NCT00537342已完成3 期
Prospective, Randomised, Double Blind, Placebo Controlled Study of Treatment With Sublingual Immunotherapy of Depigmented and Polymerised Allergen Extract of O. Europaea in Two Groups of Patients With Allergic Rhinitis /Rhinoconjunctivitis
Laboratorios Leti, S.L.2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Symptom score
研究概览
简要总结
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis
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
- •Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
- •Patients of both gender > 18 years old
- •Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2)
- •Specific IgE to Olea europaea
- •Written informed consent
排除标准
- •Use of immunotherapy during the last four years.
- •Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- •Treatment with ß-blockers
- •Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- •Patients suffering from immune deficiencies
- •Patients with serious psychiatric / psychological disturbances
- •In addition, the following was considered as exclusion criteria:
- •Pregnant or/ in lactation patients
- •Patients aspirin intolerance
结局指标
主要结局
Symptom score
时间窗: 1 year
次要结局
- Dose-response skin prick-test(1 year)
- Medication score(1 year)
- Rhinoconjunctivitis quality of life questionnaire(1 year)
- Analogical visual scale(1 year)
- Serology(1 year)
- Record of adverse events(1 year)
研究者
研究点 (2)
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