NCT02245360已完成3 期
A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 107
- 试验地点
- 15
- 主要终点
- The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
研究概览
简要总结
To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
- •Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
- •Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
- •If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
- •Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))
排除标准
- •Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- •Clinical history of uncontrolled asthma within 3 months prior to the screening visit
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: placebo (Drug)
Grass tablet 75,000 SQ-T
Experimental
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
干预措施: Phleum pratense grass pollen allergen extract (Drug)
结局指标
主要结局
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
时间窗: baseline versus end of treatment (approx. 60 days)
measurement of IgG4 in serum
次要结局
- Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment(baseline versus end of treatment (approx. 60 days))
研究者
研究点 (15)
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