NCT01918956已完成4 期
A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis
HAL Allergy16 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Proportion of patients successfully reaching the maintenance dose
研究概览
简要总结
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).
The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes.
A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age ≥12 years.
- •Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
- •FEV1>70% for patients with a history of mild to moderate asthma, FEV1>70% or PEF>80% for patients without a history of asthma
- •A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen.
- •Positive serum specific anti-birch IgE-test (>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization.
排除标准
- •Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
- •Any specific immunotherapy (SCIT or SLIT) during the study period
- •Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- •Active malignancies or any malignant disease within the past 5 years
- •Severe uncontrolled diseases that could increase the risk for patients participating in the study
- •Acute/active inflammation or infection of the target organs at the start of the study
- •Secondary changes of the target organ
- •Diseases with a contraindication for the use of adrenaline
- •Use of systemic steroids within 4 weeks before start of the study and during the study
- •Treatment with systemic and local β-blockers
- •Vaccination within one week before start of therapy or during the initiation phase
- •Anti-IgE therapy within the 6 months prior to inclusion and during the study
- •Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
- •Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age
- •Alcohol, drug or medication abuse within the past year
- •Any clinically significant abnormal laboratory parameter at screening
- •Lack or expected lack of cooperation or compliance
- •Severe psychiatric, psychological, or neurological disorders
- •Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator
结局指标
主要结局
Proportion of patients successfully reaching the maintenance dose
时间窗: 12 weeks
次要结局
- Immunological parameters (IgE, IgG)(10 weeks rush regime, 13 weeks conventional regime)
- Early and late local and systemic reactions(30 minutes after IMP injection and 24 hours after injection)
研究者
研究点 (16)
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