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Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524095
Recruitment Status : Terminated (we decided not to go on treatment phase)
First Posted : September 3, 2007
Last Update Posted : March 13, 2009
Information provided by:
University of Milan

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiectasis Pulmonary Disease Chronic Bronchitis Drug: azithromycin and fluticasone Drug: fluticasone and azithromycin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bronchiectasis in COPD Patients : Role of Prophylaxis With Inhaled Steroids and Antibiotic on the Natural History of the Disease
Study Start Date : September 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
No Intervention: 1
standard of care
Experimental: 2
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
Other Names:
  • azithromycin
  • fluticasone

Experimental: 3
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
Other Names:
  • fluticasone
  • azithromycin

Primary Outcome Measures :
  1. effects of treatments on bronchial inflammation parameters [ Time Frame: six months ]

Secondary Outcome Measures :
  1. effects of treatments on exacerbations frequency [ Time Frame: six months ]
  2. effects of treatments on pulmonary function [ Time Frame: six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Smokers or former smokers of at least 10 pack-years
  • COPD demonstrated by forced spirometry with FEV1 > 0,7 L, FEV1 post-BD <60% and FEV1/FVC < 70%
  • Bronchodilator test performed at inclusion or no more than 6 months before inclusion should have been negative (increase in FEV1 < 200 ml and 12%, 10 minutes after administration of 2 puffs of salbutamol
  • Stable phase defined by clinical criteria of the attending investigator, but at least 6 weeks from the last exacerbation
  • Informed consent

Exclusion Criteria:

  • Patients receiving oral corticosteroids at any dose or another immunosuppressor
  • Formal contraindication for sputum collection or impossibility to obtain a sample of sputum valid for analysis.
  • Allergy to steroids or macrolides

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 identifier (NCT number): NCT00524095

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Istituto Malattie Respiratorie University of Milan
Milan, Italy, 20122
Clinica di Malattie dell'Apparato Respiratorio Università di Modena e Reggio Emilia
Modena, Italy, 41100
Padova, Italy
Dip. SCIENZE CLINICHE Università degli Studi di PARMA
Parma, Italy, 43100
Sponsors and Collaborators
University of Milan
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Study Director: Francesco Blasi, MD University of Milan Italy
Additional Information:
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Responsible Party: Francesco Blasi, University of Milan Identifier: NCT00524095    
Other Study ID Numbers: PRIN2005
MIUR 2005067041 PRIN 2005
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009
Keywords provided by University of Milan:
inhaled steroids
chronic bronchitis
Additional relevant MeSH terms:
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Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Bacterial Agents
Anti-Infective Agents