Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- comparison between groups of bacterial load in sputum
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Concomitant lung diseases (e.g. lung cancer)
- •Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.
Arms & Interventions
ICS/LABA group
Patients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination
Intervention: Salmeterol/Fluticasone combination (Drug)
LABA group
Patients assigned to this arm will take bid 50 mcg salmeterol
Intervention: Salmeterol (Drug)
Outcomes
Primary Outcomes
comparison between groups of bacterial load in sputum
Time Frame: 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 Outcomes
- Sputum viral and/or bacterial load and exacerbation rate(1 year)
- Correlations between clinical outcomes and sputum viral and/or bacterial load(1 year)
- Sputum viral and/or bacterial load and lung function(1 year)
- Airway inflammation and viral/bacterial load in COPD(1 year)
Investigators
Alberto Papi, MD
Professor in Respiratory Medicine
Università degli Studi di Ferrara