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

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00323986
First received: May 8, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  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:

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):

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 21, 2013