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

Asthma Clinical Trial

— AeroMUC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147453
• Other study ID #: FIRH-Xe011
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: St. Joseph's Healthcare Hamilton
• Contact: Sarah Svenningsen, PhD
• Phone: 19055221155
• Email: svennins[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able and willing to provide written informed consent.

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.

5. ICS dose =500 mcg of fluticasone equivalent/day. Patients on prednisone or biologic for =3 months would not be excluded as long as they meet the rest of the inclusion criteria.

6. ACQ =1.5 during the screening period.

7. CT mucus score =4 during the screening period.

Exclusion Criteria:

1. Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks.

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Aerobika OPEP device
16 week twice daily use of the Aerobika OPEP device

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Trudell Medical International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sputum rheology	Change from screening/baseline (week 0) to week 16 in expectorated sputum rheology (critical stress, elastic modulus, viscous modules)	16 weeks
Other	Mucin proteins in sputum	Change from screening/baseline (week 0) to week 16 in mucin proteins in sputum (MUAC5, MUCSB, MUC5AC:MUC5B ratio).	16 weeks
Primary	Computed Tomography (CT) mucus score	Change in the CT mucus score between screening/baseline (week 0) and week 16. Mucus scores range from 0 (best outcome) to 20 (worst outcome).	16 weeks
Secondary	MRI ventilation defect percent (VDP)	Change in MRI VDP between screening/baseline (week 0) and week 16.	16 weeks
Secondary	Forced expiratory volume in one second (FEV1)	Change in FEV1 between screening/baseline (week 0) and week 16.	16 weeks
Secondary	Asthma Control Questionnaire-5 (ACQ-5)	Change in ACQ-5 between screening/baseline (week 0) and week 16. ACQ-5 ranges from 0 (best outcome) to 5 (worst outcome).	16 weeks
Secondary	Asthma Quality of Life Questionnaire (AQLQ)	Change in AQLQ between screening/baseline (week 0) and week 16. AQLQ ranges from 1 (worst outcome) to 7 (best outcome).	16 weeks
Secondary	Asthma Control Test (ACT)	Change in ACT between screening/baseline (week 0) and week 16. ACT ranges from 5 (worst outcome) to 25 (best outcome).	16 weeks
Secondary	Cough and Sputum Assessment Questionnaire (CASA-Q)	Change in CASA-Q between screening/baseline (week 0) and week 16. The scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.	16 weeks
Secondary	St. George's Respiratory Questionnaire (SGRQ)	Change in SGRQ between screening/baseline (week 0) and week 16. SGRQ scores range from 0 to 100, with higher scores indicating more limitations.	16 weeks
Secondary	fraction of exhaled nitric oxide (FeNO)	Change in FeNO between screening/baseline (week 0) and week 16.	16 weeks
Secondary	blood eosinophil count	Change in blood eosinophil count between screening/baseline (week 0) and week 16.	16 weeks
Secondary	sputum eosinophil percent	Change in sputum eosinophil percent between screening/baseline (week 0) and week 16.	16 weeks
Secondary	sputum neutrophil percent	Change in sputum neutrophil percent between screening/baseline (week 0) and week 16.	16 weeks
Secondary	inspiratory CT wall area percent (WA%)	Change in CT WA% between screening/baseline (week 0) and week 16.	16 weeks
Secondary	inspiratory CT lumen area (LA)	Change in CT LA between screening/baseline (week 0) and week 16.	16 weeks
Secondary	respiratory system resistance (Rrs) at 5Hz	Change in Rrs5Hz between screening/baseline (week 0) and week 16.	16 weeks
Secondary	respiratory system reactance (Xrs) at 5Hz	Change in Xrs5Hz between screening/baseline (week 0) and week 16.	16 weeks
Secondary	respiratory system resistance (Rrs) at 19Hz	Change in Rrs19Hz between screening/baseline (week 0) and week 16.	16 weeks
Secondary	frequency dependence of Rrs (Rrs5-19Hz)	Change in Rrs5-19Hz between screening/baseline (week 0) and week 16.	16 weeks
Secondary	integrated area of low frequency reactance (AX)	Change in AX between screening/baseline (week 0) and week 16.	16 weeks