Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy
NCT ID: NCT00323986
Last Updated: 2006-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2004-10-31
2006-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Dott. E. Guffanti, IRCCS INRCA Casatenovo, Varese Italy
* Prof. F. Blasi, Università degli Studi di Milano, IRCCS Ospedale Maggiore Milan Italy
* Dott, M. Confalonieri, Ospedale Trieste, Italy Patients
We plan to enrol 30 patients :
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
Exhaled breath condensate (EBC) The breath condensate samples is collected using a specially designed condensing chamber (Ecoscreen; Jaeger, Hoechberg, Germany). The exhaled air entered and left the chamber though one-way inlet and outlet valves, thus keeping the chamber closed. The subjects wear noseclips and breathed tidally through a mouthpiece connected to the condenser for ten minutes. Approximately 1 ml of the sampled material is transferred to 2-ml plastic tube and stored at -70°C.
Interleukin-6 assay Interleukin-6 concentrations in the breath condensate will be measured using a specific enzyme immunoassay kit (EIA) (Cayman Chemical, Ann Arbor, USA). The assay is directly validated by means of gas chromatography/mass spectrometry in order to obtain a high correlation (r=0.95) between known amounts of IL-6 and the concentration measured by the EIA. The detection limit of the assay was 1.5 pg/ml after a two-hour development period.
TNF alfa TNF-alfa serum levels will be measured by enzyme immunoassay (Cayman Chemical, Ann Arbor, USA)
Microbiology Quantitative culture of tracheal aspirate will be performed at steady state, every 3 months and at exacerbation. Molecular biology techniques for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Chlamydia pneumoniae and Mycoplasma pneumoniae identification will be also applied on the same specimens.
Timetable Enrolment: between January 2004 and December 2005 Visits : Every 3 months and on each exacerbation/hospitalization a visit will be performed. Every month a phone call will be performed.
Follow-up: 12 months. End of the study : July 2006
Visit
1. Visit 1. A complete history will be recorded. Inclusion and exclusion criteria will be checked. Informed consent will be collected and QoL questionnaire completed. Tracheal aspirate will be performed and divided into two aliquots : one for the local microbiology lab for quantitative cultures, and one for central lab for bacterial detection by PCR (stored at -80°C). Exhaled breath samples will be obtained.
2. Follow-up visits. Every 3 months the patients will be recalled at the center and all Visit 1 procedures will be repeated. Number of exacerbations/hospitalisation will be recorded and QoL questionnaire completed.
3. Exacerbation/hospitalisation visit. In presence of symptoms deterioration patients will be instructed to contact the center for a visit. All Visit 1 procedures will be repeated.
4. End of the study visit. At the end of the 12 month follow-up all Visit 1 procedures will be repeated. Number of exacerbations/hospitalisation will be recorded and QoL questionnaire completed.
Treatment Patients will be randomised to receive usual care or usual care + Azithromycin 500 mg o.d. three day-a-week (Monday, Tuesday, Wednesday) for 6 months.
Outcome measures
* reduction of inflammatory cytokines in EBC
* reduction of colony counts/eradication of bacteria on bronchial aspirates
* reduction of number of exacerbations/hospitalisations
* reduction of steroids and antibiotics use
* Quality of life
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
azithromycin (drug)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
45 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
University of Milan
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Blasi, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Malattie Respiratorie University of Milan Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istituto Nazionale di riposo e cura per anziani (INRCA)
Casatenovo, , Italy
Istituto Malattie Respiratorie University of Milan
Milan, , Italy
University Hospital Trieste
Trieste, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
39/2004
Identifier Type: -
Identifier Source: org_study_id