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

This study has been terminated.
(we decided not to go on treatment phase)
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00524095
First received: August 31, 2007
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

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
Bronchiectasis
Pulmonary Disease
Chronic Bronchitis
Drug: azithromycin and fluticasone
Drug: fluticasone and azithromycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • effects of treatments on bronchial inflammation parameters [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effects of treatments on exacerbations frequency [ Time Frame: six months ] [ Designated as safety issue: No ]
  • effects of treatments on pulmonary function [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524095

Locations
Italy
Istituto Malattie Respiratorie University of Milan
Milan, Italy, 20122
Clinica di Malattie dell'Apparato Respiratorio Università di Modena e Reggio Emilia
Modena, Italy, 41100
Dip. SCIENZE CARDIOLOGICHE, TORACICHE E VASCOLARI UNIVERSITY OF PADOVA
Padova, Italy
Dip. SCIENZE CLINICHE Università degli Studi di PARMA
Parma, Italy, 43100
Sponsors and Collaborators
University of Milan
Investigators
Study Director: Francesco Blasi, MD University of Milan Italy
  More Information

Additional Information:
No publications provided

Responsible Party: Francesco Blasi, University of Milan
ClinicalTrials.gov Identifier: NCT00524095     History of Changes
Other Study ID Numbers: PRIN2005, MIUR 2005067041 PRIN 2005
Study First Received: August 31, 2007
Last Updated: March 12, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by University of Milan:
prophylaxis
Antibiotic
inhaled steroids
bronchiectasis
prevalence
chronic bronchitis

Additional relevant MeSH terms:
Bronchiectasis
Bronchitis
Bronchitis, Chronic
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Azithromycin
Fluticasone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014