Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
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|ClinicalTrials.gov Identifier: NCT02282189|
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Oscillating Positive Expiratory Pressure (Aerobika ®)||Not Applicable|
Cough and sputum production is common in chronic obstructive pulmonary disease (COPD), both of which are associated with significant morbidity and other adverse clinical outcomes. Airway clearance techniques (ACTs) such as afforded by oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) aim to remove sputum from the lungs, however evidence of their efficacy during stable disease is unclear.
The objective of this study is to evaluate the safety and efficacy of four times daily oPEP use over 4 weeks in individuals with stable COPD. The oPEP device combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy enforces a resistance to exhalation at the mouth while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucus. An adjustable dial allows users to adjust the frequency and the flow resistance based on their individual needs. Subjects will take a device home and use four times daily during the active part of the study. We hypothesize that daily (Aerobika ®) 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.
This is a randomized cross-over unblinded study in 15 subjects with COPD. All subjects will cross-over at four weeks of oPEP therapy or four weeks of no therapy. Each subject will visit the centre on five occasions (baseline, 2 weeks, 4 weeks (cross-over), 6 weeks and 8 weeks) for one hour each and will perform: 1) spirometry and plethysmography, 2) six-minute walk test (6MWT), and 3) health status evaluation using a self-administered St. George's Respiratory Questionnaire (SGRQ). Subjects will first provide written informed consent and will complete: 1) SGRQ after inhaling 2-4 puffs (200-400µg) of the short-acting bronchodilator (eg. Salbutamol), 2) plethysmography and spirometry 35±5 minutes post-salbutamol. Vital signs will be documented and subjects will rest for approximately 15 minutes before completing the six-minute walk test (6MWT) post-salbutamol. Subjects will be given an oPEP therapy system (Aerobika ®) to use at home, four times per day. Instruction and training on the use of the device will be given at the baseline visit. Subjects will be required to return the device upon completion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Off/on for 4 weeks followed by on/off for 4 weeks
Subjects are randomized to either Oscillating Positive Expiratory Pressure device or no device for four weeks, then crossover for the following four weeks.
Device: Oscillating Positive Expiratory Pressure (Aerobika ®)
The oPEP system combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy enforces a resistance to exhalation at the mouth, while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucous. Subjects will take home the device and use four times daily during the active part of the study.
Other Name: oPEP
- Change in Sputum Production [ Time Frame: Weekly for eight weeks ]Change in sputum production from subject self-reported questionnaires performed weekly
- Six Minute Walk Distance (6MWD) [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
- Pulmonary function measurements [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]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)
- St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
- Dyspnea (Patient Evaluation Questionnaire) [ Time Frame: Completed weekly for 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282189
|Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre|
|London, Ontario, Canada, N6A 5B7|
|Principal Investigator:||Grace E Parraga, PhD||Robarts Research Institute, The University of Western Ontario|
|Principal Investigator:||David G McCormack, MD||London Health Sciences Centre|