Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
NCT number | NCT02282189 |
Other study ID # | ROB0036 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | January 2013 |
Verified date | June 2018 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of four times daily oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) use over 4 weeks in individuals with stable chronic obstructive pulmonary disease (COPD). The investigators hypothesize that daily oPEP use will significantly improve St. George's Respiratory Questionnaire (SGRQ) score, six-minute walk distance (6MWD) and forced expiratory volume in one second (FEV1) after four weeks of four times daily administration.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Subjects male and female aged 40-85 with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada | London Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Sputum Production | Change in sputum production from subject self-reported questionnaires performed weekly | Weekly for eight weeks | |
Secondary | Six Minute Walk Distance (6MWD) | Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks | ||
Secondary | Pulmonary function measurements | Pulmonary function measurements include FEV1 (Forced expiratory volume in 1 second); FVC (forced vital capacity); FEV1/FVC ratio; TLC (total lung capacity); RV (residual volume); DLCO (Diffusing capacity of the lung) | Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks | |
Secondary | St. George's Respiratory Questionnaire (SGRQ) | Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks | ||
Secondary | Dyspnea (Patient Evaluation Questionnaire) | Completed weekly for 8 weeks |
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