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Status unknownNCT06147453AeroMUCUpdated Nov 29, 2024

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

An interventional study of Aerobika OPEP device in Asthma, sponsored by St. Joseph's Healthcare Hamilton. Status unknown at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

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Lead sponsor

St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Aerobika OPEP device

    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.

    Device: Aerobika OPEP device

  • No intervention
    Standard of care

    Standard of care management for 16 weeks.

Interventions

  • DeviceAerobika OPEP device

    16 week twice daily use of the Aerobika OPEP device

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 16 weeks

Secondary outcomes

  1. MRI ventilation defect percent (VDP)

    Change in MRI VDP between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  2. Forced expiratory volume in one second (FEV1)

    Change in FEV1 between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  3. 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).

    Time frame: 16 weeks

  4. 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).

    Time frame: 16 weeks

  5. 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).

    Time frame: 16 weeks

  6. 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.

    Time frame: 16 weeks

  7. 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.

    Time frame: 16 weeks

  8. fraction of exhaled nitric oxide (FeNO)

    Change in FeNO between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  9. blood eosinophil count

    Change in blood eosinophil count between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  10. sputum eosinophil percent

    Change in sputum eosinophil percent between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  11. sputum neutrophil percent

    Change in sputum neutrophil percent between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  12. inspiratory CT wall area percent (WA%)

    Change in CT WA% between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  13. inspiratory CT lumen area (LA)

    Change in CT LA between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  14. respiratory system resistance (Rrs) at 5Hz

    Change in Rrs5Hz between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  15. respiratory system reactance (Xrs) at 5Hz

    Change in Xrs5Hz between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  16. respiratory system resistance (Rrs) at 19Hz

    Change in Rrs19Hz between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  17. frequency dependence of Rrs (Rrs5-19Hz)

    Change in Rrs5-19Hz between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

  18. integrated area of low frequency reactance (AX)

    Change in AX between screening/baseline (week 0) and week 16.

    Time frame: 16 weeks

Other outcomes

  1. Sputum rheology

    Change from screening/baseline (week 0) to week 16 in expectorated sputum rheology (critical stress, elastic modulus, viscous modules)

    Time frame: 16 weeks

  2. Mucin proteins in sputum

    Change from screening/baseline (week 0) to week 16 in mucin proteins in sputum (MUAC5, MUCSB, MUC5AC:MUC5B ratio).

    Time frame: 16 weeks

07

Study locations

2 sites
  • St. Joseph's Healthcare Hamilton
    Hamilton, Ontario L8N 4A6, Canada
  • Western University
    London, Ontario N6A 3K7, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Jul 2025, 10 months after the start.

Of 466 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 10 months is below that.

Counting every sponsor, half of 502 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2023
First posted
Nov 27, 2023
StartActual
Aug 27, 2024
Primary completionEst.
Jul 1, 2025
CompletionEst.
Jul 1, 2025
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06147453
Lead sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Trudell Medical International
Responsible party
Sarah Svenningsen (Principal Investigator, St. Joseph's Healthcare Hamilton) — Principal investigator
First posted
Nov 27, 2023
Start date
Aug 27, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Nov 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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