Dose Tolerability Study With High Dose PURETHAL Mites in Allergic Rhinitis / Rhinoconjunctivitis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection.
研究概览
简要总结
The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.
详细描述
The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be determined by means of the Clinical index score (CIS) and two surrogate efficacy markers; the conjunctival provocation test (CPT) and serum levels of allergen specific immunoglobulins (IgG and IgE). These efficacy parameters are purely indicative and not decisive for the further clinical development of PURETHAL Mites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years. with allergic symptoms related to HDM
- •Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml
- •Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm)
- •Specific serum IgE-test (ssIgE > 0.7 U/ml) for HDM
- •Age ≥ 18 years
- •Written informed consent given
排除标准
- •Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm) to other allergens than HDM should not be included if they have clinical symptoms at the time of inclusion, related to the other allergen
- •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 Beta-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 judicial order
研究组 & 干预措施
Slow regimen
干预措施: PURETHAL Mites 20,000 AUeq/ml (Drug)
Intermediate regimen
干预措施: PURETHAL Mites 20,000 AUeq/ml (Drug)
Fast regimen
干预措施: PURETHAL Mites 20,000 AUeq/ml (Drug)
结局指标
主要结局
Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection.
时间窗: 17, 14 or 11 weeks per patient for the respective groups
次要结局
- Late Local Reactions (LLR) occurring within 24 hours after injection, and systemic reactions (SR). General adverse events will be recorded during complete study period.(17, 14 or 11 weeks per patient for the respective groups)
- Clinical index score (CIS) during the study compared to baseline score (before treatment).(weekly during per patient treatment periods of 17, 14 or 11 weeks for the respective groups)
- Conjunctival provocation test one week after reaching 10,000 AUeq, 20,000 AUeq, or 40,000 AUeq for the respective groups compared to baseline.(after 7 weeks of treatment)
- Conjunctival provocation test 2 weeks after the patients have received two maintenance dosages compared to baseline score.(17, 14 or 11 weeks for the respective treatment groups)
- Specific IgE and IgG measured 2 weeks after the patients have received two maintenance dosages compared to baseline score.(17, 14 or 11 weeks for the respective treatment groups)