NCT01433523已完成3 期
Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 834
- 试验地点
- 1
- 主要终点
- Time to first moderate or severe asthma exacerbation after ICS reduction
研究概览
简要总结
The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical relevant history consistent with house dust mite induced asthma of at least 1 year prior to trial entry.
- •Use of an appropriate amount of inhaled corticosteroid for the control of asthma symptoms.
- •Documented reversible airway obstruction.
- •Suitable level of asthma control.
- •FEV1 ≥ 70% of predicted value.
- •Positive Skin Prick Test response to Der pte and/or Der far.
- •Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L).
排除标准
- •A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites).
- •A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period from October to March.
- •Any clinically relevant chronic disease.
研究组 & 干预措施
ALK HDM AIT 6 DU
Experimental
干预措施: ALK HDM AIT 6 DU (Drug)
Placebo
Placebo Comparator
干预措施: ALK HDM AIT Placebo (Drug)
ALK HDM AIT 12 DU
Experimental
干预措施: ALK HDM AIT 12 DU (Drug)
结局指标
主要结局
Time to first moderate or severe asthma exacerbation after ICS reduction
时间窗: Measured during the last 6 months of the trial
次要结局
- Difference in changes in immunological parameters (IgE, IgG4)(Measured at the end of the trial)
- Time to first severe asthma exacerbation after ICS reduction(Measured during the last 6 months of the trial)
- Frequency of asthma exacerbations following ICS reduction(Measured during the last 6 months of the trial)
- The average overall symptom score.(Measured during the last 6 months of the trial)
- Symptom free days(Measured during the last 6 months of the trial)
- Number and percentage of subjects with treatment emergent AEs(At end of trial)
研究者
研究点 (1)
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