Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
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.
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.
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