Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
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|ClinicalTrials.gov Identifier: NCT00181207|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|COPD Chronic Bronchitis Emphysema||Device: pneumatic vest Other: placebo 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)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel 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|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2007|
Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks
Device: pneumatic vest
Placebo Comparator: Sham
Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating.
Other: placebo pneumatic vest
- The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria. [ Time Frame: 12 weeks ]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.
- Quality of Life [ Time Frame: Change from baseline to 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|