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Sponsors and Collaborators: |
Johns Hopkins University Centers for Medicare and Medicaid Services Hill-Rom |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00181207 |
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.
Condition | Intervention |
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COPD Chronic Bronchitis Emphysema |
Device: pneumatic vest |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 50 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | January 2006 |
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.
Ages Eligible for Study: | 45 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Akasha Grant | 410-550-2707 | agrant10@jhmi.edu |
Contact: Kathy Thompson, RN, MSN | 410-550-2593 | kthomps1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Asthma and Allergy Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Akasha Grant 410-550-2707 agrant10@jhmi.edu | |
Contact: Kathy Thompson, RN,MSN 410-550-2593 kthomps1@jhmi.edu | |
Principal Investigator: Gregory B Diette, M.D.,M.H.S. |
Principal Investigator: | Gregory B Diette, M.D.,M.H.S | Johns Hopkins Medicine |
Study ID Numbers: | NA_000202, 18-P-92858/3-01 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00181207 |
Health Authority: | United States: Institutional Review Board |
COPD |
Pulmonary Emphysema Emphysema Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections |
Respiratory Tract Diseases Bronchial Diseases Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |
Pathologic Processes |