OPEP Device for Asthma

(AeroMUC Trial)

Recruiting at 1 trial location

Overseen By Sarah Svenningsen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Must be taking: ICS, Prednisone, Biologics

Disqualifiers: Infections, Pulmonary diseases, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients on prednisone or biologics for at least 3 months can participate, suggesting you may continue some medications.

How does the Aerobika OPEP device treatment for asthma differ from other treatments?

The Aerobika OPEP device is unique because it is a hand-held, drug-free device that helps clear airways by creating positive pressure and air-flow oscillations during exhalation, which can improve lung function and quality of life. Unlike many asthma treatments that involve medication, this device aids in mucus clearance without drugs. ^{1 2 3 4 5}

Eligibility Criteria

Adults with moderate-to-severe asthma, diagnosed over a year ago and meeting specific criteria like an ACQ score above 1.5, certain levels of eosinophils or nitric oxide in their breath, and a CT mucus score over 4. They must be on a stable dose of inhaled corticosteroids and can't have other major lung diseases or recent substance abuse.

Inclusion Criteria

I am taking a high dose of inhaled corticosteroids or have been on prednisone or a biologic for over 3 months.

Your asthma symptoms are not well controlled during the screening period.

Able and willing to comply with the study protocol

Exclusion Criteria

I've had an asthma attack treated with steroids in the last 6 weeks.

I have a device or metal in my body that cannot be removed.

I have not needed treatment for other lung diseases in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants use the Aerobika OPEP device or continue standard care for 16 weeks

16 weeks

Participants take home the device and use it twice daily

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aerobika OPEP device

Trial Overview The trial is testing if using the Aerobika OPEP device daily improves mucus clearance and airflow in adults with serious asthma. Participants are randomly chosen to either use the device or not, allowing researchers to compare outcomes between the two groups.

Participant Groups

Group I: Aerobika OPEP device Active Control 1 Intervention

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.

Group II: Standard of care Active Control 1 Intervention

Standard of care management for 16 weeks.

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Trudell Medical International

Collaborator

Trials

4

Recruited

330+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Aerobika® oscillating positive expiratory pressure in improving small airway resistance, lung function, symptoms and exercise capacity in chronic obstructive pulmonary disease. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A Functional Respiratory Imaging Approach to the Effect of an Oscillating Positive Expiratory Pressure Device in Chronic Obstructive Pulmonary Disease. [2021]

3. Egypt pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of the Aerobika® Oscillating Positive Expiratory Pressure Device in the Management of Chronic Obstructive Pulmonary Disease Exacerbations in Canada. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Functional Characteristics of 4 Oscillatory Positive Pressure Devices in a Simulated Cystic Fibrosis Model. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Use of oscillatory positive expiratory pressure (OPEP) devices to augment sputum clearance in COPD: a systematic review and meta-analysis. [2020]