This trial is active, not recruiting.

Conditions copd, chronic bronchitis, emphysema
Treatment pneumatic vest
Phase phase 4
Sponsor Johns Hopkins University
Collaborator Centers for Medicare and Medicaid Services
Start date May 2004
End date November 2012
Trial size 50 participants
Trial identifier NCT00181207, 18-P-92858/3-01, NA_000202


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention

Primary Outcomes

The primary outcome measure is the rate of exacerbations as defined using the Winnipeg criteria.
time frame:

Secondary Outcomes

Weekly recall diary for healthcare use, new medication use, change of medication use, respiratory symptoms and days of activity
time frame:

Eligibility Criteria

Male or female participants from 45 years up to 85 years old.

Inclusion Criteria: - Physician Diagnosis of COPD,chronic bronchitis and/or emphysema - FEV1/FVC < or = 70% - FEV1 < or = 65% - Current or former smoker > or = 20 pack years - History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, ED vist, antibiotic or steroid prescription Exclusion Criteria: - Other lung diseases - Co-morbid illnesses such as cancer, liver disease, cardiomyopathy - Recent chest wall or abdominal trauma or surgery that would preclude using the vest

Additional Information

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
Principal investigator Gregory B Diette, M.D.,M.H.S
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Johns Hopkins University.