Status:
TERMINATED
Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy
Lead Sponsor:
University of Milan
Collaborating Sponsors:
Pfizer
Conditions:
COPD
Tracheostomy
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
Brief 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 aer...
Detailed Description
Methods. Study Design Prospective, randomised, multicentre study. Centers * Dott. E. Guffanti, IRCCS INRCA Casatenovo, Varese Italy * Prof. F. Blasi, Università degli Studi di Milano, IRCCS Ospedale ...
Eligibility Criteria
Inclusion
- Age \> 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent
Exclusion
- Allergy to macrolides Life expectancy \< 1 year
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00323986
Start Date
October 1 2004
End Date
April 1 2006
Last Update
May 10 2006
Active Locations (3)
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1
Istituto Nazionale di riposo e cura per anziani (INRCA)
Casatenovo, Italy, 23880
2
Istituto Malattie Respiratorie University of Milan
Milan, Italy, 20122
3
University Hospital Trieste
Trieste, Italy, 34100