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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of the Physiologic Effects of Using the Breathe Technologies Noninvasive Open Ventilation System During Constant Work Rate Exercise in Subjects With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: NIOV - Room Air
* Device: NIOV - Oxygen
* Device: Nasal Cannula Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIOV - Room air<br>Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2). | Device: NIOV - Room Air<br>* Noninvasive ventilation with device powered by compressed room air.<br>* Other names: NIOV;|
| Experimental: NIOV - Oxygen<br>Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2). | Device: NIOV - Oxygen<br>* Noninvasive ventilation with device powered by compressed medical (100%) oxygen.<br>* Other names: NIOV;|
| Active Comparator: Nasal Cannula Oxygen<br>Subjects exercise using a standard nasal cannula using medical oxygen (100% O2). | Device: Nasal Cannula Oxygen<br>* Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.<br>* Other names: Cannula;|
| No Intervention: No treatment<br>Control arm. Subjects exercise without using supplemental oxygen or NIOV. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions | Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control). | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 During Constant Workrate Exercise at Isotime | Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control). | 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 | 
| Borg Dyspnea Score During Constant Workrate Exercise at Isotime | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Ventilator, Constant work rate