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OpenTrials
Completed

NCT Number: NCT00181207

Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pneumatic vest

Device

placebo pneumatic vest

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Centers for Medicare and Medicaid Services
  • Hill-Rom

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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