Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD
Recruitment status was Recruiting
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.
Chronic Obstructive Pulmonary Disease
Drug: Salmeterol/Fluticasone combination
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients|
- comparison between groups of bacterial load in sputum [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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)
- Correlations between clinical outcomes and sputum viral and/or bacterial load [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: ICS/LABA group
Patients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination
Drug: Salmeterol/Fluticasone combination
Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid
Active Comparator: LABA group
Patients assigned to this arm will take bid 50 mcg salmeterol
Salmeterol 50 mcg 1 inhalation bid
|Contact: Alberto Papi, MDfirstname.lastname@example.org|
|Contact: Marco Contoli, MDemail@example.com|
|Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara||Recruiting|
|Ferrara, Italy, 44121|
|Contact: Alberto Papi, MD +390532236908 firstname.lastname@example.org|
|Contact: Marco Contoli, MD +390532236908 email@example.com|
|Principal Investigator: Alberto Papi, MD|
|Sub-Investigator: Marco Contoli, MD|
|Principal Investigator:||Alberto Papi, MD||Università degli Studi di Ferrara|