Twin SUBLIVAC® Grasses Clinical Efficacy Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 59
- 主要终点
- Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
研究概览
简要总结
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
详细描述
Indication under study: IgE mediated allergic disorders triggered by grass pollen.
Number of centres: approximately 50.
Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based on the outcome the study will be stopped or continued for another season.
Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without mild asthma (FEV1 > 70%) related to grass pollen, age 12 years or older.
Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with allergic rhinoconjunctivitis with or without mild asthma FEV1 ≥ 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the two previous years)
- •A positive skin prick test (>3 mm) for early flowering treesgrasses and specific serum IgE-test(>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poa pratensis).
排除标准
- •A positive SPT for perennial allergens of house dust mite
- •Allergy to any of the excipients
- •Symptoms related to concomitant sensitisation to perennial allergens of pets
- •Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
- •Use of symptomatic medication for more than three episodes and/or longer than three days outside the tree- or grass pollen season
- •Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
- •Inflammation and infection of the target organ
- •Severe atopic dermatitis requiring systemic immuno-suppressive medication
- •Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
- •History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
- •A positive pregnancy test, lactation or inadequate contraceptive measures Alcohol- or drug abuse
- •Lack of co-operation or severe psychological disorders
研究组 & 干预措施
1
SUBLIVAC® Grasses treatment
干预措施: SUBLIVAC® Grasses/Placebo treatment (Drug)
1
SUBLIVAC® Grasses treatment
干预措施: SUBLIVAC® Grasses treatment (Drug)
2
Placebo treatment
干预措施: SUBLIVAC® Grasses/Placebo treatment (Drug)
2
Placebo treatment
干预措施: Placebo treatment (Drug)
结局指标
主要结局
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
时间窗: June, July, August 2007
次要结局
- CIS derived variables(June, July and August 2007)
- RQLQ, quantitative skin prick test(Pollen season 2006 and 2007)
- oral allergy syndrome(October 2006 until September 2007)
- mast-cell serum tryptase(6 months therapy)
- specific immunoglobulins (IgE and IgG).(6 months therapy)