Status:
COMPLETED
Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
London Health Sciences Centre
Conditions:
Chronic Obstructive Pulmonary Disease
Bronchiectasis
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of four times daily Positive Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three weeks in individuals with bronchiectasis and ...
Detailed Description
Cough and sputum production are common in Bronchiectasis and chronic obstructive pulmonary disease (COPD), both of which are associated with significant morbidity and other adverse clinical outcomes. ...
Eligibility Criteria
Inclusion
- Subjects male and female aged 40-85 with either a clinical diagnosis of bronchiectasis or COPD with chronic bronchitis and chronic mucous production identified
- Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
- Subject is judged to be in otherwise stable health on the basis of medical history
- Subject is ambulatory and can perform the 6MWT
- Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
- FEV1 \>25% predicted -FVC \> 25% predicted and \>0.5L
Exclusion
- Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material. Capacity to consent will be determined by either Dr. McCormack at the time of the clinic visit or Sandra Blamires, the study coordinator.
- Patient is unable to perform spirometry or plethysmography maneuvers
- Patient is pregnant
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02282202
Start Date
September 1 2013
End Date
September 1 2014
Last Update
June 27 2018
Active Locations (1)
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1
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada, N6A 5B7