Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Self-Administered High Frequency Chest Wall Oscillation Technique for Mucus Clearance in COPD: An Exploratory Pilot Project Using the SMARTVEST Device
Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus
production and breathlessness as cardinal features. The excess mucus production often leads
to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may
have an impact on improving symptoms, exercise tolerance, quality of life and reduce
exacerbations.
High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall
delivered from a pump through a close fitting inflatable vest. This technique has been shown
to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot
study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in
patients with advanced COPD.
Status | Completed |
Enrollment | 32 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. COPD; patients defined by a history of cough, breathlessness and/ mucus/sputum production with lung function showing FEV1/FVC <70% and FEV1<80% predicted and < 20% reversibility from baseline on administration of nebulised b2-agonist (Salbutamol 5mg) 2. Age 40-85 years 3. Mucus hypersecretion ( > 25 ml/72 h collection) Exclusion Criteria: 1. Chest wall deformity (i.e., kyphoscoliosis, Rib fractures) 2. Severe osteoporosis 3. Haemoptysis within the last 3 months 4. Thoracic or abdominal surgery within 3 months 5. Respiratory failure on non-invasive ventilator therapy 6. Tracheostomy or neck deformities 7. Neuro-muscular dysfunction or disability (i.e., Paralysis due to cerebrovascular disease) which may make it impossible to use the device safely 8. Congestive heart failure (decompensated) 9. Any other mucolytic therapy 10. Significant hiatus hernia or gastro-esophageal reflux disease 11. Recent myocardial infarction or unstable angina |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | East & North Herts NHS Trust | Stevenage | Herts |
Lead Sponsor | Collaborator |
---|---|
East and North Hertfordshire NHS Trust | Electromed, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health related quality of life (St George's Respiratory Questionnaire) | 3 months | No | |
Secondary | Exercise tolerance (Endurance Shuttle Walk Time achieved) | 3 months | No |
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