Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Aims of the study

• to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients

• to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.

• to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire

• to evaluate the rate of chronic colonization with atypical pathogens

• to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Collaborator: Pfizer
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Age > 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent

Exclusion Criteria:

• Allergy to macrolides Life expectancy < 1 year