A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 715
- 主要终点
- Combined Score of Symptoms and Allergy Medication
研究概览
简要总结
The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-65 years.
- •Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.
- •Mean TRSS ≥10
- •Positive skin prick test to Der p and Der f.
- •Dep p and Der f specific IgE ≥0.7 kU/L
排除标准
- •Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org)or higher treatment
- •FEV1 <80% of predicted.
- •Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
- •Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
- •Clinically relevant abnormalities detected on physical examination.
- •History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
研究组 & 干预措施
HMD-SPIRE Treatment 1
4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart
干预措施: HDM-SPIRE (Drug)
HMD-SPIRE Treatment 1
4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart
干预措施: Placebo (Drug)
HDM-SPIRE Treatment 2
4 x 12 nmol HDM-SPIRE 4 weeks apart followed by a second course of 4 x 12 nmol HDM-SPIRE 4 weeks apart
干预措施: HDM-SPIRE (Drug)
HDM-SPIRE Treatment 3
4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart
干预措施: HDM-SPIRE (Drug)
HDM-SPIRE Treatment 3
4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart
干预措施: Placebo (Drug)
Placebo
8 x placebo 4 weeks apart
干预措施: Placebo (Drug)
结局指标
主要结局
Combined Score of Symptoms and Allergy Medication
时间窗: Weeks 50 to 52 after randomisation
The primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue 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 non-nasal 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); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3. The RMS score ranged 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 RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo(Weeks 50 to 52 after randomisation)
- Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline(Weeks 50 to 52 after randomisation)
- Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo(Weeks 50 to 52 after randomisation)
- Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo(Weeks 50 to 52 after randomisation)
- Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo(Weeks 50 to 52 after randomisation)
- Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo(Weeks 50 to 52 after randomisation)
- Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo(Weeks 50 to 52 after randomisation)