An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 430
- 主要终点
- Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])
研究概览
简要总结
The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously completed clinical study CP007 [NCT01620762]
排除标准
- •started allergen therapy since completing CP007
- •Institutionalised due to a legal or regulatory order
研究组 & 干预措施
Cat-PAD Treatment 1
Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A
干预措施: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762] (Drug)
Cat-PAD Treatment 2
Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A.
干预措施: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] (Drug)
Cat-PAD Treatment 3
Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A.
干预措施: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] (Drug)
结局指标
主要结局
Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])
时间窗: 1 year after completing CP007
The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). 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 TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.
次要结局
- Mean Component Scores of the TRSS (Nasal)(1 year after completion of CP007)
- Mean Allergy Medication Score (AMS)(1 year after completion of CP007)
- Mean RQLQ Score(1 year after completion of CP007)
- Mean Component Scores of the TRSS (Ocular)(1 year after completion of CP007)
- Mean TRSS(1 year after completion of CP007)