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Airway Clearance for Prevention of COPD Exacerbation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
Hill-Rom
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181207
First received: September 13, 2005
Last updated: March 29, 2012
Last verified: June 2011
History of Changes
  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 Phase
COPD
Chronic Bronchitis
Emphysema
 Device: pneumatic vest
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

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: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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

Locations
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
Hill-Rom
Investigators
Principal Investigator: Gregory B Diette, M.D.,M.H.S Johns Hopkins Medicine
  More Information

No publications provided

Responsible Party: Teresa Concordia, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181207     History of Changes
Other Study ID Numbers: NA_000202, 18-P-92858/3-01
Study First Received: September 13, 2005
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
COPD

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

ClinicalTrials.gov processed this record on June 18, 2013