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Sponsored by: |
University of Milan |
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Information provided by: | University of Milan |
ClinicalTrials.gov Identifier: | NCT00524095 |
Bronchiectasis is a chronic pulmonary disease characterized by an irreversible dilatation of the bronchi. The current view of the pathogenesis of bronchiectasis considers initial colonization of the lower respiratory tract by different microorganisms as the first step leading to an inflammatory response characterized by neutrophil migration within the airways and secondary secretion of a variety of tissue-damaging oxidants and enzymes such as neutrophil elastase and myeloperoxidase. Persistence of microorganisms in the airways because of impairment in mucus clearance may lead to a vicious circle of events characterized by chronic bacterial colonization, persistent inflammatory reaction, and progressive tissue damage. The exact prevalence of bronchiectasis in COPD patients is not known. It would be important to assess the prevalence, the kind of bronchiectasis and the bacterial colonisation. These are all important features that can be related to the natural history of COPD and to the therapeutic management of patient with COPD and bronchiectasis. Recent data indicate that macrolide long-term treatment and inhaled steroids therapy are both associated with a reduced rate of exacerbation, bronchial colonization and inflammation The present study will address, on a relatively large number of patients, the prevalence of bronchiectasis in COPD subjects using a multislice CT scan technique applied in all the units and centrally analysed by Unit 2 and 4. This analysis will determine the presence and the morphology of bronchiectasis. Bacterial colonization and inflammatory parameters will be evaluated on blood and exhalate bronchial condensate. Concerning bacterial colonization molecular biology techniques (Qualitative PCR and quantitative real time PCR) will be applied. ELISPOT technique for the evaluation of specific immune response will be used.Electron and optical microscopy techniques will be applied on bronchial biopsy samples obtained in a subgroup of patients enrolled. During the second study year, a randomized trial on patients with bronchiectasis will be performed. Patients will be randomized to receive a macrolide or inhaled steroids or standard of care for 6 months with a follow-up of 6 months. All the inflammatory, microbiologic and functional parameters described above will be recorded. A clinical and functional evaluation will be applied looking to number of exacerbations, quality of life, respiratory function parameters.
Condition | Intervention | Phase |
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Bronchiectasis Pulmonary Disease Chronic Bronchitis |
Drug: azithromycin and fluticasone Drug: fluticasone and azithromycin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Bronchiectasis in COPD Patients : Role of Prophylaxis With Inhaled Steroids and Antibiotic on the Natural History of the Disease |
Estimated Enrollment: | 145 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
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1: No Intervention
standard of care
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2: Experimental
azithromycin 500 mg once a day three times a week for 6 months and then inhaled steroids (fluticasone 500 ug bid) for 6 months
|
Drug: azithromycin and fluticasone
azithromycin 500 mg once a day three times a week for 6 months and then inhaled steroids (fluticasone 500 ug bid) for 6 months
|
3: Experimental
inhaled steroids (fluticasone 500 ug bid) for 6 months and then azithromycin 500 mg once a day three times a week for 6 months
|
Drug: fluticasone and azithromycin
inhaled steroids (fluticasone 500 ug bid) for 6 months and then azithromycin 500 mg once a day three times a week for 6 months
|
Ages Eligible for Study: | 45 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francesco Blasi, MD | 3902503 ext 20621 | francesco.blasi@unimi.it |
Contact: Paolo Tarsia, MD | 39025503 ext 3785 | paolotarsia@policlinico.mi.it |
Italy | |
Istituto Malattie Respiratorie University of Milan | Recruiting |
Milan, Italy, 20122 | |
Contact: Francesco Blasi, MD 0250320623 ext 39 francesco.blasi@unimi.it | |
Contact: luigi allegra, MD 0250320621 ext 39 luigi.allegra@unimi.it | |
Principal Investigator: francesco blasi, MD | |
Sub-Investigator: Paolo Tarsia, MD | |
Sub-Investigator: Stefano Aliberti, MD | |
Dip. SCIENZE CLINICHE Università degli Studi di PARMA | Recruiting |
Parma, Italy, 43100 | |
Contact: Emilio Marangio, MD (+39) 0521986182 <emilio.marangio@unipr.it> | |
Sub-Investigator: Alfredo Chetta, MD | |
Principal Investigator: Emilio Marangio, MD | |
Clinica di Malattie dell'Apparato Respiratorio Università di Modena e Reggio Emilia | Recruiting |
Modena, Italy, 41100 | |
Contact: Luca Richeldi, MD 39 059 422 3469 richeldi.luca@unimore.it | |
Principal Investigator: Luca Richeldi, MD | |
Dip. SCIENZE CARDIOLOGICHE, TORACICHE E VASCOLARI UNIVERSITY OF PADOVA | Not yet recruiting |
PADOVA, Italy | |
Contact: Graziella Turato, MD 39 0498218515 graziella.turato@unipd.it | |
Principal Investigator: Graziella Turato, MD |
Study Director: | Francesco Blasi, MD | University of Milan Italy |
Study ID Numbers: | PRIN2005, MIUR 2005067041 PRIN 2005 |
Study First Received: | August 31, 2007 |
Last Updated: | August 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00524095 |
Health Authority: | Italy: Ministry of Health |
prophylaxis Antibiotic inhaled steroids |
bronchiectasis prevalence chronic bronchitis |
Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases Bronchiectasis |
Azithromycin Lung Diseases Fluticasone Bronchitis Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Anti-Infective Agents Respiratory System Agents Bronchial Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents |
Pharmacologic Actions Anti-Bacterial Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |