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

NCT06147453 | Enrolling By Invitation FDA Device

• 1 other identifier: FIRH-Xe011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• MRI ventilation defect percent (VDP)

  16 weeks

• Forced expiratory volume in one second (FEV1)

  16 weeks

• Asthma Control Questionnaire-5 (ACQ-5)

  16 weeks

• Asthma Quality of Life Questionnaire (AQLQ)

  16 weeks

• Asthma Control Test (ACT)

  16 weeks

Other Outcomes (2)

• Sputum rheology

  16 weeks

• Mucin proteins in sputum

  16 weeks

Study Arms (2)

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.

Device: Aerobika OPEP device

Standard of care

NO INTERVENTION

Standard of care management for 16 weeks.

Interventions

Aerobika OPEP device DEVICE

16 week twice daily use of the Aerobika OPEP device

Aerobika OPEP device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent.
• Able and willing to comply with the study protocol.
• Males and females ≥ 18 years of age.
• 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.
• ACQ ≥1.5 during the screening period.
• CT mucus score ≥4 during the screening period.

You may not qualify if:

• Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks.
• 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.
• 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.
• Alcohol or substance abuse within 12 months prior to screening.
• 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.
• Ex-smokers with ≥ 15 pack-year smoking history.
• 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).
• 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.
• Pregnant or breastfeeding
• Participation in any clinical trial of an investigational agent or procedure within three months prior to screening or during the study.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Trudell Medical International: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 27, 2023
• Study Start: August 27, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)