Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 15
- 主要终点
- Symptoms score
研究概览
简要总结
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.
详细描述
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent, signed by the subject
- •Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen
- •Patient of both gender aged from 18 up to 55
- •Diagnosed Sensitivity to Parietaria pollen base on:
- •Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L
- •Patients who are able to comply with the dose regime
排除标准
- •Relevant sensitivity to another perenne allergen
- •Patient with asthma
- •Use of immunotherapy during the last four years
- •Treatment with B. Blocking agents
- •Patient suffering from some pathology in which adrenaline was contraindicated
- •Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study
- •Subject suffers from autoimmune disease(thyroiditis, lupus, etc.)
- •Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance.
- •Intolerance to aspirin
- •Pregnant women or with pregnancy risk and brest-feeding
结局指标
主要结局
Symptoms score
时间窗: 2 years
次要结局
- Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization(2 years)