NCT06614959 The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD
| NCT ID | NCT06614959 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-05-22 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Males and females 40 years of age or more 2. Former/current smokers with a cigarette smoking history for 10 or more pack-years 3. 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 4. 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 5. Ability to participate without supplemental oxygen during all oscillometry testing 6. Ability to provide informed consent Exclusion Criteria: 1. No COPD diagnosis 2. Bronchiectasis, cystic fibrosis, or any other known suppurative acute/chronic lung disease as the principal respiratory condition 3. Physician-diagnosed exacerbation and/or hospitalization for pulmonary symptoms in the 4 weeks preceding baseline testing 4. Current use of OPEP, or any use of OPEP in the 4 weeks preceding baseline testing 5. Current or recent participation in a standard Pulmonary Rehabilitation program in the 4 weeks preceding baseline testing or during the study
Contact & Investigator
Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)
PRINCIPAL INVESTIGATOR
RI-MUHC/MUHC
Frequently Asked Questions
Who can join the NCT06614959 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06614959 currently recruiting?
Yes, NCT06614959 is actively recruiting participants. Contact the research team at bryan.ross@mcgill.ca for enrollment information.
Where is the NCT06614959 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06614959 clinical trial?
NCT06614959 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Bryan A. Ross, MD, MSc (Physiol), MSc (Epi) at RI-MUHC/MUHC. The trial plans to enroll 32 participants.
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