Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

Università degli Studi di Ferrara

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Salmeterol; Drug: Salmeterol/Fluticasone combination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01213693

LTEICSBV01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ICS/LABA group

Experimental group

Description:

Patients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination

Treatment:

Drug: Salmeterol/Fluticasone combination

LABA group

Active Comparator group

Description:

Patients assigned to this arm will take bid 50 mcg salmeterol

Treatment:

Drug: Salmeterol