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Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01213693
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
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 2009
Primary Completion Date : May 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :
  1. comparison between groups of bacterial load in sputum [ Time Frame: 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 :
  1. Correlations between clinical outcomes and sputum viral and/or bacterial load [ Time Frame: 1 year ]
    To evaluate whether sputum viral and/or bacterial load correlate with symptoms and need for rescue medication in stabile COPD.

  2. Sputum viral and/or bacterial load and exacerbation rate [ Time Frame: 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

  3. Sputum viral and/or bacterial load and lung function [ Time Frame: 1 year ]
    To evaluate correlations between changes in sputum viral and/or bacterial load and changes in lung function over 1 year.

  4. Airway inflammation and viral/bacterial load in COPD [ Time Frame: 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

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by Alberto Papi, MD, Università degli Studi di Ferrara:
Inhaled Corticosteroids

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