Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy - Full Text View

Sponsor:	University of Milan
Collaborator:	Pfizer
Information provided by:	University of Milan
ClinicalTrials.gov Identifier:	NCT00323986

Purpose

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

Condition	Intervention	Phase
COPD Tracheostomy	Drug: azithromycin (drug)	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence

Resource links provided by NLM:

Drug Information available for: Azithromycin

Further study details as provided by University of Milan:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	30
Study Start Date:	October 2004
Estimated Study Completion Date:	April 2006

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323986

Locations

Italy
Istituto Nazionale di riposo e cura per anziani (INRCA)
Casatenovo, Italy, 23880
Istituto Malattie Respiratorie University of Milan
Milan, Italy, 20122
University Hospital Trieste
trieste, Italy, 34100

Sponsors and Collaborators

University of Milan

Pfizer

Investigators

Principal Investigator:

Francesco Blasi, MD

Istituto Malattie Respiratorie University of Milan Italy

More Information

No publications provided

Study ID Numbers:	39/2004
Study First Received:	May 8, 2006
Last Updated:	May 8, 2006
ClinicalTrials.gov Identifier:	NCT00323986 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by University of Milan:

COPD
tracheotomy
azithromycin

exacerbation
hospitalisation
exhaled breath condensate

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Azithromycin
Lung Diseases
Pharmacologic Actions
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 04, 2010