Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

NCT ID: NCT01213693

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ICS/LABA group

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

Group Type: EXPERIMENTAL

Salmeterol/Fluticasone combination

Intervention Type: DRUG

Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid

LABA group

Patients assigned to this arm will take bid 50 mcg salmeterol

Group Type: ACTIVE_COMPARATOR

Salmeterol

Intervention Type: DRUG

Salmeterol 50 mcg 1 inhalation bid

Interventions

Salmeterol/Fluticasone combination

Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid

Intervention Type: DRUG

Salmeterol

Salmeterol 50 mcg 1 inhalation bid

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Alberto Papi, MD

Professor in Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Papi, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

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

Ferrara, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28982774 (View on PubMed)

Other Identifiers

LTEICSBV01

Identifier Type: -

Identifier Source: org_study_id