Azithromycin for Acute Exacerbations Requiring Hospitalization

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wim Janssens
• Collaborator: Agentschap voor Innovatie door Wetenschap en Technologie
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)

• Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)

• Current hospitalization for potential infectious AECOPD treated with standard therapy

• History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken

• ECG at admission

Exclusion Criteria:

• Mechanical or non-invasive ventilation at moment of randomization (D1)

• Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)

• History of life-threatening arrhythmias

• Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug

• Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission

• Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)

• Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ < 0.5 mmol/L)

• Chronic systemic steroids (> 4 mg methylprednisolone /day for ≥ 2 months)

• Actual use of macrolides for at least 2 weeks

• Allergy to macrolides

• Active cancer treatment

• Life expectancy < 3 months

• Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment