Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.
Completed
- Conditions
- COPD10006436
- Registration Number
- NL-OMON35569
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
• • A clinical diagnosis of stable COPD, as defined by GOLD criteria;• Able to produce sputum;• Age 40 years or over ;• Current or former smoker.
Exclusion Criteria
• Exacerbation or use of prednisolone or antibiotics related to an exacerbation 4 weeks prior to enrolment.;• 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.;• Allergy for penicillin, amoxicillin or clavulanic acid.;• Respiratory insufficiency and hypercapnia measured by arterial blood gas analyses.;• FEV1 postbronchodilator< 1.2 l.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary: safety and tolerability of inhalation of nebulized amoxicillin<br /><br>clavulanic acid, as determined by spirometry and adverse effects monitoring. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: dose exposure data as determined by sputum and serum concentrations<br /><br>of amoxicillin</p><br>