A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 35
- 主要终点
- Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
研究概览
简要总结
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
详细描述
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female aged 18-50
- •patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
- •Positive skin prick test and IgE value of at least Class 2+
- •RTSS of greater or equal to 14 during pollen season prior tot the start of the study
- •Patients must be in general good health
- •Patients with normal spirometry
- •Informed consent given and willing to comply with the protocol
- •Female patients are eligible if they use an accepted contraceptive method
- •Negative urine pregnancy test if female
排除标准
- •Pregnancy, breast feeding
- •Asthma requiring treatment other than beta-2 inhaled agonists
- •patients who have taken oral steroids within 12 weeks before screening visit
- •patients who have received desensitisation treatment for grass pollen
- •treatment by immunotherapy with any other allergen within the previous 5 years
- •patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
- •patients at risk of non-compliance
- •participation in any other clinical study within the previous 3 months
- •patients with a past or current disease, which may affect participation in or outcome of this study.
- •patients treated with beta-blockers or under continuous corticotherapy
- •allergic sensitivity to epithelial allergens the patients is exposed to
- •positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
- •intention to subject the patient to surgery of the nasal cavity during current study
- •Usual contraindications of immunotherapy
- •a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season
研究组 & 干预措施
grass pollen extract twice weekly
Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.
干预措施: Oralgen (Drug)
Grass pollen extract, daily
Grass pollen immunotherapy, 9,500 BU, given daily
干预措施: Oralgen (Drug)
Increased dose of grass pollen extract
Increased dose of grass pollen immunotherapy, 19,000 BU, given daily
干预措施: Oralgen (Drug)
Placebo control
Patients randomized to placebo will receive placebo daily.
干预措施: grass pollen extract (Drug)
结局指标
主要结局
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
时间窗: One year
次要结局
- Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.(one year)