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OpenTrials
Completed

NCT Number: NCT01213693

Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmeterol/Fluticasone combination

Drug

Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid

Salmeterol

Drug

Salmeterol 50 mcg 1 inhalation bid

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2010
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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