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

NCT06614959 | Recruiting

• 1 other identifier: 2025-10838
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; OPEP; Chronic Bronchitis; Disease Impact; Reactance; CASA-Q Questionnaire; Oscillometry

Outcome Measures

Primary Outcomes (2)

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

  The Cough and Sputum Assessment Questionnaire (CASA-Q) is a validated tool used to assess cough and sputum symptoms in patients with COPD and has been shown to be responsive to changes in these aspects during clinical trials, and following exacerbations. 20-item questionnaire consisting of four domains. The magnitude of difference in baseline and end-of-study visit 'Cough Impact' domain from the CASA-Q score will serve as the co-primary outcome for disease impact.

  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)

  Oscillometry can detect changes in respiratory system resistance and reactance as well as flow-limited breaths. The magnitude of difference in baseline and end-of-study visit reactance of the respiratory system at 5 Hz (X5) will serve as the co-primary outcome for respiratory system dynamics.

  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 (10)

• COPD Assessment Test (CAT)

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

• Sputum Impact

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

• The reactance-volume loop area (AXV)

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

• Mean inspiratory minus expiratory total respiratory system reactance (mean ∆Xrs)

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

• Area of reactance (Ax)

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

Study Arms (1)

Oscillatory Positive Expiratory Pressure (OPEP) therapy arm

EXPERIMENTAL

Participants will receive and use the smart OPEP device at least twice a day in the home environment for 4 consecutive weeks.

Device: Oscillatory Positive Expiratory Pressure (OPEP) Therapy

Interventions

Oscillatory Positive Expiratory Pressure (OPEP) Therapy DEVICE

The smart OPEP device is a standard OPEP device equipped with an additional detachable sensor that collects diagnostic information on the total elapsed time of OPEP use, the pressure generated during use, frequency and amplitude of pressure oscillations, respiratory information (inhalations/exhalation number/time), and sum of all oscillations with a pressure over 1 centimeter of water (cmH2O), all of which will inform the duration and quality of home use.

Oscillatory Positive Expiratory Pressure (OPEP) therapy arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No COPD diagnosis
• Bronchiectasis, cystic fibrosis, or any other known suppurative acute/chronic lung disease as the principal respiratory condition
• Physician-diagnosed exacerbation and/or hospitalization for pulmonary symptoms in the 4 weeks preceding baseline testing
• Current use of OPEP, or any use of OPEP in the 4 weeks preceding baseline testing
• Current or recent participation in a standard Pulmonary Rehabilitation program in the 4 weeks preceding baseline testing or during the study

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Trudell Medical International: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)

  RI-MUHC/MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)

CONTACT

(514) 843-1465; bryan.ross@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist (RI-MUHC), Respirologist (MUHC), Assistant Professor (McGill University)

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: May 22, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)