EUCTR2006-001795-20-SE进行中（未招募）不适用
A phase II-III trial assessing the efficacy and safety of three doses of the ALK HDM tablet in house dust mite allergic subjects
试验速览
- 阶段
- 不适用
- 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
- •Males and females aged 14 years and above
- •A clinical history of house dust mite induced mild to moderate persistent asthma of at least one year prior to trial entry.
- •Use of an appropriate amount of inhaled corticosteroid (in accordance with the Gina Guidelines) for the control of the mild to moderate persistent asthma symptoms for a period of 6 month within the past year.
- •At randomisation the asthma is considered stable and the intake of budesonide is <800 mcg/day
- •A clinical history consistent with mild to severe house dust mite induced allergic rhinitis for at least one year.
- •Positive Skin Prick Test (SPT) response (wheal diameter >3mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- •Positive specific IgE (>IgE Class 2) against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- •A documented history of reversible airway obstruction.
- •Are the trial subjects under 18? yes
- •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
- •FEV1 < 70% of predicted value with appropriate medication.
- •A clinical history of perennial allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites)
- •A clinical history of chronic sinusitis
- •A clinical history of severe asthma within the last two years.
- •Current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media not an exclusion criterion).
- •Treatment by immunotherapy with HDM allergen within the previous 5 years.
研究者
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