Clinical trial NCT06614959: The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Keywords: COPD
OPEP
Chronic Bronchitis
Disease Impact
Reactance
CASA-Q Questionnaire
Oscillometry
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Trudell Medical International
First posted: 2024-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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

Primary outcomes:
measure: 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).
measure: 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).
Secondary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Sputum Impact
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: The reactance-volume loop area (AXV)
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Mean inspiratory minus expiratory total respiratory system reactance (mean ∆Xrs)
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Area of reactance (Ax)
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Resonant frequency (Fres)
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Sputum Symptom Severity
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Cough Symptom Severity
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: Cough Impact
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
measure: The difference between resistance at 5 Hertz (R5) and resistance at 20 Hertz (R20) (R5-20)
timeFrame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: RI-MUHC/MUHC
name: Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)
role: PRINCIPAL_INVESTIGATOR
References: