A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score
研究概览
简要总结
A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis
详细描述
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
The proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.
- •Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.
- •Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.
- •Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
- •Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
排除标准
- •Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.
- •Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening
结局指标
主要结局
To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score
时间窗: 5 weeks
次要结局
未报告次要终点