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

NCT00323986 | Terminated Phase 2

• 1 other identifier: 39/2004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Conditions

COPD; Tracheostomy

Keywords

COPD; tracheotomy; azithromycin; exacerbation; hospitalisation; exhaled breath condensate

Outcome Measures

Primary Outcomes (2)

• reduction of number of exacerbations

• reduction of number of hospitalisations

Secondary Outcomes (3)

• reduction of colony counts/eradication of bacteria on bronchial aspirates

• reduction of steroids and antibiotics use

• reduction of inflammatory cytokines in EBC

Interventions

azithromycin (drug) DRUG

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent

You may not qualify if:

• Allergy to macrolides Life expectancy \< 1 year

Sponsors & Collaborators

• University of Milan: lead
• Pfizer: collaborator

Study Sites (3)

Istituto Nazionale di riposo e cura per anziani (INRCA)

Casatenovo, 23880, Italy

Location

Istituto Malattie Respiratorie University of Milan

Milan, 20122, Italy

Location

University Hospital Trieste

Trieste, 34100, Italy

Location

Related Publications (1)

• 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. doi: 10.1016/j.pupt.2009.12.002. Epub 2009 Dec 16.

  PMID: 20025989 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Azithromycin; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Francesco Blasi, MD

  Istituto Malattie Respiratorie University of Milan Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: October 1, 2004
• Study Completion: April 1, 2006
• Last Updated: May 10, 2006

Record last verified: 2006-04

Locations

IT (3)