Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD
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|ClinicalTrials.gov Identifier: NCT02282202|
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease Bronchiectasis||Device: Oscillating Positive Expiratory Pressure (Aerobika ®)||Not Applicable|
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. 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 Positive Expiratory Pressure maneuvers over three weeks in individuals with bronchiectasis and COPD with chronic sputum production. The oPEP device (Aerobika ®) 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 oPEP use will significantly improve dyspnea, movement of mucus, SGRQ score, and 6MWD after three weeks of four times daily administration.
This is a randomized cross-over unblinded study in 30 subjects: ten with bronchiectasis and 20 with COPD (with chronic bronchitis and chronic mucus production identified). Five subjects from the Bronchiectasis group and ten from the COPD group will start with oPEP and use for three weeks. All subjects will crossover at Visit Two after three weeks of oPEP therapy or three weeks of no therapy. Each subject will visit the centre on three occasions: Baseline, Crossover Visit, and Final Visit for approximately one hour each and will perform: 1) spirometry and plethysmography, 2) 6MWT, and 3) health status evaluation using a self-administered 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 (±five minutes) post-salbutamol. Vital signs will be documented and subjects will rest for approximately 15 minutes before 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 :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Off/on for 3 weeks followed by on/off for 3 weeks
Subjects are randomized to either Oscillating Positive Expiratory Pressure device (Aerobika ®) or no device for three weeks, then crossover for the following three weeks.
Device: Oscillating Positive Expiratory Pressure (Aerobika ®)
The oPEP system (Aerobika ®) combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy (Aerobika ®) 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.
There is only one intervention for this study. Subjects are "on" treatment for three weeks and "off" for the alternate three weeks.
Other Name: oPEP (Aerobika ®)
- Change in sputum production [ Time Frame: weekly for six weeks ]Change in sputum production from subject self-reported questionnaires performed weekly
- Six Minute Walk Distance (6MWD) [ Time Frame: Baseline, 3-weeks (cross-over), 6-weeks ]
- Pulmonary function measurements [ Time Frame: Baseline, 3-weeks (cross-over), 6-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, 3-weeks (cross-over), 6-weeks ]
- Dyspnea (Patient Evaluation Questionnaire) [ Time Frame: Completed weekly for 6 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): NCT02282202
|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|