Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis
Status:
Terminated
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
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.