Status:
COMPLETED
High Frequency Chest Wall Oscillation in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
East and North Hertfordshire NHS Trust
Collaborating Sponsors:
Electromed, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
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 infe...
Detailed Description
1.1 Background Chronic obstructive pulmonary disease (COPD) is a major health problem across the world and its medical, societal and economic impacts continue to grow. COPD is characterized by chroni...
Eligibility Criteria
Inclusion
- 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)
- Age 40-85 years
- Mucus hypersecretion ( \> 25 ml/72 h collection)
Exclusion
- Chest wall deformity (i.e., kyphoscoliosis, Rib fractures)
- Severe osteoporosis
- Haemoptysis within the last 3 months
- Thoracic or abdominal surgery within 3 months
- Respiratory failure on non-invasive ventilator therapy
- Tracheostomy or neck deformities
- Neuro-muscular dysfunction or disability (i.e., Paralysis due to cerebrovascular disease) which may make it impossible to use the device safely
- Congestive heart failure (decompensated)
- Any other mucolytic therapy
- Significant hiatus hernia or gastro-esophageal reflux disease
- Recent myocardial infarction or unstable angina
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00863616
Start Date
August 1 2006
End Date
October 1 2007
Last Update
March 18 2009
Active Locations (1)
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1
East & North Herts NHS Trust
Stevenage, Herts, United Kingdom, SG1 4AB