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NCT Number: NCT06614959

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

    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.

  2. 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).

    Sputum Impact domain (6 items) of the CASA-Q Questionnaire.

  3. 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).

    Measurement obtained from intra-breath oscillometry.

  4. 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).

    Measurement obtained from intra-breath oscillometry.

  5. 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).

    Measurement obtained from oscillometry.

  6. 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).

    Measurement obtained from oscillometry.

  7. 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).

    Sputum Symptom Severity Domain (3 items) of the CASA-Q Questionnaire

    .

  8. 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 Symptom Severity Domain (3 items) of the CASA-Q Questionnaire.

  9. 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).

    Cough Impact Domain (8 items) of the CASA-Q Questionnaire.

  10. 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).

    Measurement obtained from oscillometry.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Trudell Medical International

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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