Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD
This study is currently recruiting participants.
Verified October 2010 by Università degli Studi di Ferrara
Sponsor:
Università degli Studi di Ferrara
Collaborator:
GlaxoSmithKline
Information provided by:
Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01213693
First received: October 1, 2010
Last updated: November 24, 2010
Last verified: October 2010
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Purpose
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.
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2012 (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
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213693
Contacts
| Contact: Alberto Papi, MD | +390532236908 | ppa@unife.it |
| Contact: Marco Contoli, MD | +390532236908 | ctm@unife.it |
Locations
| Italy | |
| Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara | Recruiting |
| Ferrara, Italy, 44121 | |
| Contact: Alberto Papi, MD +390532236908 ppa@unife.it | |
| Contact: Marco Contoli, MD +390532236908 ctm@unife.it | |
| Principal Investigator: Alberto Papi, MD | |
| Sub-Investigator: Marco Contoli, MD | |
Sponsors and Collaborators
Università degli Studi di Ferrara
GlaxoSmithKline
Investigators
| Principal Investigator: | Alberto Papi, MD | Università degli Studi di Ferrara |
More Information
No publications provided
| Responsible Party: | Alberto Papi, University of Ferrara |
| ClinicalTrials.gov Identifier: | NCT01213693 History of Changes |
| Other Study ID Numbers: | LTEICSBV01 |
| Study First Received: | October 1, 2010 |
| Last Updated: | November 24, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Università degli Studi di Ferrara:
|
COPD Bacteria Virus Inhaled Corticosteroids |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013