The goal of this randomized clinical trial is to evaluate the effect of daily AerobikaTM Oscillating Positive Expiratory Pressure (OPEP) device use on mucus plugging and airway function in adult patients with moderate-to-severe asthma.
Airway mucus occlusions have been identified as an important feature of asthma pathophysiology. The use of an airway clearance device may help clear such mucus plugs and consequently improve airway function and asthma control. Therefore, we will investigate the effects of daily Aerobika Oscillating Positive Expiratory Pressure (OPEP) device use in a two-centre, randomized, open-label study of adult patients with moderate-to-severe asthma that is uncontrolled with evidence of mucus plugging. The total study duration per patient will be 17 weeks, consisting of a screening period of up-to 1 week, and an open-label randomized treatment period of 16 weeks. Participants will be randomized to Aerobika use or will continue their current medications. The trial will evaluate the effect of Aerobika use on mucus plugging, airway function, and asthma control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
16 week twice daily use of the Aerobika OPEP device
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Western University
London, Ontario, Canada
Computed Tomography (CT) mucus score
Change in the CT mucus score between screening/baseline (week 0) and week 16. Mucus scores range from 0 (best outcome) to 20 (worst outcome).
Time frame: 16 weeks
MRI ventilation defect percent (VDP)
Change in MRI VDP between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
Forced expiratory volume in one second (FEV1)
Change in FEV1 between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
Asthma Control Questionnaire-5 (ACQ-5)
Change in ACQ-5 between screening/baseline (week 0) and week 16. ACQ-5 ranges from 0 (best outcome) to 5 (worst outcome).
Time frame: 16 weeks
Asthma Quality of Life Questionnaire (AQLQ)
Change in AQLQ between screening/baseline (week 0) and week 16. AQLQ ranges from 1 (worst outcome) to 7 (best outcome).
Time frame: 16 weeks
Asthma Control Test (ACT)
Change in ACT between screening/baseline (week 0) and week 16. ACT ranges from 5 (worst outcome) to 25 (best outcome).
Time frame: 16 weeks
Cough and Sputum Assessment Questionnaire (CASA-Q)
Change in CASA-Q between screening/baseline (week 0) and week 16. The scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
Time frame: 16 weeks
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St. George's Respiratory Questionnaire (SGRQ)
Change in SGRQ between screening/baseline (week 0) and week 16. SGRQ scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 16 weeks
fraction of exhaled nitric oxide (FeNO)
Change in FeNO between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
blood eosinophil count
Change in blood eosinophil count between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
sputum eosinophil percent
Change in sputum eosinophil percent between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
sputum neutrophil percent
Change in sputum neutrophil percent between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
inspiratory CT wall area percent (WA%)
Change in CT WA% between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
inspiratory CT lumen area (LA)
Change in CT LA between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
respiratory system resistance (Rrs) at 5Hz
Change in Rrs5Hz between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
respiratory system reactance (Xrs) at 5Hz
Change in Xrs5Hz between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
respiratory system resistance (Rrs) at 19Hz
Change in Rrs19Hz between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
frequency dependence of Rrs (Rrs5-19Hz)
Change in Rrs5-19Hz between screening/baseline (week 0) and week 16.
Time frame: 16 weeks
integrated area of low frequency reactance (AX)
Change in AX between screening/baseline (week 0) and week 16.
Time frame: 16 weeks