AsthmaAeroMUCNCT06147453
Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma
A study testing Aerobika OPEP device in people with Asthma, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Aerobika OPEP device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Aug 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent.
- Able and willing to comply with the study protocol.
- Males and females ≥ 18 years of age.
- 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.
- 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.
- ACQ ≥1.5 during the screening period.
- CT mucus score ≥4 during the screening period.
Who cannot join
- Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks.
- 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.
- 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.
- Alcohol or substance abuse within 12 months prior to screening.
- 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.
- Ex-smokers with ≥ 15 pack-year smoking history.
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- 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).
- 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.
- Pregnant or breastfeeding
- Participation in any clinical trial of an investigational agent or procedure within three months prior to screening or during the study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Western University
London, Ontario, N6A 3K7
About this study
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
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.
- Conditions
- Asthma
- Being tested
- Aerobika OPEP device
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobika OPEP deviceDevice
16 week twice daily use of the Aerobika OPEP device
| Study group | Role | What they receive |
|---|---|---|
| Aerobika OPEP device | Active comparator | 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. Receives: Device: Aerobika OPEP device |
| Standard of care | No intervention | Standard of care management for 16 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks
Secondary outcomes (18)
MRI ventilation defect percent (VDP)
Change in MRI VDP between screening/baseline (week 0) and week 16.
Measured: 16 weeks
Forced expiratory volume in one second (FEV1)
Change in FEV1 between screening/baseline (week 0) and week 16.
Measured: 16 weeks
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).
Measured: 16 weeks
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).
Measured: 16 weeks
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).
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
fraction of exhaled nitric oxide (FeNO)
Change in FeNO between screening/baseline (week 0) and week 16.
Measured: 16 weeks
blood eosinophil count
Change in blood eosinophil count between screening/baseline (week 0) and week 16.
Measured: 16 weeks
sputum eosinophil percent
Change in sputum eosinophil percent between screening/baseline (week 0) and week 16.
Measured: 16 weeks
sputum neutrophil percent
Change in sputum neutrophil percent between screening/baseline (week 0) and week 16.
Measured: 16 weeks
inspiratory CT wall area percent (WA%)
Change in CT WA% between screening/baseline (week 0) and week 16.
Measured: 16 weeks
inspiratory CT lumen area (LA)
Change in CT LA between screening/baseline (week 0) and week 16.
Measured: 16 weeks
respiratory system resistance (Rrs) at 5Hz
Change in Rrs5Hz between screening/baseline (week 0) and week 16.
Measured: 16 weeks
respiratory system reactance (Xrs) at 5Hz
Change in Xrs5Hz between screening/baseline (week 0) and week 16.
Measured: 16 weeks
respiratory system resistance (Rrs) at 19Hz
Change in Rrs19Hz between screening/baseline (week 0) and week 16.
Measured: 16 weeks
frequency dependence of Rrs (Rrs5-19Hz)
Change in Rrs5-19Hz between screening/baseline (week 0) and week 16.
Measured: 16 weeks
integrated area of low frequency reactance (AX)
Change in AX between screening/baseline (week 0) and week 16.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start27 Aug 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Trudell Medical International
- Responsible party
- Principal investigator, Sarah Svenningsen, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147453
- Sponsor's protocol ID
- FIRH-Xe011
- Acronym
- AeroMUC
- Status last verified
- Jun 2024
- First submitted
- 15 Nov 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06147453
- Acronym / sponsor ID
- AeroMUC / FIRH-Xe011
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Trudell Medical International
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobika OPEP device | Active comparator | Device: Aerobika OPEP deviceThe 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. |
| Standard of care | No intervention | –Standard of care management for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide written informed consent.
- Able and willing to comply with the study protocol.
- Males and females ≥ 18 years of age.
- 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.
- 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.
Key exclusion criteria (10 listed)
- Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks.
- 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.
- 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.
- Alcohol or substance abuse within 12 months prior to screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobika OPEP device16 week twice daily use of the Aerobika OPEP device | Device | Aerobika OPEP device |
Primary outcome
Computed Tomography (CT) mucus score
Time frame: 16 weeks
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).
18 secondary outcomes
MRI ventilation defect percent (VDP)
Time frame: 16 weeks
Forced expiratory volume in one second (FEV1)
Time frame: 16 weeks
Asthma Control Questionnaire-5 (ACQ-5)
Time frame: 16 weeks
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 16 weeks
Asthma Control Test (ACT)
Time frame: 16 weeks
Cough and Sputum Assessment Questionnaire (CASA-Q)
Time frame: 16 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 16 weeks
fraction of exhaled nitric oxide (FeNO)
Time frame: 16 weeks
blood eosinophil count
Time frame: 16 weeks
sputum eosinophil percent
Time frame: 16 weeks
sputum neutrophil percent
Time frame: 16 weeks
inspiratory CT wall area percent (WA%)
Time frame: 16 weeks
inspiratory CT lumen area (LA)
Time frame: 16 weeks
respiratory system resistance (Rrs) at 5Hz
Time frame: 16 weeks
respiratory system reactance (Xrs) at 5Hz
Time frame: 16 weeks
respiratory system resistance (Rrs) at 19Hz
Time frame: 16 weeks
frequency dependence of Rrs (Rrs5-19Hz)
Time frame: 16 weeks
integrated area of low frequency reactance (AX)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobika OPEP device in people with Asthma, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed Tomography (CT) mucus score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.