Not applicable: Phase II study --> Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
ID
Bron
Verkorte titel
Aandoening
Acute exacerbation of COPD
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Not applicable: Phase II study --> Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
Onderzoeksopzet
Nebulizations will take place during hospitalization with a maximum of 7 days. Nebulization will take place two times a day. After every nebulization the patient will fill in a short questionnaire. Before and after the first nebulization spirometry will take place. Sputum will be collected before the second inhalation, at three times at day three and before the last inhalation. A blood sample will be taken at day 3.
Onderzoeksproduct en/of interventie
The included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. A clinical diagnosis of COPD, as defined by GOLD criteria;
2. Hospitalized for an acute exacerbation of COPD;
3. Admitted to ward A4 or C4;
4. Able to produce sputum;
5. Age 40 years or over;
6. Current or former smoker.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Current pneumonia, defined as an acute respiratory tract illness associated with radiographic shadowing on a X-ray or CT-scan of the chest which was neither pre-existing nor of any other cause;
2. Allergy for penicillin, amoxicillin or clavulanic acid. (patients must have been treated with amoxicillin before without a report of allergic reactions);
3. History of severe AECOPD requiring mechanical ventilation;
4. Recently diagnosed or unresolved lung malignancy;
5. Impaired renal function (Creatinine Clearance < 20 ml/min);
6. Congestive Heart Failure (NYHA III-IV).
During the trial the patient cannot be treated with systemic amoxicillin clavulanic acid.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3817 |
NTR-old | NTR3983 |
CCMO | NL44131.044.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |