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Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

NCT01213693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Salmeterol/Fluticasone combination

Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid

DRUG

Salmeterol

Salmeterol 50 mcg 1 inhalation bid

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Università degli Studi di Ferrara

    lead OTHER

Principal Investigators

  • Alberto Papi, MD · Università degli Studi di Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213693 on ClinicalTrials.gov