Clinical trial NCT01213693: Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD
Official title: Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Bacteria
Virus
Inhaled Corticosteroids
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: comparison between groups of bacterial load in sputum
timeFrame: 1 year
Secondary outcomes:
measure: Correlations between clinical outcomes and sputum viral and/or bacterial load
timeFrame: 1 year
measure: Sputum viral and/or bacterial load and exacerbation rate
timeFrame: 1 year
measure: Sputum viral and/or bacterial load and lung function
timeFrame: 1 year
measure: Airway inflammation and viral/bacterial load in COPD
timeFrame: 1 year
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara
Study officials:
affiliation: Università degli Studi di Ferrara
name: Alberto Papi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.