Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- change from baseline symptom scores at Week 16
研究概览
简要总结
Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), both of which are effective and safe alternatives.
The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week SLIT schedule, where the maintenance dose would be reached within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were administered by means of sublingual drops.
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
- •Male or female outpatients aged 18 to 60 years (inclusive).
- •With history of SAR for at least two years, with/without conjunctivitis and asthma
- •Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- •Sensitised to artemisia annua (specific IgE level ≥ 3.5 kilounit per liter).
- •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 whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
- •Patients with oral diseases/ allergies within the run-in period.
- •Patients accepted any kind of operations within 4 weeks of the run-in period.
- •Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- •Patients with perennial AR.
- •Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
- •Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
- •Patients with comorbidity of severe asthma.
研究组 & 干预措施
artemisia annua (sweet sagewort) allergen extract drops
Drug: sublingual immunotherapy drops
干预措施: sublingual immunotherapy drops (Drug)
Placebo drops
Drug: sublingual placebo drops
干预措施: Placebo drops (Drug)
结局指标
主要结局
change from baseline symptom scores at Week 16
时间窗: at baseline, Week 16
Primary outcome is the assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales, ranging from 0(asymptomatic) to 3(most severe).
次要结局
- Quality of life(at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment)
- Medication scores(at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment)
- Immunologic Changes-IgE(at baseline, Week 16, Week 32)
- Immunologic Changes-M2 population(at baseline, Week 16, Week 32)
- Change of symptom scores(at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment)
研究者
Luo Zhang
President, Beijing TongRen Hospital
Beijing Tongren Hospital