Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Oscillating Positive Expiratory Pressure (Aerobika ®)
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): oPEP
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sputum; Airway clearance therapy; Oscillatory Positive Expiratory Pressure; Chronic Obstructive Pulmonary Disease