Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
- Conditions
- Acute exacerbation of COPD
- Registration Number
- NL-OMON21366
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
1. A clinical diagnosis of COPD, as defined by GOLD criteria;
2. Hospitalized for an acute exacerbation of COPD;
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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.
- Secondary Outcome Measures
Name Time Method Amoxicillin levels in sputum give information about the appropriateness of the given dose.