EUCTR2010-018621-19-SK进行中（未招募）1 期
Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma. The MITRA Trial. - MITRA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent obtained before entering the trial.
- •Male or female = 18 years.
- •A clinical relevant history consistent with HDM-induced asthma of at least 1 year prior to trial entry.
- •Use of asthma medication (e.g. combination products) for the control of asthma symptoms for a period of at least 6 months within the past year.
- •Dose of ICS after switching should at randomisation be in a range of budesonide 400-800 mcg.
- •Documented reversible airway obstruction.
- •Asthma control level above or equal to 1.0 (asthma control questionnaire (ACQ) = 1.0) at visit 1 (screening).
- •Asthma control level between 1.0 and 1.5 (1.0 = ACQ = 1.5) at visit 3 (randomisation).
- •Electronic diary compliance rate between visit 2 and visit 3 = 80% at visit 3 (randomisation)
- •FEV1 > 60% of predicted value.
- •A clinical history consistent with HDM-induced allergic rhinitis for at least 1 year.
- •Positive SPT response (wheal diameter = 3 mm larger than the negative control) to Der pte and/or Der far.
- •Positive specific IgE against Der pte and/or Der far (= IgE Class 2; = 0.70 KU/L).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A clinical history of persistent allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized (except HDM).
- •A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period of the year corresponding the ICS reduction period (period 3)
- •Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
- •Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.
研究者
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