COPD
Conditions
Interventions
Participating patients will receive treatment by inhalation of nebulized
amoxicillin clavulanic acid in four dosing steps
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: dose exposure data as determined by sputum and serum concentrations of amoxicillin | — |
Countries
Netherlands
Outcome results
None listed