Airway Clearance for Prevention of COPD Exacerbation
Recruitment status was: Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|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|
- The primary outcome measure is the rate of exacerbations as defined using the Winnipeg criteria.
- Weekly recall diary for healthcare use, new medication use, change of medication use, respiratory symptoms and days of activity
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181207
|United States, Maryland|
|Johns Hopkins Asthma and Allergy Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Gregory B Diette, M.D.,M.H.S||Johns Hopkins Medicine|