A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,408
- 主要终点
- Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo
研究概览
简要总结
The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cat-Pad Treatment 1
Cat-PAD Treatment 1
干预措施: Cat-PAD (Drug)
Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
干预措施: Cat-PAD (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo
时间窗: 52-54 weeks after randomisation
The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3. RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.
次要结局
- Mean Daily TNSS in Cat-PAD Compared With Placebo(52-54 weeks after randomisation)
- Mean Daily TOSS in Cat-PAD Compared to Placebo(52-54 weeks after randomisation)
- Mean RQLQ Score in Cat-PAD Compared With Placebo(52-54 weeks after randomisation)
- Mean RMS in Cat-PAD Compared With Placebo(52-54 weeks after randomisation)
- Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use(52-54 week after randomisaiton)
- Mean TRSS(52-54 weeks after randomisation)