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Airway Clearance for Prevention of COPD Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
COPD Chronic Bronchitis Emphysema Device: pneumatic vest Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2004
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. The primary outcome measure is the rate of exacerbations as defined using the Winnipeg criteria.

Secondary Outcome Measures :
  1. Weekly recall diary for healthcare use, new medication use, change of medication use, respiratory symptoms and days of activity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Johns Hopkins University
Centers for Medicare and Medicaid Services
Principal Investigator: Gregory B Diette, M.D.,M.H.S Johns Hopkins University
More Information

Responsible Party: Teresa Concordia, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181207     History of Changes
Other Study ID Numbers: NA_000202
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: June 2011

Keywords provided by Johns Hopkins University:

Additional relevant MeSH terms:
Bronchitis, Chronic
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive