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OPEP Device for Asthma (AeroMUC Trial)

N/A
Waitlist Available
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

AeroMUC Trial Summary

This trial tests if a device can help reduce mucus plugging and improve airway function in people with asthma.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort from using the device such as coughing or throat irritation due to increased mucus movement.

AeroMUC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CT mucus score
Secondary outcome measures
Asthma Control Questionnaire-5 (ACQ-5)
Asthma Control Test (ACT)
Asthma Quality of Life Questionnaire (AQLQ)
+13 more
Other outcome measures
Mucin proteins in sputum
Sputum rheology

AeroMUC Trial Design

2Treatment groups
Active Control
Group I: Aerobika OPEP deviceActive Control1 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 careActive Control1 Intervention
Standard of care management for 16 weeks.

Find a Location

Who is running the clinical trial?

Trudell Medical InternationalUNKNOWN
2 Previous Clinical Trials
270 Total Patients Enrolled
1 Trials studying Asthma
110 Patients Enrolled for Asthma
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,514 Total Patients Enrolled
7 Trials studying Asthma
262 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for new participants to join this clinical experiment?

"Clinicaltrials.gov confirms that this study, which was initially posted on January 1st 2024 and last modified on November 15th 2023, is not currently seeking participants. Fortunately, there are 322 other clinical trials actively recruiting members at the present time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients With Moderate-to-severe Asthma
Sarah Svenningsen 2024. "Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients With Moderate-to-severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06147453.
All > Pediatric Asthma > Asthma
~20 spots leftby Jan 2025
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