Airway Clearance for Prevention of COPD Exacerbation - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Centers for Medicare and Medicaid Services Hill-Rom
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181207

Purpose

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
COPD Chronic Bronchitis Emphysema	Device: pneumatic vest

MedlinePlus related topics: Bronchitis Emphysema

U.S. FDA Resources

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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	May 2004
Estimated Study Completion Date:	January 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181207

Contacts

Contact: Akasha Grant	410-550-2707	agrant10@jhmi.edu
Contact: Kathy Thompson, RN, MSN	410-550-2593	kthomps1@jhmi.edu

Locations

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.

Sponsors and Collaborators

Johns Hopkins University

Centers for Medicare and Medicaid Services

Hill-Rom

Investigators

Principal Investigator:

Gregory B Diette, M.D.,M.H.S

Johns Hopkins Medicine

More Information

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

Keywords provided by Johns Hopkins University:

COPD

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009