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

Johns Hopkins University50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

COPD Chronic Bronchitis Emphysema

Interventions

pneumatic vestDEVICE

placebo pneumatic vestOTHER

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.

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.

Time frame: 12 weeks

Secondary Outcomes

Quality of Life

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.

Time frame: Change from baseline to 12 weeks

Data from ClinicalTrials.gov

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