Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Belgian Trial With Azithromycin During Acute COPD Exacerbations
This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled
multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of
azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission.
Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent
risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment
and by restricting the treatment to acute periods with highest risk for treatment failure,
benefits may counterbalance potential side effects, which may result in a new treatment
strategy for these acute events.
The present study is designed by the services of respiratory medicine of the Leuven and Ghent
University hospitals but will run in total in 17 different large hospitals in Belgium, of
which 12 are located in Flanders.
In this 9 month, randomized, placebo-controlled, parallel-group, multicenter intervention trial, 500 patients will be randomly assigned (1:1 ratio) to receive either azithromycin or placebo on top of standard therapy in the acute treatment of COPD exacerbations requiring hospitalization. The study drug (azithromycin or placebo) will be initiated and uploaded within 48 hours after hospital admission (500mg once a day for 3 days) and subsequently administered for a prolonged period of 3 months at a lower maintenance dose (250mg every 2 days). An additional follow-up period of 6 months without study drug will be foreseen to study relapse after study drug withdrawal. ;
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