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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT00132860
• Study type: Interventional
• Source: Odense University Hospital
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2001
• Completion date: December 2007