Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

NCT01213693 | Completed

• 1 other identifier: LTEICSBV01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Bacteria; Virus; Inhaled Corticosteroids

Outcome Measures

Primary Outcomes (1)

• comparison between groups of bacterial load in sputum

  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)

  1 year

Secondary Outcomes (4)

• Correlations between clinical outcomes and sputum viral and/or bacterial load

  1 year

• Sputum viral and/or bacterial load and exacerbation rate

  1 year

• Sputum viral and/or bacterial load and lung function

  1 year

• Airway inflammation and viral/bacterial load in COPD

  1 year

Study Arms (2)

ICS/LABA group

EXPERIMENTAL

Patients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination

Drug: Salmeterol/Fluticasone combination

LABA group

ACTIVE COMPARATOR

Patients assigned to this arm will take bid 50 mcg salmeterol

Drug: Salmeterol

Interventions

Salmeterol/Fluticasone combination DRUG

Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid

ICS/LABA group

Salmeterol DRUG

Salmeterol 50 mcg 1 inhalation bid

LABA group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Atopy
• Asthma
• Concomitant lung diseases (e.g. lung cancer)
• Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

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

Ferrara, 44121, Italy

Location

Related Publications (1)

• Contoli M, Pauletti A, Rossi MR, Spanevello A, Casolari P, Marcellini A, Forini G, Gnesini G, Marku B, Barnes N, Rizzi A, Curradi G, Caramori G, Morelli P, Papi A. Long-term effects of inhaled corticosteroids on sputum bacterial and viral loads in COPD. Eur Respir J. 2017 Oct 5;50(4):1700451. doi: 10.1183/13993003.00451-2017. Print 2017 Oct.

  PMID: 28982774 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Virus Diseases

Interventions

Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Alberto Papi, MD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Respiratory Medicine

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

IT (1)