Comparative Study of Novel and Conventional Dose Adjustment Schedules for Late Injection of More Than 16 Weeks in Subcutaneous Immunotherapy in Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The change of Combined Symptom and Medication Score
研究概览
简要总结
Allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. The aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (DM) SCIT of AR subjects.
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
- None
入排标准
- 年龄范围
- 5 Years 至 53 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 18 to 60 years;
- •(2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
- •(3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
- •(4) hope to continue to complete the entire treatment and have good compliance.
排除标准
- •(1) diagnosed as asthma based on the guidelines of the Global Initiative for Asthma(13);
- •(2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.
结局指标
主要结局
The change of Combined Symptom and Medication Score
时间窗: baseline, week 3, week 6, week 26.
CSMS which was calculated as follows: (total nasal symptom scores (TNSS))/4+ MS as recommended by European Academy of Allergy and Clinical Immunology (EAACI) Position Paper. The CSMS score was 0-6, 0 for good therapeutic effect and 6 for poor therapeutic effect.
次要结局
- The change of medication score(Baseline, week 26.)
- Adverse reactions(week 26.)
- The change of total nasal symptom scores(baseline, week 3, week 6, week 26.)