A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 374
- 试验地点
- 60
- 主要终点
- Difference between active and placebo-group based on combined RTSS and RMS score
研究概览
简要总结
This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.
详细描述
Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons
- •positive skin prick test RRTSS greater or equal to 12 during the 2008 season
- •signed informed consent
排除标准
- •positive skin prick test for other environmental allergens and suffering from serious allergic symptoms
- •clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season
- •clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed
- •lacking of good health
- •abnormal spirometry
- •lower respiratory tract infection
- •asthma requiring treatment other than beta-2 agonists
- •oral steroids within 12 weeks before screening
- •regular contraindications for use of immunotherapy
研究组 & 干预措施
Grass pollen extract
Subjects will receive 19.000 BU grass pollen extract daily sublingually
干预措施: Oralgen (Drug)
Placebo control
Subjects will receive matching placebo control daily sublingually
干预措施: placebo control (Other)
结局指标
主要结局
Difference between active and placebo-group based on combined RTSS and RMS score
时间窗: third season
次要结局
- Difference between active and placebo based on RTSS score(third season)