Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD

Hospital Son Llatzer

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Fluticasone; Drug: Inhaled Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02209974

IC-COPD-2014

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.

Full description

Physical exercise produces a systemic inflammatory response, both in the healthy individual and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005; Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res 2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains unknown.

This study explores the hypothesis that the inflammatory response induced by exercise in COPD patients could be with IC treatment.

Enrollment: 23 patients

Sex: Male

Ages: 58 to 72 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• ex-smokers (> 10 packets-year) with moderate-severe COPD patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

Inhaled Placebo

Placebo Comparator group

Description:

Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients

Treatment:

Drug: Inhaled Placebo

Inhaled corticosteroids (Fluticasone, 0.5 mg)

Experimental group

Description:

Inhaled corticosteroids administered to the other half (n=8) of COPD patients

Treatment:

Drug: Fluticasone