EUCTR2008-006261-81-DE进行中（未招募）不适用
Dose Tolerability Study with High Dose PURETHAL Mites in Allergic Rhinitis / Rhinoconjunctivitis Patients. An open study to assess tolerability, safety and short-term efficacy of high dose PURETHAL Mites in patients with allergic rhinitis / rhinoconjunctivits induced by house dust mites. - PURETHAL Mites DTS
HAL Allergy0 个研究点开始时间: 2009年3月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years (their allergic symptoms must be related to HDM)
- •Positive CPT test to HDM Der p and Der f, dose =10,000 AUeq/ml
- •Positive SPT to HDM Der p and Der f (mean wheal diameter = 3mm)
- •Specific serum IgE-test (ssIgE > 0.7 U/ml) for HDM
- •Age = 18 years
- •Patients must give a written informed consent prior to inclusion
- •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
- •Concomitant sensitization i.e. positive SPT (mean wheal diameter = 3 mm) to other allergens than HDM, grass pollen, tree pollen or pets
- •Patients sensitized to grass pollen should not be starting treatment or evaluated during the period of grass pollen exposure
- •Patients sensitized to tree pollen should not be starting treatment or evaluated during the period of tree pollen exposure
- •Patients sensitized to both grass - and tree pollen
- •Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms
- •Immunotherapy (including sublingual) with HDM within the last 5 years
- •Immunotherapy (including sublingual) during the study period
- •Chronic asthma or emphysema, particularly with a FEV1 = 70% of predicted value or use of inhalation corticosteroids
- •Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
- •Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
- •Diseases with a contra-indication for the use of adrenaline
- •Patients who are using other aluminium preparations, e.g. antacids
- •Severe kidney disease
- •Use of systemic steroids
- •Treatment with systemic and local ß-blockers or immunosuppressive drugs
- •Active infection of the target organs (nose or eyes)
- •Severe atopic dermatitis in case systemic immunosuppressive medication is used
- •Participation in a clinical study with a new investigational drug within the last 3 months
- •Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill)
- •Alcohol- or drug abuse
- •Lack of co-operation or severe psychological disorders
- •Institutionalisation by official or judical order
研究者
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