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| ID | Type | Description | Link |
|---|---|---|---|
| 18-P-92858/3-01 |
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| Name | Class |
|---|---|
| Centers for Medicare and Medicaid Services | FED |
| Hill-Rom | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks |
|
| Sham | Placebo Comparator | Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pneumatic vest | Device |
| ||
| placebo pneumatic vest |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory B Diette, M.D.,M.H.S | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham | Placebo Comparator: Sham Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating |
| FG001 | Active | Experimental: Active Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham | received sham version of VEST |
| BG001 | Active | received functional version of VEST |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Inter-Quartile Range | exacerbations per 12 weeks | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham | received sham version of VEST | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Diette | Johns Hopkins University | 410-955-3497 | gdiette@jhmi.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Inter-Quartile Range | units on a scale | Change from baseline to 12 weeks |
|
|
|
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Active | received functional version of VEST | 0 | 26 | 0 | 26 | 0 | 26 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |