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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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:

MedlinePlus related topics: Antibiotics COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:

reduction of number of exacerbations
reduction of number of hospitalisations

Secondary Outcome Measures:

reduction of colony counts/eradication of bacteria on bronchial aspirates
reduction of steroids and antibiotics use
reduction of inflammatory cytokines in EBC

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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 by University of Milan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blasi F, Bonardi D, Aliberti S, Tarsia P, Confalonieri M, Amir O, Carone M, Di Marco F, Centanni S, Guffanti E. Long-term azithromycin use in patients with chronic obstructive pulmonary disease and tracheostomy. Pulm Pharmacol Ther. 2010 Jun;23(3):200-7. Epub 2009 Dec 16.

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

Keywords provided by University of Milan:

COPD
tracheotomy
azithromycin

exacerbation
hospitalisation
exhaled breath condensate

Additional relevant MeSH terms:

Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Lung Diseases, Obstructive
Respiratory Tract Diseases
Infection

Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012