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Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (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. Identifier: NCT00181207
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Johns Hopkins University

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 Other: placebo 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel 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
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
Experimental: Active
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Physician Diagnosis of COPD,chronic bronchitis and/or emphysema
  • Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (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, Emergency Department (ED) visit, 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

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 identifier (NCT number): NCT00181207

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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
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Principal Investigator: Gregory B Diette, M.D.,M.H.S Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT00181207    
Other Study ID Numbers: NA_000202
First Posted: September 16, 2005    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: February 2018
Keywords provided by Johns Hopkins University:
Additional relevant MeSH terms:
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Bronchitis, Chronic
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections