Clinical trial NCT06147453: Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma
Official title: Effect of the Aerobika Oscillating Positive Expiratory Pressure (OPEP) Device on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Asthma
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Trudell Medical International
First posted: 2023-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Computed Tomography (CT) mucus score
timeFrame: 16 weeks
Secondary outcomes:
measure: MRI ventilation defect percent (VDP)
timeFrame: 16 weeks
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 16 weeks
measure: Asthma Control Questionnaire-5 (ACQ-5)
timeFrame: 16 weeks
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 16 weeks
measure: Asthma Control Test (ACT)
timeFrame: 16 weeks
measure: Cough and Sputum Assessment Questionnaire (CASA-Q)
timeFrame: 16 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 16 weeks
measure: fraction of exhaled nitric oxide (FeNO)
timeFrame: 16 weeks
measure: blood eosinophil count
timeFrame: 16 weeks
measure: sputum eosinophil percent
timeFrame: 16 weeks
measure: sputum neutrophil percent
timeFrame: 16 weeks
measure: inspiratory CT wall area percent (WA%)
timeFrame: 16 weeks
measure: inspiratory CT lumen area (LA)
timeFrame: 16 weeks
measure: respiratory system resistance (Rrs) at 5Hz
timeFrame: 16 weeks
measure: respiratory system reactance (Xrs) at 5Hz
timeFrame: 16 weeks
measure: respiratory system resistance (Rrs) at 19Hz
timeFrame: 16 weeks
measure: frequency dependence of Rrs (Rrs5-19Hz)
timeFrame: 16 weeks
measure: integrated area of low frequency reactance (AX)
timeFrame: 16 weeks
Other outcomes:
measure: Sputum rheology
timeFrame: 16 weeks
measure: Mucin proteins in sputum
timeFrame: 16 weeks
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
References: