Acute exacerbation of COPD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A clinical diagnosis of COPD, as defined by GOLD criteria; 2. Hospitalized for an acute exacerbation of COPD; 3. Admitted to ward A4 or C4; 4. Able to produce sputum; 5. Age 40 years or over; 6. Current or former smoker.
Exclusion criteria
Exclusion criteria: 1. Current pneumonia, defined as an acute respiratory tract illness associated with radiographic shadowing on a X-ray or CT-scan of the chest which was neither pre-existing nor of any other cause; 2. Allergy for penicillin, amoxicillin or clavulanic acid. (patients must have been treated with amoxicillin before without a report of allergic reactions); 3. History of severe AECOPD requiring mechanical ventilation; 4. Recently diagnosed or unresolved lung malignancy; 5. Impaired renal function (Creatinine Clearance < 20 ml/min); 6. Congestive Heart Failure (NYHA III-IV). During the trial the patient cannot be treated with systemic amoxicillin clavulanic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Amoxicillin levels in sputum give information about the appropriateness of the given dose. | — |
Contacts
Medisch Spectrum Twente Hospital Department of Pulmonology PO Box 50.000