Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.
Recruiting
- Conditions
- COPD
- Registration Number
- NL-OMON26217
- Lead Sponsor
- Medisch Spectrum TwenteP.O.Box 50.0007500 KA EnschedeThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
1. A clinical diagnosis of stable COPD, as defined by GOLD criteria;
2. Able to produce sputum;
Exclusion Criteria
1. Exacerbation or use of prednisolone or antibiotics 4 weeks related to an exacerbation prior to enrolment;
2. Current pneumonia, defined as an acute respiratory tract illness associated with radiographic shadowing on a chest radiograph which was neither pre-existing nor of any other cause;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate 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 To investigate dose exposure data as determined by sputum and serum concentrations of amoxicillin.