NCT02560948已完成3 期
A Multicenter, International, Randomised, Double-blind, Placebo Controlled Study to Demonstrate the Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
BioTech Tools S.A.3 个研究点 分布在 3 个国家目标入组 554 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 554
- 试验地点
- 3
- 主要终点
- Combined Symptom and Medication Score (CSMS)
研究概览
简要总结
gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergy diagnosis:
- •A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
- •A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm
- •Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L
- •Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens
- •Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
- •For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)
排除标准
- •Previous immunotherapy with grass allergens within the last 5 years
- •Ongoing immunotherapy with grass allergens or any other allergens
- •Patients with a history of anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
- •Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
- •Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
- •Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
- •Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo solution (Biological)
gpASIT+TM
Experimental
干预措施: gpASIT+TM (Biological)
结局指标
主要结局
Combined Symptom and Medication Score (CSMS)
时间窗: over the peak (corresponding to 14 consecutive days with highest pollen counts) of grass pollen season estimated between 3 and 6 months after treatment
次要结局
- Solicited adverse events(up to 4 weeks)
- Symptom sub-scores (Eyes, Nose)(over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment)
- Use of rescue medication to relief asthma symptoms in asthmatic patients(over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment)
- Well days: number of days with symptomatic score below or equal to 2 and no rescue medication(over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment)
- Lung Symptom Score (LLS: the average of coughing, wheezing, chest tightness and exercise induced dyspnoea scores) in asthmatic patients(over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment)
- Unsolicited adverse events and serious adverse events(up to 8 months)
- Use of rescue medication(up to 4 weeks)
- Total Symptom Score (TSS: the sum of the nose, eye and lung scores) in asthmatic patients(over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment)
- Conjunctival Provocation Test (CPT) outcomes(at baseline and up to 6 weeks)
- Number of working day lost due to grass pollen induced-allergy symptoms(between 2 weeks and 8 months after treatment)
- Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS)(between 2 weeks and 8 months after treatment)
- Physical examinations and vital signs(up to 8 months)
- Laboratory investigations (haematology, clinical biochemistry, immunological parameters)(up to 8 months)
- Combined Symptom and Medication Score (CSMS)(over the entire grass pollen season estimated between 3 and 6 months after treatment)
- Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis(between 2 weeks and 8 months after treatment)
研究者
研究点 (3)
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