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临床试验/NCT00961155
NCT00961155Unknown2 期

Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
200
试验地点
1
主要终点
Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.

研究概览

简要总结

Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.

详细描述

Markers that can be identified in the EBC of patients with asthma include pH, hydrogen peroxide, nitrogen oxides, eicosanoids, isoprostanes, adenosine, certain cytokines, chemokines, and growth factors. Concentrations of these biomarkers are influenced by inflammation, oxidative stress, and can be modulated by therapeutic interventions. There is evidence that some markers in EBC differ between patients with asthma and controls, and some of them can correlate with asthma severity score, lung function. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. We will also evaluate the effect of antiasthmatic treatment applied out of dust season on the number of exacerbations in "asthma epidemic" in September. We will evaluate the effect of exposure to tobacco smoke on antiasthmatic treatment.

Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction (EIB) as another phenotype of asthma. At the first study vist patients with EIB underwent fractional exhaled nitric oxide measurement (FeNO) and baseline spirometry, performed exercise treadmill challenge (ETC) and EBC samples were obtained at the end of ETC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children with mild to moderate asthma allergic to house dust mite exposed/nonexposed to tobacco smoke
  • healthy children

排除标准

  • sensitization to allergens other than house dust mites
  • other chronic diseases
  • asthma exacerbation
  • pregnancy
  • oral corticosteroids for 4 weeks before the study
  • montelukast sodium for 2 weeks before the study

研究组 & 干预措施

cyklezonid

Active Comparator

children will receive 160 mcg once daily cyklezonid for 3 months

干预措施: cyklezonid (Drug)

montelukast sodium

Active Comparator

children will receive 5 or 10 mg montelukast sodium for 3 months

干预措施: montelukast sodium (Drug)

placebo

Placebo Comparator

children will receive placebo for 8 weeks out of allergy season to house dust mite

干预措施: placebo (Drug)

formoterol

Active Comparator

children will receive formoterol aerolzol 12mcg twice daily for 3 months

干预措施: formoterol 12 mcg twice daily (Drug)

结局指标

主要结局

Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.

时间窗: visit 1-6

次要结局

  • Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation(visits 1-6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iwona Stelmach

MD, PhD, Professor

Medical University of Lodz

研究点 (1)

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