Effects of OPEP therapy on COPD symptoms and lung function
Assessing the Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy on Disease Impact and Respiratory System Dynamics in Patients With COPD: A Prospective Non-Pharmacologic Interventional Cohort Study
This study is testing if using a special breathing device at home for four weeks can help people with COPD and chronic bronchitis breathe better and feel less cough.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06614959 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the impact of Oscillatory Positive Expiratory Pressure (OPEP) therapy on patients with Chronic Obstructive Pulmonary Disease (COPD), specifically those with a chronic bronchitis phenotype. Participants will use a smart OPEP device at home for four weeks, performing the therapy at least twice daily. The study will measure changes in cough symptoms and lung mechanics before and after the treatment period using validated scoring systems and oscillometry. The goal is to determine if OPEP therapy can significantly improve respiratory function and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a physician-confirmed diagnosis of COPD and a chronic bronchitis phenotype.
Not a fit: Patients without a COPD diagnosis or those with other significant lung diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could lead to improved respiratory function and reduced cough symptoms for patients with COPD.
How similar studies have performed: While studies on OPEP therapy are limited, similar non-pharmacologic interventions have shown promise in improving respiratory outcomes in COPD patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Bryan A. Ross, MD, MSc (Physiol), MSc (Epi) — Ri-Muhc/muhc
- Study coordinator: Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)
- Email: bryan.ross@mcgill.ca
- Phone: (514) 843-1465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.