Airway Clearance for Prevention of COPD Exacerbation
|ClinicalTrials.gov Identifier: NCT00181207|
Recruitment Status : Unknown
Verified June 2011 by Johns Hopkins University.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : March 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|COPD Chronic Bronchitis Emphysema||Device: pneumatic vest||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||May 2004|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||December 2012|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University|