COPD
Conditions
Interventions
The included patients will be given amoxicillin clavulanic acid by inhalation in four dosing steps.
Sponsors
Medisch Spectrum Twente
P.O.Box 50.000
7500 KA Enschede
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. A clinical diagnosis of stable COPD, as defined by GOLD criteria; 2. Able to produce sputum; 3. Age 40 years or over; 4. Current or former smoker.
Exclusion criteria
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; 3. Allergy for penicillin, amoxicillin or clavulanic acid; 4. Respiratory insufficiency and hypercapnia measured by arterial blood gas analyses; 5. FEV1 postbronchodilator < 1.2 l.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate dose exposure data as determined by sputum and serum concentrations of amoxicillin. | — |
Contacts
Public ContactP.D.L.P.M. Valk, van der
Medisch Spectrum Twente Hospital Department of Pulmonology PO Box 50.000
Outcome results
None listed