The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to: * A slower rate of decline in forced expiratory volume in one second (FEV1); * A reduction in the frequency and severity of exacerbations; * Fewer hospital admissions for chronic obstructive pulmonary disease (COPD); * Lower mortality; * An improved quality of life as compared to a group of placebo treated patients.
Study Population: Patients with moderate to severe chronic obstructive lung disease. Trial Phase: IV Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial. Study Medicine: Azithromycin. Drug Administration: Oral. Drug Dose: 500 mg once daily for 3 days every month. Duration of Treatment: 3 years Number of Evaluable Patients: 200 per treatment arm Number of Included Patients: 400 per treatment arm, 800 patients in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
Odense University Hospital
Odense, Denmark
change in postbronchodilator FEV1
number of hospital admissions and number of hospital days
mortality
quality of life
use of medication
prevalence of respiratory pathogens
prevalence of macrolide resistance
inflammatory parameters
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