Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma
NCT ID: NCT06147453
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2024-08-27
2025-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Aerobika OPEP device
16 week twice daily use of the Aerobika OPEP device
Standard of care
Standard of care management for 16 weeks.
No interventions assigned to this group
Interventions
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Aerobika OPEP device
16 week twice daily use of the Aerobika OPEP device
Eligibility Criteria
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Inclusion Criteria
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.
6. ACQ ≥1.5 during the screening period.
7. CT mucus score ≥4 during the screening period.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Trudell Medical International
INDUSTRY
St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Sarah Svenningsen
Principal Investigator
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Western University
London, Ontario, Canada
Countries
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Other Identifiers
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FIRH-Xe011
Identifier Type: -
Identifier Source: org_study_id