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

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin

Criteria

Inclusion Criteria:

• Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.

• Current or ex-smoker

• Postbronchodilator FEV1 < 60% in stable condition (> 4 weeks after hospitalisation)

• < 300 ml bronchodilator reversibility in FEV1

Exclusion Criteria:

• Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).

• Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.

• Patients with pulmonary malignancy

• Patients with other pulmonary diseases than COLD.

• Patients with immunodeficiency. However, COLD patients treated with steroids can be included.

• Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.

• Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).

• Patients with known allergy or intolerance to azithromycin

• Pregnant or breastfeeding women

• Manifest heart, liver or renal insufficiency

• Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.