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

Breathe Technologies

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: NIOV - Room Air; Device: NIOV - Oxygen; Device: Nasal Cannula Oxygen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01372462

CP-00-0035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 4 patient groups

NIOV - Room air

Experimental group

Description:

Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).

Treatment:

Device: NIOV - Room Air

NIOV - Oxygen

Experimental group

Description:

Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).

Treatment:

Device: NIOV - Oxygen

Nasal Cannula Oxygen

Active Comparator group

Description:

Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).

Treatment:

Device: Nasal Cannula Oxygen

No treatment

No Intervention group

Description:

Control arm. Subjects exercise without using supplemental oxygen or NIOV.