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

NCT06614959 · McGill University Health Centre/Research Institute of the McGill University Health Centre
In plain English

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Official title
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
About this study
The objectives of this prospective, non-pharmacologic interventional cohort study are to determine the effect of four consecutive weeks of twice-daily or greater OPEP usage among patients with COPD with a chronic bronchitis (sputum-producing) phenotype on disease impact and on respiratory system dynamics. A 'dose-response' effect of OPEP use will also be investigated. We hypothesize that a 4-week period of OPEP therapy among eligible patients with COPD with a chronic bronchitis (sputum-producing) phenotype will be associated with improved disease impact scores and airway mechanics.
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
Study design
Enrollment target: 32 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-22
Estimated completion: 2026-09-30
Last updated: 2025-05-28
Interventions
Device: Oscillatory Positive Expiratory Pressure (OPEP) Therapy
Primary outcomes
  • Cough Impact Domain of the CASA-Q (co-primary outcome) (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) (Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · other
With: Trudell Medical International
Contacts & investigators
ContactBryan A. Ross, MD, MSc (Physiol), MSc (Epi) · contact · bryan.ross@mcgill.ca · (514) 843-1465
InvestigatorBryan A. Ross, MD, MSc (Physiol), MSc (Epi) · principal_investigator, RI-MUHC/MUHC
All locations (1)
McGill University Health CentreRecruiting
Montreal, Quebec, Canada
The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD · TrialPath