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

NCT ID: NCT06614959

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2026-09-30

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oscillatory Positive Expiratory Pressure (OPEP) therapy arm

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

Group Type: EXPERIMENTAL

Oscillatory Positive Expiratory Pressure (OPEP) Therapy

Intervention Type: 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.

Interventions

Oscillatory Positive Expiratory Pressure (OPEP) Therapy

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trudell Medical International

INDUSTRY

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Bryan A. Ross

Clinician-Scientist (RI-MUHC), Respirologist (MUHC), Assistant Professor (McGill University)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

RI-MUHC/MUHC

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

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

Role: CONTACT

bryan.ross@mcgill.ca

(514) 843-1465

Facility Contacts

Bryan A. Ross

Role: primary

bryan.ross@mcgill.ca

5148431465

Other Identifiers

2025-10838

Identifier Type: -

Identifier Source: org_study_id