A Randomized, DBPC, Multi-national Phase II/III Study of the Safety and Efficacy of Two Doses of Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From HDM Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 509
- 主要终点
- Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period
研究概览
简要总结
The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
详细描述
Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis.
In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration.
After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 18 to 50 years (inclusive).
- •Patients who have been informed of the nature and aims of the study and have given their written consent
- •Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
- •Female patients of childbearing potential are eligible
- •Negative urine pregnancy test on female patients of childbearing potential.
- •House dust mite-related allergic rhinitis for at least 1 year.
- •Sensitised to D. pteronyssinus or D. farinae (positive SPT with wheal diameter greater than 3 mm and a specific IgE level ≥ 0.7 kU/L).
- •Baseline ARTSS > 5 (after completion of the 7-day daily record card).
- •Patients who are willing to comply with the protocol.
- •Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ.
排除标准
- •Whatever the considered allergens, co-sensitisation leading to clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites).
- •Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).
- •Patients sensitised to cat or dog allergens and living with these animals at home.
- •Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- •Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 1).
- •Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit
- •Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit
- •FEV1 < 80% of predicted value at Visit
- •Patients who received allergy specific immunotherapy for house dust mites in the last 10 years.
- •Patients at risk of non-compliance.
- •Participation in any clinical study within the 12 weeks before Visit
- •Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
- •Any change in environmental measures for allergen avoidance during the study.
研究组 & 干预措施
300 IR
300 IR house dust mites allergen extract tablet
干预措施: 300 IR house dust mites allergen extract tablet (Drug)
500 IR
500 IR house dust mites allergen extract tablet
干预措施: 500 IR house dust mites allergen extract tablet (Drug)
Placebo
Placebo tablet
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period
时间窗: Last 3 months of Year 1
The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12, the higher the score the more severe the rhinitis.
次要结局
- Average Rhinitis Total Symptom Score (ARTSS)(Last 3 months of Year 1)