The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 207
- 主要终点
- Time to Onset of Asthma
研究概览
简要总结
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).
36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)
- •Having completed the previous 18-month treatment period of the EPAAC trial - NCT00152464
排除标准
- 未提供
研究组 & 干预措施
LCTZ-LCTZ
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
干预措施: LEVOCETIRIZINE (Drug)
LCTZ-PLC
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)
干预措施: Placebo (Other)
PLC-PLC
Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)
干预措施: Placebo (Other)
结局指标
主要结局
Time to Onset of Asthma
时间窗: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
次要结局
- Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.(18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.))