None listed
Conditions
Interventions
Intervention group:
Prednisolon 30 mg for 7 days, Antibiotics (Amoxicillin/clavulanic acid three times daily for 7 days) and a Body Area Network for monitoring of health status
Control group:
Prednisolon 30 mg for 7 days, Placebo of Amoxicillin/clavulanic acid (three times daily for 7 days) and a Body Area Network for monitoring of health status.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of the outpatient clinic of the Medical Spectrum Twente; 2. Age between 40 and 75; 3. A clinical diagnosis of COPD as defined by the GOLD-criteria; 4. A signed and dated written informed consent from the subject prior to study participation; 5. Patients with COPD presenting one or two of the following characteristics: a positive Gram’s stain of the sputum, a clinical relevant decrease of lung function, defined as a decrease in FEV1 of 200 ml or more and 12 % or more from baseline value, or two or more exacerbations in the previous year; 6. Present with signs and symptoms of an exacerbation at the outpatient clinic; 7. Current smoker or ex-smoker; 8. Able to understand, read and write Dutch.
Exclusion criteria
Exclusion criteria: 1. Serious other disease with a low survival rate; 2. Clinical symptoms (e.g. temperature > 38,5 oC), indicating pneumonia and a thorax X-ray positive for pneumonia; 3. Another disease, which influences bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoïdosis, pulmonary embolism, rib fracture, pneumonia and bronchial carcinoma); 4. Severe psychiatric illness; * Uncontrolled diabetes mellitus; 5. Need for regular oxygen therapy; 6. Maintenance therapy with antibiotics; 7. Subject with a known hypersensitivity to amoxicillin / clavulanic acid (Augmentin®); 8. Use of antibiotic 4 weeks before study entry; 9. Use of prednisolon (except for a maintenance ration) 4 weeks before study entry; 10. An exacerbation less than 4 weeks before study entry; 11. alpha1-antitrypsine deficiency; 12. Former participation in the ABC-trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF); 2. Relapse rate. A relapse is defined as an exacerbation that resolves due to the blinded treatment but re-occurs within 28 days of the treated exacerbation; 3. Cost-effectiveness of treatment with antibiotics; 4. Use of rescue-medication, recorded in the symptom diary; 5. Quality of life, measured by the Chronic Respiratory Questionnaire and the COPD Chronic Questionnaire. | — |
Contacts
Public ContactJ. Palen, van der
Medisch Spectrum Twente, P.O. Box 50000
Outcome results
None listed