A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Daily Rhinoconjunctivitis Symptom Score
研究概览
简要总结
The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy
详细描述
Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of birch pollen allergy
- •Positive skin prick test to birch
- •Positive conjunctival test to birch
- •Positive specific Immunoglobulin E (IgE) to birch
排除标准
- •Forced expiratory volume in 1 second (FEV1)<70% of predicted value
- •History of seasonal allergy interfering with study
- •History of symptomatic perennial allergy
- •History of emergency visit or admission for asthma in the previous 12 month
研究组 & 干预措施
Sublingual immunotherapy
sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
干预措施: Sublingual immunotherapy (Biological)
Placebo
placebo sublingual drops
干预措施: Placebo (Biological)
结局指标
主要结局
Daily Rhinoconjunctivitis Symptom Score
时间窗: Birch pollen season 2006
A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Daily Rhinoconjunctivitis Rescue Medication Score
时间窗: Birch pollen season 2006
Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).
次要结局
- Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects(Birch pollen season 2006)
- Adverse Events(Birch pollen season 2006)