OPEP Device for Asthma

(AeroMUC Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the Aerobika OPEP device in helping people with moderate-to-severe asthma. The device clears mucus and improves breathing by creating pressure and vibrations during exhalation. Participants will use the device twice daily for 16 weeks, while others will continue their usual asthma care. Individuals with asthma for over a year who experience regular breathing problems may be suitable candidates. The goal is to determine if this device can simplify and enhance asthma management. As an unphased trial, this study allows participants to contribute to innovative asthma management research.

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.

What prior data suggests that this OPEP device is safe for asthma patients?

Research shows that the Aerobika OPEP device is generally safe for use. Studies have found that it can greatly improve breathing for those with lung problems. For instance, one study discovered that using the Aerobika OPEP device led to fewer hospital visits and severe flare-ups, indicating its effectiveness in managing lung health. Another study showed that after just 12 weeks of use, air flowed more easily through small lung passages. These findings strongly support the Aerobika OPEP device's safety and efficacy for people with breathing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Aerobika OPEP device for asthma because it combines positive expiratory pressure with airway vibrations to help clear mucus from the lungs. Unlike standard asthma treatments that focus on medications like inhaled corticosteroids and bronchodilators to reduce inflammation and open airways, this device offers a mechanical approach to managing symptoms. By enforcing resistance during exhalation, the OPEP device helps mobilize and expel mucus, potentially improving lung function and reducing asthma symptoms in a new way.

What evidence suggests that the Aerobika OPEP device is effective for asthma?

Research has shown that the Aerobika OPEP device, which participants in this trial may use, improves airway function by reducing resistance in the small airways. Studies have found that using this device can ease breathing and enhance quality of life. For individuals with breathing problems, the Aerobika device has resulted in fewer emergency room visits and hospital stays. This suggests it can help manage asthma by clearing mucus from the airways. Overall, these findings support the Aerobika OPEP device's potential to treat asthma symptoms effectively. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Industry Sponsor

Trudell Medical International

Collaborator

Trials

4

Recruited

330+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272579/

Impact of Aerobika® oscillating positive expiratory pressure in ... Aerobika OPEP demonstrated significant improvement in small airway resistance as early as 12 weeks of usage, with sustained improvement at 24 weeks.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6966948/

A Real-World Evidence Study Assessing the Impact of ... Clinical trial results have demonstrated that use of the Aerobika OPEP device significantly improves dyspnea, quality of life, exercise capacity and ease in ...

3. link.springer.com link.springer.com/article/10.1007/s41030-017-0027-5

A Real-World Study of 30-Day Exacerbation Outcomes in ... Study findings suggest that using Aerobika OPEP as part of a treatment regimen may help reduce ED visits, hospital re-admissions and related costs in COPD ...

4. trudellmed.com trudellmed.com/sites/default/files/documents/aerobika-opep-study-summary-2024.pdf

Study Summary Results: For a patient after 1 year, the use of the. Aerobika® device would save $694 in healthcare costs and produce 0.04 more in quality-adjusted life years.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05420740

Impact of Aerobika OPEP in Improving Small Airway ... To demonstrate change of small airway parameter using impulse oscillometry after introduction of Aerobika® OPEP among COPD patients . Comparing change of small ...

6. tandfonline.com tandfonline.com/doi/full/10.2147/COPD.S256866

Impact of Oscillating Positive Expiratory Pressure Device ... This study demonstrates that the Aerobika OPEP device significantly reduces all-cause inpatient visits and severe disease exacerbations, ...