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

Effect of the Aerobika Oscillating Positive Expiratory Pressure (OPEP) Device on Mucus Plugging and Airflow Obstruction in Patients With Moderate-to-severe Asthma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Device: Aerobika OPEP device

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Svenningsen, PhD; Phone Number: 19055221155; Email: svennins@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
      • Principal Investigator: Sarah Svenningsen, PhD
      • Contact: Sarah Svenningsen, PhD; Phone Number: (519) 428-4442; Email: svennins@mcmaster.ca
      • Contact: Yonni Friedlander, PhD; Phone Number: 647-967-7717; Email: yfriedla@stjoes.ca
    • London, Ontario, Canada, N6A 3K7
      • Western University
      • Contact: Angela Wilson, RRT; Phone Number: 24197 519-931-5777; Email: awilson@robarts.ca
      • Contact: Grace Parraga, PhD; Phone Number: (519) 931-5265; Email: gparraga@uwo.ca
      • Principal Investigator: Grace Parraga, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Aerobika OPEP device; 16 week twice daily use of the Aerobika OPEP device
No Intervention: Standard of care; Standard of care management for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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
integrated area of low frequency reactance (AX)	Change in AX between screening/baseline (week 0) and week 16.	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
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

Other Outcome Measures

Outcome Measure	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).	16 weeks

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Trudell Medical International

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: FIRH-Xe011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes