NCT06147453

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

Effect of the Aerobika Oscillating Positive Expiratory Pressure (OPEP) Device on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Airway mucus occlusions have been identified as an important feature of asthma pathophysiology. The use of an airway clearance device may help clear such mucus plugs and consequently improve airway function and asthma control. Therefore, we will investigate the effects of daily Aerobika Oscillating Positive Expiratory Pressure (OPEP) device use in a two-centre, randomized, open-label study of adult patients with moderate-to-severe asthma that is uncontrolled with evidence of mucus plugging. 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

• Asthma

Interventions

Type	Name	Description
DEVICE	Aerobika OPEP device	16 week twice daily use of the Aerobika OPEP device

Timeline

• Start date: 2024-08-27
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-11-27
• Last updated: 2024-11-29

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study