NCT00132860

Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (planned)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	azithromycin

Timeline

• Start date: 2001-05-01
• Completion: 2007-12-01
• First posted: 2005-08-22
• Last updated: 2005-10-19

Locations

1 site across 1 country: Denmark