Azithromycine during and after the acute hospital admission for acute exacerbation of chronic obstructive pulmonary disease

Phase 1

• Conditions: Acute COPD exacerbations with hospitalisation.; MedDRA version: 18.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855; MedDRA version: 18.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-004420-11-BE
• Lead Sponsor: KU Leuven - UZ Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-13
• Study Completion: 2018-01-19
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 301

Inclusion Criteria

1/ Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
2/ Smoking history (= 10 pack-years)
3/ Current hospitalization for potential infectious AECOPD treated with standard therapy
4/ History of at least one exacerbation during the last year for which systemic steroids and/or antibiotics were taken
5/ ECG at admission
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1/ Mechanical or non-invasive ventilation at moment of randomisation (D1)
2/ Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)
3/ History of life-threatening arrhythmias
4/ Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before of start study
5/ Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
6/ Drugs with high risk for long QT interval and torsade de pointes
(amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides).
7/ Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ <0.5 mmol/L)
8/ Chronic systemic steroids (> 4 mg methylprednisolone /day for = 2 months)
9/ Actual use of macrolides for at least 2 weeks
10/ Allergy to macrolides
11/ Active cancer treatment
12/ Life expectancy < 3 months
13/ Pregnant or breast-feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first objective is to proof the effectiveness of azithromycin on top of standard therapy in the acute treatment of COPD exacerbations which require hospitalization. ;Secondary Objective: A second objective is to proof and improve safety without losing effectiveness by reducing dose and duration of a current everlasting treatment. ;Primary end point(s): The primary endpoint is time to treatment failure.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after 3 months, which is also the day that all study medication will be stopped.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints of the study will include number of treatment failures, time to new exacerbation, number of exacerbations, total days of hospitalization, total days of intensive care, total days of antibiotics, total dose of systemic steroids but also FEV1 and self-administered symptom or quality of life scores (EQ5D, CCQ, CAT, SSQ5). ;Timepoint(s) of evaluation of this end point: The secondary endpoints of the study will be evaluated at discharge, after 3 months and 9 months.