Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Show Detailed Description


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on October 21, 2016