Nasal Cannula Oxygen	Nasal Cannula Oxygen	Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).

Primary Outcome Measures

Name	Time	Method
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions	Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.	Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).

Secondary Outcome Measures

Name	Time	Method
Borg Dyspnea Score During Constant Workrate Exercise at Isotime	Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N	Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome. 0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome
SpO2 During Constant Workrate Exercise at Isotime	Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg	Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).