Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

Sponsor

Università degli Studi di Ferrara (Other)

Overall Status

Completed

CT.gov ID

NCT01213693

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Salmeterol/Fluticasone combination Drug: Salmeterol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Salmeterol Salmeterol 50 mcg 1 inhalation bid

Arm

Intervention/Treatment

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

Drug: Salmeterol

Salmeterol 50 mcg 1 inhalation bid

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara	Ferrara		Italy	44121