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
Verified date | April 2016 |
Source | Università degli Studi di Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines. - GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months Exclusion Criteria: - Atopy - Asthma - Concomitant lung diseases (e.g. lung cancer) - Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Italy | Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara | Ferrara |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Ferrara | GlaxoSmithKline |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparison between groups of bacterial load in sputum | The primary outcome will measure changes in sputum bacterial load of COPD patients treated with inhaled corticosteroids in combination with long acting beta-2 bronchodilators (ICS/LABA group) compared with COPD treated only with long acting beta-2 bronchodilators (LABA group) | 1 year | Yes |
Secondary | Correlations between clinical outcomes and sputum viral and/or bacterial load | To evaluate whether sputum viral and/or bacterial load correlate with symptoms and need for rescue medication in stabile COPD. | 1 year | No |
Secondary | Sputum viral and/or bacterial load and exacerbation rate | To evaluate whether changes in sputum viral and/or bacterial load (end of the study vs baseline) correlate with exacerbation rate in COPD patients | 1 year | No |
Secondary | Sputum viral and/or bacterial load and lung function | To evaluate correlations between changes in sputum viral and/or bacterial load and changes in lung function over 1 year. | 1 year | No |
Secondary | Airway inflammation and viral/bacterial load in COPD | To evaluate correlations between sputum inflammatory cell profiles and markers of airway inflammation (interleukin-6) and viral/bacterial load at stable stable conditions in COPD paetints. | 1 year | No |
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