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

Phase 4

Completed

• Conditions: Chronic Bronchitis; COPD; Emphysema
• Interventions: Device: pneumatic vest; Other: placebo pneumatic vest

• Registration Number: NCT00181207
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Results First Submitted: 2017-04-17
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-08
• Last Update Submitted: 2018-02-08
• Results First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	pneumatic vest	Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks
Sham	placebo pneumatic vest	Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating.

Primary Outcome Measures

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

Name	Time	Method
Quality of Life	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.

Trial Locations

Locations (1)

Johns Hopkins Asthma and Allergy Center; 🇺🇸 Baltimore, Maryland, United States