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临床试验/NCT00824447
NCT00824447已完成2 期

A Randomised, DB, Plcb Controlled, Multicentre, Multinat. Phase II/III FU Study to Assess Longterm Efficacy and Safety of 3 Different Dose Regimens of Oralgen® GrassPollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

Artu Biologicals36 个研究点 分布在 7 个国家目标入组 356 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
356
试验地点
36
主要终点
Pollen Season Rhinoconjunctivitis Total Symptom Score

研究概览

简要总结

This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

详细描述

Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma.

Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment.

Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response.

Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.

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 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.
  • Patients who have given their written consent to participate in this study.
  • Patients who are willing to comply with the protocol and understand the information given.
  • Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
  • Negative urine pregnancy test if female at the end of the previous study.

排除标准

  • Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
  • Patients who were non-compliant during study AB
  • Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.

研究组 & 干预措施

Placebo control

Placebo Comparator

Placebo control

干预措施: placebo (Other)

Grass pollen extract, twice weekly

Active Comparator

Grass pollen extract, 9,500 BU, given twice weekly

干预措施: Oralgen (Drug)

Grass pollen extract daily

Active Comparator

Grass pollen extract, 9,500 BU, given daily

干预措施: Oralgen (Drug)

Increased dose of grass pollen extract

Active Comparator

Increased dose of grass pollen extract, 19,000 BU, given daily

干预措施: Oralgen (Drug)

结局指标

主要结局

Pollen Season Rhinoconjunctivitis Total Symptom Score

时间窗: site specific pollen season

次要结局

  • Rescue medication usage(one year)
  • Proportion of symptom-free days during the pollen season(one year)
  • Rhinoconjunctivitis QoL Questionnaire(one year)
  • Global evaluation of the efficacy by the patient(one year)
  • Local and systemic tolerability and other adverse events, labor(one year)

研究者

发起方
Artu Biologicals
申办方类型
Industry

研究点 (36)

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