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Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.


- candidate number10398
- NTR NumberNTR3090
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2011
- Secondary IDs37727 ABR
- Public TitleSafety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.
- Scientific TitleSafety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.
- ACRONYMSTONAC
- hypothesisNot applicable: Phase 1 study --> Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD.
- Healt Condition(s) or Problem(s) studiedCOPD
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 3-okt-2011
- planned closingdate3-okt-2012
- Target number of participants8
- InterventionsThe included patients will be given amoxicillin clavulanic acid by inhalation in four dosing steps.
- Primary outcomeTo investigate the safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.
- Secondary outcomeTo investigate dose exposure data as determined by sputum and serum concentrations of amoxicillin.
- TimepointsA 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P.D.L.P.M. Valk, van der
- CONTACT for SCIENTIFIC QUERIESDr. P.D.L.P.M. Valk, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-sep-2011 - 18-okt-2011


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