Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma

Not Applicable

• Conditions: Asthma
• Interventions: Device: Aerobika OPEP device

• Registration Number: NCT06147453
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-27
• Status Verified: 2024-06
• Study Start: 2024-08-27
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Able and willing to provide written informed consent.
2. Able and willing to comply with the study protocol.
3. Males and females ≥ 18 years of age.
4. Asthma diagnosed by a respiratory physician ≥12 months prior to study enrolment based on the Global Initiative for Asthma (GINA) 2014 guidelines - GINA 4 or 5.
5. ICS dose ≥500 mcg of fluticasone equivalent/day. Patients on prednisone or biologic for ≥3 months would not be excluded as long as they meet the rest of the inclusion criteria.
6. ACQ ≥1.5 during the screening period.
7. CT mucus score ≥4 during the screening period.

Exclusion Criteria

1. Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks.
2. Acute asthma exacerbation event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to screening.
3. Other relevant pulmonary diseases (e.g., chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to screening.
4. Alcohol or substance abuse within 12 months prior to screening.
5. Current smoker defined as having smoked at least one cigarette (or pipe, cigar, or cannabis) per day for ≥ 30 days within the three months prior to screening.
6. Ex-smokers with ≥ 15 pack-year smoking history.
7. Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
8. In the investigator's opinion, subject suffers from any physical, psychological, or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
9. Pregnant or breastfeeding
10. Participation in any clinical trial of an investigational agent or procedure within three months prior to screening or during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobika OPEP device	Aerobika OPEP device	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.

Primary Outcome Measures

Name	Time	Method
Computed Tomography (CT) mucus score	16 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Asthma Quality of Life Questionnaire (AQLQ)	16 weeks	Change in AQLQ between screening/baseline (week 0) and week 16. AQLQ ranges from 1 (worst outcome) to 7 (best outcome).
MRI ventilation defect percent (VDP)	16 weeks	Change in MRI VDP between screening/baseline (week 0) and week 16.
sputum neutrophil percent	16 weeks	Change in sputum neutrophil percent between screening/baseline (week 0) and week 16.
St. George's Respiratory Questionnaire (SGRQ)	16 weeks	Change in SGRQ between screening/baseline (week 0) and week 16. SGRQ scores range from 0 to 100, with higher scores indicating more limitations.
Forced expiratory volume in one second (FEV1)	16 weeks	Change in FEV1 between screening/baseline (week 0) and week 16.
Asthma Control Questionnaire-5 (ACQ-5)	16 weeks	Change in ACQ-5 between screening/baseline (week 0) and week 16. ACQ-5 ranges from 0 (best outcome) to 5 (worst outcome).
Asthma Control Test (ACT)	16 weeks	Change in ACT between screening/baseline (week 0) and week 16. ACT ranges from 5 (worst outcome) to 25 (best outcome).
fraction of exhaled nitric oxide (FeNO)	16 weeks	Change in FeNO between screening/baseline (week 0) and week 16.
Cough and Sputum Assessment Questionnaire (CASA-Q)	16 weeks	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.
blood eosinophil count	16 weeks	Change in blood eosinophil count between screening/baseline (week 0) and week 16.
respiratory system resistance (Rrs) at 5Hz	16 weeks	Change in Rrs5Hz between screening/baseline (week 0) and week 16.
respiratory system resistance (Rrs) at 19Hz	16 weeks	Change in Rrs19Hz between screening/baseline (week 0) and week 16.
integrated area of low frequency reactance (AX)	16 weeks	Change in AX between screening/baseline (week 0) and week 16.
sputum eosinophil percent	16 weeks	Change in sputum eosinophil percent between screening/baseline (week 0) and week 16.
respiratory system reactance (Xrs) at 5Hz	16 weeks	Change in Xrs5Hz between screening/baseline (week 0) and week 16.
inspiratory CT wall area percent (WA%)	16 weeks	Change in CT WA% between screening/baseline (week 0) and week 16.
inspiratory CT lumen area (LA)	16 weeks	Change in CT LA between screening/baseline (week 0) and week 16.
frequency dependence of Rrs (Rrs5-19Hz)	16 weeks	Change in Rrs5-19Hz between screening/baseline (week 0) and week 16.

Trial Locations

Locations (2)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Western University; 🇨🇦 London, Ontario, Canada