NCT00660452已完成3 期
A Randomised, Double-blind, Placebo-controlled, Multi-centre, Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Chinese Asthmatic Patients Allergic to House-dust Mites
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo
研究概览
简要总结
A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 16 to 50 years (inclusive).
- •House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
- •Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
- •Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day.
排除标准
- •Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
- •Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
- •FEV1 < 70% of predicted value at Visit
- •Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
- •Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
研究组 & 干预措施
1
Active Comparator
360 active patients with house dust mites related asthma with or without allergic rhinitis
干预措施: Staloral (Drug)
2
Placebo Comparator
180 patients in the placebo group with house -dust mites related asthma with or without allergic rhinitis.
干预措施: Staloral (Drug)
结局指标
主要结局
determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo
时间窗: September 2009
次要结局
- Daily dose of steroids at the endpoint Number of asthma exacerbations Asthma Control Questionnaire(ACQ)score Asthma Quality of Life Questionnaire (AQLQ) score Lung Function Parameters ( FEV1; FEF 25-75 %; PEF) Allergic rhinitis g(September 2009)
研究者
研究点 (1)
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