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

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

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
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:

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

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 identifier: NCT00323986

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
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 Identifier (NCT Number): 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:
exhaled breath condensate

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Lung Diseases, Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 22, 2014