No registrations found.
ID
Source
Brief title
Health condition
COPD
Sponsors and support
P.O.Box 50.000
7500 KA Enschede
The Netherlands
Onderzoeksbureau longgeneeskunde
Medisch Spectrum Twente
P.O.Box 50.000
7500 KA Enschede
The Netherlands
Intervention
Outcome measures
Primary outcome
To investigate the safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.
Secondary outcome
To investigate dose exposure data as determined by sputum and serum concentrations of amoxicillin.
Background summary
N/A
Study objective
Not applicable: Phase 1 study --> Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.
Study design
A 3 hour follow up will take place. After 3 hours a blood sample will be obtained and coughed up sputum is collected throughout the 3 hours.
Intervention
The included patients will be given amoxicillin clavulanic acid by inhalation in four dosing steps.
Department of Pulmonology<br>
PO Box 50.000
P.D.L.P.M. Valk, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872610
P.vanderValk@mst.nl
Department of Pulmonology<br>
PO Box 50.000
P.D.L.P.M. Valk, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872610
P.vanderValk@mst.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2943 |
| NTR-old | NTR3090 |
| Other | ABR : 37727 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |