Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua: a Randomized, Double Blind,Placebo Controlled, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 702
- 试验地点
- 13
- 主要终点
- daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS)
研究概览
简要总结
Allergic rhinitis (AR) is a common disease of nasal mucosa, affecting 10% to 40% of the population globally. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.Traditionally, AIT is divided into subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October.
The trial is a randomized, double-blind, placebo-controlled, multicentred, phase III trial. 702 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and placebo group.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of seasonal rhinitis symptoms for over 2 years
- •artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) of class 3 or higher
- •patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
- •patients who are able to understand the information given and the consent and complete the daily record card.
排除标准
- •patients with severe asthma, perennial allergic rhinitis, cancer or other serious diseases that are unfit to receive allergen immunotherapy
- •patients who are taking β-antagonists or have taken systemic corticosteroids in last 4 weeks
- •patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
研究组 & 干预措施
artemisia annua allergen extract drops
干预措施: AIT drops (Drug)
Placebo drops
干预措施: placebo drops (Drug)
结局指标
主要结局
daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS)
时间窗: at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day)
the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score
次要结局
- Adverse events(From the first day of SLIT to Visit 9(week 32))
- daily total nasal symptom score (dTNSS)(at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day))
- daily Rescue Medication Scores (dRMS)(at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day))
研究者
Luo Zhang
vise president of BeijingTongren Hospital
Beijing Tongren Hospital