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

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of four times daily Positive
      Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three weeks in individuals with
      bronchiectasis and chronic obstructive pulmonary disease (COPD) with chronic sputum
      production. The investigators hypothesize that four times daily positive expiratory pressure
      using the Aerobika ® will significantly improve dyspnea, movement of mucus, St. George's
      Respiratory Questionnaire (SGRQ) score, and six-minute walk distance (6MWD) after three weeks
      of four times daily administration.
    

Detailed description: 
      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.
    

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