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| Name | Class |
|---|---|
| Trudell Medical International | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan A. Ross, MD, MSc (Physiol), MSc (Epi) | Contact | (514) 843-1465 | bryan.ross@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Bryan A. Ross, MD, MSc (Physiol), MSc (Epi) | RI-MUHC/MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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).
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Sputum Impact |
Sputum Impact domain (6 items) of the CASA-Q Questionnaire. |
| 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. | 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. | 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. | 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. | 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 . | 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. | 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. | 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. | Baseline (within 7 days preceding the 4-week intervention period) and End-of-Study (within 7 days following the 4-week intervention period). |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |