Chronic Bronchitis, COPD, Emphysema
Conditions
Keywords
COPD
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.
Interventions
DEVICEpneumatic vest
OTHERplacebo pneumatic vest
Sponsors
Centers for Medicare and Medicaid Services
Hill-Rom
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham received sham version of VEST | 24 |
| Active received functional version of VEST | 26 |
| Total | 50 |
Baseline characteristics
| Characteristic | Active | Total | Sham |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 7.4 | 62.7 years STANDARD_DEVIATION 8.1 | 62.8 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 40 Participants | 17 Participants |
| Region of Enrollment United States | 26 Participants | 50 Participants | 24 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 32 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sham | The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria. | 5.5 exacerbations per 12 weeks |
| Active | The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria. | 4 exacerbations per 12 weeks |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sham | Quality of Life | 5 units on a scale |
| Active | Quality of Life | 0 units on a scale |