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

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

Detailed Description
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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.

Official Title
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Inhaled Corticosteroids do Not Modify the Systemic Inflammation Induced by Exercise in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Fluticasone
* Drug: Inhaled Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ex-smokers (> 10 packets-year) with moderate-severe COPD patients

Ages Eligible for Study
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Minimum Age: 58 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Inhaled Placebo<br>Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients | Drug: Inhaled Placebo<br> <br> |
| Experimental: Inhaled corticosteroids (Fluticasone, 0.5 mg)<br>Inhaled corticosteroids administered to the other half (n=8) of COPD patients | Drug: Fluticasone<br>* Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.<br>* Other names: Inhaled Corticosteroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in response to exercise between healthy and COPD patients | 16 COPD patients were compared with 7 healthy, sedentary and nonsmoker controls. All of them carried out an incremental cycle exercise test (ICET) limited by symptoms. 1 month later, ICET was repeated only by COPD patients. Venous blood samples were obtained at rest and during peak exercise. Anthropometric, functional and response characteristics to exercise: Age, years BMI, m2.kg-1 FEV1/FVC, % FEV1, % reference Peak charge, watts VO2 peak, mL.min-1 Respiratory quotient VE peak, L.min-1 Fc peak, lpm Lactic acid peak, mmol.L-1 SaO2 basal, % SaO2 peak, % | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emphysema, CRP, interleukin-8, dynamic hyperinflation