Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 14
- 主要终点
- Symptoms and medication score
研究概览
简要总结
The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea 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
- •Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
- •Patients of both gender aged from 18 and 55 years
- •Patient's perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
- •FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
- •Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against Olea europaea pollen. The IgE mediated sensitization has to be verified by:
- •Suggestive medical history
- •Specific IgE against Olea europaea pollen CAP RAST ≥0.7Ku/l
- •Positive skin prick test (SPT) to grass Olea pollen resulting in a wheal diameter of at least 3 mm.
排除标准
- •History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
- •Participation in an immunotherapy with comparable extracts within the last five years.
- •Treatment with β-blocker
- •Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
- •Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
- •Immunopathological diseases
- •Patients who are expected to be non-compliant and/or not co-operative
- •Women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
研究组 & 干预措施
1
Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection.
干预措施: Immunotherapy with modified extract of Olea europaea pollen (Biological)
2
Placebo for subcutaneous injection.
干预措施: Placebo (Biological)
结局指标
主要结局
Symptoms and medication score
时间窗: 2 years
次要结局
- Visual Analog Scales (VAS)(2 years)
- Serology(2 years)
- Exhaled nitric oxide(2 years)
- Dose-response skin prick-test(2 years)
- Medication score(2 years)
- Rhinoconjunctivitis quality of life questionnaire(2 years)
- Symptoms score(2 years)
- Adverse event(2 years)