Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Study Overview
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Brief Summary
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The purpose of this study is to show that one form of mechanical airway clearance techniques, High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish exacerbations of COPD which will improve respiratory health status.

Detailed Description
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Approximately 60 to 70% of people with COPD have chronic cough and phlegm, the cardinal symptoms of chronic bronchitis or chronic mucus hypersecretion (CMH). Once thought to be a relatively benign condition, recent evidence shows that CMH in patients with established COPD is associated with greater decline in lung function, more frequent respiratory infections, more frequent exacerbations and increased mortality.Using mechanical airway clearance techniques (The Vest) will diminish exacerbations of COPD which will improve respiratory health status. Comparison: Patients randomly assigned to the vest will have fewer exacerbations of COPD,better quality of life and less health care use compared to patients assigned to a sham vest.

Official Title
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A Randomized, Sham-controlled, Double-blinded Pilot Study to Assess the Effects of High Frequency Chest Wall Oscillation (HFCWO) Therapy in Patients With Chronic Bronchitis

Conditions
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Chronic Bronchitis, COPD, Emphysema

Intervention / Treatment
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* Device: pneumatic vest
* Other: placebo pneumatic vest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician Diagnosis of COPD,chronic bronchitis and/or emphysema Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) < or = 70% FEV1 < or = 65% Current or former smoker > or = 20 pack years History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription Exclusion Criteria: Other lung diseases Co-morbid illnesses such as cancer, liver disease, cardiomyopathy Recent chest wall or abdominal trauma or surgery that would preclude using the vest

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks | Device: pneumatic vest<br> <br> |
| Placebo Comparator: Sham<br>Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating. | Other: placebo pneumatic vest<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria. | count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | The SF-36 is used to measure health related quality of life. It assesses eight health concepts and provides physical and mental health summary scores. The summary scores range from 0 to 100, with 0 representing the worst and 100 the best quality of life. | Change from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD