Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
研究概览
简要总结
Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with intermittent asthma and allergic rhinitis
排除标准
- •children with acute respiratory symptoms in the last 4 weeks
- •children with nasal polyposis or bronchial or respiratory tract infections
- •children with a severe exacerbation of asthma resulting in hospitalization during the last month
研究组 & 干预措施
beclomethasone dipropionate suspension for nebulization
干预措施: beclomethasone dipropionate (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
时间窗: Baseline, 4 weeks
次要结局
- Change in peak expiratory flow (PEF)(Baseline, 4 weeks)
- change in visual analogue scale score for symptoms of rhinitis(Baseline, 4 weeks)
- change in obstructive sleep apnea syndrome score(Baseline, 4 weeks)
- change in forced vital capacity (FVC)(Baseline, 4 weeks)
- change in symptom scores of wheezing(Baseline, 4 weeks)
- change in forced expiratory volume in 1 second (FEV1)(Baseline, 4 weeks)
- change in level of IL-5 in exhaled breath condensate(Baseline, 4 weeks)