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

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ClinicalTrials.gov Identifier: NCT00323986
Recruitment Status : Terminated
First Posted : May 10, 2006
Last Update Posted : May 10, 2006
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Milan

Brief Summary:

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 or disease Intervention/treatment Phase
COPD Tracheostomy Drug: azithromycin (drug) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. reduction of number of exacerbations
  2. reduction of number of hospitalisations

Secondary Outcome Measures :
  1. reduction of colony counts/eradication of bacteria on bronchial aspirates
  2. reduction of steroids and antibiotics use
  3. reduction of inflammatory cytokines in EBC


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: May 10, 2006
Last Verified: April 2006

Keywords provided by University of Milan:
COPD
tracheotomy
azithromycin
exacerbation
hospitalisation
exhaled breath condensate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases