CompletedNot Applicable

The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD

Canada32 participantsStarted 2025-05-22

Plain-language summary

The goal of this non-pharmacologic interventional study is to learn if Oscillatory Positive Expiratory Pressure (OPEP) therapy can improve disease impact and respiratory system dynamics in patients with COPD. The main questions it aims to answer are: Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score? Is OPEP therapy able to improve the properties of the lung (called reactance) as measured by oscillometry? Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics. * Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device. * These participants will then use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks. * Finally, these participants will return to complete in-person end-of-study tests.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females 40 years of age or more
. Former/current smokers with a cigarette smoking history for 10 or more pack-years
. Physician diagnosis of COPD previously confirmed by spirometry (FEV1/FVC less than 0.7) with 'mild' to 'very severe' (i.e. GOLD 1-4) COPD
. Chronic bronchitis phenotype: Sputum production or presence of productive cough greater than 2 days/week in the last 3 months for at least 2 consecutive years, or presence of cough and phlegm almost every day or several times per week
. Ability to participate without supplemental oxygen during all oscillometry testing
. Ability to provide informed consent

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cough Impact Domain of the CASA-Q (co-primary outcome)

Timeframe: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).

Reactance at 5 Hertz (Hz) (co-primary outcome)

Timeframe: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).

Trial details

NCT IDNCT06614959

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More COPD trials

Plain-language summary

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females 40 years of age or more
. Former/current smokers with a cigarette smoking history for 10 or more pack-years
. Physician diagnosis of COPD previously confirmed by spirometry (FEV1/FVC less than 0.7) with 'mild' to 'very severe' (i.e. GOLD 1-4) COPD
. Chronic bronchitis phenotype: Sputum production or presence of productive cough greater than 2 days/week in the last 3 months for at least 2 consecutive years, or presence of cough and phlegm almost every day or several times per week
. Ability to participate without supplemental oxygen during all oscillometry testing
. Ability to provide informed consent

Exclusion criteria

What they're measuring

Cough Impact Domain of the CASA-Q (co-primary outcome)

Timeframe: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).

Reactance at 5 Hertz (Hz) (co-primary outcome)

Timeframe: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).