NCT02135354

Azithromycin for Acute Exacerbations Requiring Hospitalization

Belgian Trial With Azithromycin During Acute COPD Exacerbations

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Wim Janssens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Azithromycin	* From day 1 up to and including day 3: 500 mg azithromycin PO once a day * From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days
DRUG	Placebo	* From day 1 up to and including day 3: 500 mg placebo PO once a day * From day 4 up to and including day 90: 250 mg placebo PO once every 2 days

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-10-01
• Completion: 2018-04-01
• First posted: 2014-05-09
• Last updated: 2018-09-05

Locations

20 sites across 1 country: Belgium