drugset / Trial / NCT00323986

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

NCT00323986

Phase 2 Terminated 30 enrolled University of Milan Pfizer · collab
RandomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2004-10
Primary completion
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 500 mg