NCT03718793招募中不适用
Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma
研究概览
简要总结
Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria
- •significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %)
- •in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring
- •significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)
排除标准
- •current smoking
- •regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment)
- •other chronic pulmonary disease
- •other diseases that in the opinion of the treating physician prevents participation
结局指标
主要结局
Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma
时间窗: Baseline
Change in peripheral NO output
Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma
时间窗: Baseline
Change in peripheral airway resistance
次要结局
- Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma(Baseline)
- Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls(Baseline)
- Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma(Baseline)
研究者
Lauri Lehtimäki
Associate professor
Tampere University Hospital
研究点 (2)
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