Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients
Exacerbations are important events in the natural history of chronic obstructive pulmonary
disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that
exacerbations negatively affect the natural history of the disease; e.g. lung function
decline is accelerated in patients with frequent exacerbations. Bacteria are considered the
most relevant cause of exacerbations, but there is evidence that viral infections are
equally contributing.
Either alone or in combination with viruses, airway bacterial load in stable COPD correlates
with both the frequency of exacerbations and the decline in lung function.
A long-term clinical trial recently showed that the regular treatment with inhaled
corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it
reduces the frequency of acute COPD exacerbations in COPD.
In a recent study it was found that airway bacterial load increases over time (1 yr follow
up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.
This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral
and/or bacterial load in the sputum of COPD patients.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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