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

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

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.

Study Overview

• Status: Completed
• Conditions: Emphysema; COPD; Chronic Bronchitis
• Intervention / Treatment: Device: pneumatic vest; Other: placebo pneumatic vest

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Asthma and Allergy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Centers for Medicare and Medicaid Services; Hill-Rom
• Investigators: Principal Investigator: Gregory B Diette, M.D.,M.H.S, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: NA_000202; 18-P-92858/3-01