N/A
N=15
Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01372462 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions — 6.3; 17.5; 11.4; 5.6 minutes — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NIOV - Room Air (Device); NIOV - Oxygen (Device); Nasal Cannula Oxygen (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Breathe Technologies, Inc.
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions |
6.3; 17.5; 11.4; 5.6 | <0.05 sig |
| SECONDARY SpO2 During Constant Workrate Exercise at Isotime |
87.9; 98.5; 92.7; 88.2 | < 0.05 sig |
| SECONDARY Borg Dyspnea Score During Constant Workrate Exercise at Isotime |
3.3; 1.8; 2.5; 4.6 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Adult males, ≥ 40 years of age
- Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 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
Data sourced from ClinicalTrials.gov (NCT01372462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.