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临床试验/NCT02209974
NCT02209974已完成4 期

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

Hospital Son Llatzer1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2004年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Differences in response to exercise between healthy and COPD patients

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
58 Years 至 72 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Inhaled Placebo

Placebo Comparator

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

干预措施: Inhaled Placebo (Drug)

Inhaled corticosteroids (Fluticasone, 0.5 mg)

Experimental

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

干预措施: Fluticasone (Drug)

结局指标

主要结局

Differences in response to exercise between healthy and COPD patients

时间窗: 1 month

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, %

次要结局

未报告次要终点

研究者

发起方
Hospital Son Llatzer
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonia Fuster

Medicine PhD

Hospital Son Llatzer

研究点 (1)

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