The purpose of the study is to investigate in patients with moderate to severe Chronic Obstructive Lung Disease, whether intermittent antibiotic treatment leads to:

• Slower rate of decline in FEV1
• Reduction in the frequency and severity of exacerbations
• Fewer hospital admission for COPD
• Lower mortality
• Improved quality of life as compared to a group of placebo treated patients.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: azithromycin	Phase IV

Further Study Details: 

Primary Outcomes: Primary end-point; - change in postbronchodilator FEV1
Secondary Outcomes: - number of hospital admissions and number of hospitaldays; - mortality; - quality of life; - use of medication; - prevalence of respiratory pathogens; - prevalence of macrolide resistance; - inflammatory parameters
Expected Total Enrollment:  800

Studypopulation: 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, totally 800 patients

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

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
• PostbronkodilatorFEV1 < 60% in stable condition (> 4 weeks after hospitalisation)
• <300 ml bronchodilatorreversibility in FEV1

Exclusion Criteria:

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

• Patients with known other respiratory tract infection, e.g. tuberkulosis or aspergillo sis, in whom in 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 infection such a alfa-1-antiptryp sin deficiency, cystic fibrosis or primary ciliary dyskinesia.
• Patients receiving longterm antibiotic treatment ( e.g. recurent cystitis).
• Patients with known allergy or intolerance to azithromycin
• Pregnant or breastfeeding women
• Manifest heart, liver or renalinsufficiency
• Patients that for reasons not stated above are unlikely to be able to participate in a study period of 3 years.

Denmark
      Odense University Hospital, Odense,  5000 C,  Denmark

Study chairs or principal investigators

Svend S Pedersen,  Principal Investigator,  Odense University Hospital   

Study ID Numbers:  ProToCOL
Last Updated:  August 19, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00132860
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-13