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

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Chronic Bronchitis; Emphysema; COPD

Treatments: Other: placebo pneumatic vest; Device: pneumatic vest

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00181207

NA_000202

18-P-92858/3-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks

Treatment:

Device: pneumatic vest

Sham

Placebo Comparator group

Description:

Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating.

Treatment:

Other: placebo pneumatic vest