Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Bacteria, Virus, Inhaled Corticosteroids
Brief summary
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.
Interventions
DRUGSalmeterol/Fluticasone combination
Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid
DRUGSalmeterol
Salmeterol 50 mcg 1 inhalation bid
Sponsors
GlaxoSmithKline
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparison between groups of bacterial load in sputum | 1 year | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlations between clinical outcomes and sputum viral and/or bacterial load | 1 year | To evaluate whether sputum viral and/or bacterial load correlate with symptoms and need for rescue medication in stabile COPD. |
| Sputum viral and/or bacterial load and exacerbation rate | 1 year | To evaluate whether changes in sputum viral and/or bacterial load (end of the study vs baseline) correlate with exacerbation rate in COPD patients |
| Sputum viral and/or bacterial load and lung function | 1 year | To evaluate correlations between changes in sputum viral and/or bacterial load and changes in lung function over 1 year. |
| Airway inflammation and viral/bacterial load in COPD | 1 year | 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. |
Countries
Italy
Outcome results
None listed