COPDNCT06614959

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

A study testing Oscillatory Positive Expiratory Pressure (OPEP) Therapy in people with COPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: Oscillatory Positive Expiratory Pressure (OPEP) Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: 22 May 2025to 30 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

McGill University Health Centre
Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

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

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.

Read the 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
Being tested: Oscillatory Positive Expiratory Pressure (OPEP) Therapy
Keywords: COPD, OPEP, Chronic Bronchitis, Disease Impact, Reactance, CASA-Q Questionnaire, Oscillometry
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oscillatory Positive Expiratory Pressure (OPEP) TherapyDevice
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.

Study groups in NCT06614959
Study group	Role	What they receive
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. Receives: Device: Oscillatory Positive Expiratory Pressure (OPEP) Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
The CAT is a validated self-administered questionnaire that is used for assessing and monitoring symptom burden and health-related quality of life in patients with COPD.
Measured: 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
Sputum Impact domain (6 items) of the CASA-Q Questionnaire.
Measured: 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)
Measurement obtained from intra-breath oscillometry.
Measured: 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)
Measurement obtained from intra-breath oscillometry.
Measured: 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)
Measurement obtained from oscillometry.
Measured: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Resonant frequency (Fres)
Measurement obtained from oscillometry.
Measured: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Sputum Symptom Severity
Sputum Symptom Severity Domain (3 items) of the CASA-Q Questionnaire
.
Measured: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Cough Symptom Severity
Cough Symptom Severity Domain (3 items) of the CASA-Q Questionnaire.
Measured: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Cough Impact
Cough Impact Domain (8 items) of the CASA-Q Questionnaire.
Measured: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
The difference between resistance at 5 Hertz (R5) and resistance at 20 Hertz (R20) (R5-20)
Measurement obtained from oscillometry.
Measured: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 202530 Jun 2026

First posted26 Sep 2024
Study start22 May 2025
Primary completion30 Jun 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06614959
Sponsor's protocol ID: 2025-10838
Other IDs: 2025
Status last verified: May 2025
First submitted: 24 Sep 2024
Last updated: 24 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06614959
Acronym / sponsor ID: 2025-10838
Conditions: COPD
Keywords: COPD, OPEP, Chronic Bronchitis, Disease Impact, Reactance, CASA-Q Questionnaire, Oscillometry
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
Collaborators: Trudell Medical International
Study start: 22 May 2025 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 26 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Oscillatory Positive Expiratory Pressure (OPEP) therapy arm	Experimental	Device: Oscillatory Positive Expiratory Pressure (OPEP) TherapyParticipants will receive and use the smart OPEP device at least twice a day in the home environment for 4 consecutive weeks.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oscillatory Positive Expiratory Pressure (OPEP) TherapyThe 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.	Device	Oscillatory Positive Expiratory Pressure (OPEP) therapy arm

Primary outcome

Cough Impact Domain of the CASA-Q (co-primary outcome)
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
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.
Reactance at 5 Hertz (Hz) (co-primary outcome)
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
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.

10 secondary outcomes

COPD Assessment Test (CAT)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Resonant frequency (Fres)
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Sputum Symptom Severity
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Cough Symptom Severity
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
Cough Impact
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).
The difference between resistance at 5 Hertz (R5) and resistance at 20 Hertz (R20) (R5-20)
Time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Individual participant dataSharing planned: No. Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).

Related trials for COPD

Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

RI-MUHC/MUHC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cough Impact Domain of the CASA-Q (co-primary outcome) (time frame: Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06614959.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.