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

St. Joseph's Healthcare Hamilton

Status: Invitation-only

Conditions: Asthma

Treatments: Device: Aerobika OPEP device

Study type: Interventional

Funder types: Other

Identifiers

NCT06147453

FIRH-Xe011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Aerobika OPEP device

Active Comparator group

Description:

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.

Treatment:

Device: Aerobika OPEP device

Standard of care

No Intervention group

Description:

Standard of care management for 16 weeks.