Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

This study has been completed.
Information provided by (Responsible Party):
Alberto Papi, MD, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
First received: October 1, 2010
Last updated: April 6, 2016
Last verified: April 2016

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 Intervention
Chronic Obstructive Pulmonary Disease
Drug: Salmeterol/Fluticasone combination
Drug: Salmeterol

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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.

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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:

  • Atopy
  • Asthma
  • Concomitant lung diseases (e.g. lung cancer)
  • Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01213693

Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara
Principal Investigator: Alberto Papi, MD Università degli Studi di Ferrara
  More Information

Responsible Party: Alberto Papi, MD, Professor in Respiratory Medicine, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT01213693     History of Changes
Other Study ID Numbers: LTEICSBV01 
Study First Received: October 1, 2010
Last Updated: April 6, 2016
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
Inhaled Corticosteroids

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on May 01, 2016