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What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Obstructive Pulmonary Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AzithromycinFrom 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:PlaceboFrom 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AzithromycinN = 250 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

PlaceboN = 250 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

Study Status

Terminated

Start Date: August 1, 2014

Completed Date: April 2018

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Time to clinical failure

Secondary Outcome: Number of clinical failures up to Day 90 (key secondary #1)

Study sponsors, principal investigator, and references

Principal Investigator: Wim Janssens, MD. PhD

Lead Sponsor: Wim Janssens

Collaborator: Agentschap voor Innovatie door Wetenschap en Technologie

More information:https://clinicaltrials.gov/show/NCT02135354