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| Name | Class |
|---|---|
| Trudell Medical International | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobika OPEP device | Active Comparator | The OPEP system (Aerobika®) combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. OPEP therapy (Aerobika ®) enforces 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. Participants will take home the device and use it twice daily for 16 weeks. |
|
| Standard of care | No Intervention | Standard of care management for 16 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobika OPEP device | Device | 16 week twice daily use of the Aerobika OPEP device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MRI ventilation defect percent (VDP) | Change in MRI VDP between screening/baseline (week 0) and week 16. | 16 weeks |
| Forced expiratory volume in one second (FEV1) | Change in FEV1 between screening/baseline (week 0) and week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum rheology | Change from screening/baseline (week 0) to week 16 in expectorated sputum rheology (critical stress, elastic modulus, viscous modules) | 16 weeks |
| Mucin proteins in sputum | Change from screening/baseline (week 0) to week 16 in mucin proteins in sputum (MUAC5, MUCSB, MUC5AC:MUC5B ratio). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada | ||
| Western University |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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). | 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). | 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). | 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. | 16 weeks |
| 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. | 16 weeks |
| fraction of exhaled nitric oxide (FeNO) | Change in FeNO between screening/baseline (week 0) and week 16. | 16 weeks |
| blood eosinophil count | Change in blood eosinophil count between screening/baseline (week 0) and week 16. | 16 weeks |
| sputum eosinophil percent | Change in sputum eosinophil percent between screening/baseline (week 0) and week 16. | 16 weeks |
| sputum neutrophil percent | Change in sputum neutrophil percent between screening/baseline (week 0) and week 16. | 16 weeks |
| inspiratory CT wall area percent (WA%) | Change in CT WA% between screening/baseline (week 0) and week 16. | 16 weeks |
| inspiratory CT lumen area (LA) | Change in CT LA between screening/baseline (week 0) and week 16. | 16 weeks |
| respiratory system resistance (Rrs) at 5Hz | Change in Rrs5Hz between screening/baseline (week 0) and week 16. | 16 weeks |
| respiratory system reactance (Xrs) at 5Hz | Change in Xrs5Hz between screening/baseline (week 0) and week 16. | 16 weeks |
| respiratory system resistance (Rrs) at 19Hz | Change in Rrs19Hz between screening/baseline (week 0) and week 16. | 16 weeks |
| frequency dependence of Rrs (Rrs5-19Hz) | Change in Rrs5-19Hz between screening/baseline (week 0) and week 16. | 16 weeks |
| integrated area of low frequency reactance (AX) | Change in AX between screening/baseline (week 0) and week 16. | 16 weeks |
| 16 weeks |
| London |
| Ontario |
| N6A 3K7 |
| Canada |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |