A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,460
- 试验地点
- 214
- 主要终点
- Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period
研究概览
简要总结
A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)
详细描述
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.
In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).
The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 5-11 years
- •A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
- •Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
- •Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
- •Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
- •Lung function ≥ 70% of predicted value
排除标准
- •Sensitised and regularly exposed to perennial allergens
- •Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
- •Asthma requiring treatment with high dose of inhaled corticosteroid
- •A relevant history of systemic allergic reaction
结局指标
主要结局
Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period
时间窗: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The primary endpoint in the trial was the average daily total combined rhinitis symptoms and medication score (TCRS) during the primary efficacy assessment period. The average daily TCRS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and medication score (on a scale of 0-24). Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCRS values, the primary endpoint is calculated as the average of those values.
次要结局
- The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial(Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment))
- Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- Total IgE(Change from screening to the end of trial (after approximately 52-57 weeks of treatment))
- House Dust Mite IgE-Blocking Factor(Change from screening to the end of trial (after approximately 52-57 weeks of treatment))
- The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- House Dust Mite Specific IgE(Change from screening to the end of trial (after approximately 52-57 weeks of treatment))
- SABA Free Days During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- Rhinitis Mild Days During the Primary Efficacy Assessment Period(8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP)
- House Dust Mite Specific IgG4(Change from screening to the end of trial (after approximately 52-57 weeks of treatment))