NCT02277483Unknown4 期
Efficacy and Safety of LAIS® Mites Sublingual Tablets in Patients Aged Over 60 Years Suffering From House Dust Mite-induced Allergic Rhino-conjunctivitis With/Without Asthma
Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Total combined score (TCS)
研究概览
简要总结
Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM) induced allergic rhino-conjunctivitis with/without asthma.
详细描述
The Total combined score (TCS), taking into account the rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS), in the maximum expected mites exposition period (V4-V5) For the RTSS and the RTMS, the daily values as determined by the patients in their diary card are collected during the observation period over 30 days. Then, the mean daily scores during that period are calculated for both parameters.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients aged 60 years or more with a history of at least two years of house dust mite (HDM) induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without mild to moderate controlled asthma upon exposure to house dust mite [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA)
- •Clinically relevant sensitization to mites.
- •Positive clinical history of allergy due to house dust mite (HDM), proven by- The majority of perennial clinical symptoms appearing mostly related to indoor mites allergens
- •Specific Immunoglobulin E reactivity to mites allergens (ImmunoCAP>0.35 Ku/L)
- •Positive skin prick test (wheal diameter> 3mm, negative control < 2mm)
- •Retrospective Total Symptom Score (RRTSS) referred to the previous winter season greater than or equal to 8
- •Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication
- •Signed and dated patient's Informed Consent
排除标准
- •Simultaneous participation in other clinical trials
- •Previous immunotherapy with mite allergens or cross reacting allergens within the last 5 years
- •Ongoing immunotherapy with any allergen
- •Patients being in any relationship or dependency with the sponsor and/or investigator
- •Other reasons contra-indicating an inclusion into the trial according to the investigator's estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
- •Predominant seasonal allergic rhinitis
- •Patients with clinically relevant sensitization to seasonal aero-allergens occurring during the study period may not be included. Also patients with clinically relevant sensitization to perennial allergens like animal dander may not be included
- •Uncontrolled asthma
- •Chronic asthma or emphysema, particularly with a forced expiratory volume <70% of the predicted value and /or <70% of the individual optimum value
- •Infections of the oral cavity with severe symptoms
- •Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption
- •Active tuberculosis
- •Generally inflammatory as well as severe acute and chronic inflammatory diseases
- •Irreversible secondary disorders at the target organ (e.g. emphysema, bronchiectasis)
- •Immune deficiency (for example induced by immunosuppressive drugs)
- •Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well rheumatic diseases, based on an autoimmune mechanism,
- •Alcohol abuse as well as drug and / or medication abuse
- •Patients treated with contra-indicated drugs
- •Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
- •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
- •Completed or ongoing treatment with anti-Specific Immunoglobulin E-antibody
- •Uncontrolled asthma according to GINA guideline criteria
研究组 & 干预措施
active treatment
Active Comparator
LAIS® Mites Sublingual tablets + rescue medication
干预措施: LAIS® (Drug)
结局指标
主要结局
Total combined score (TCS)
时间窗: up to 48 weeks
TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)
次要结局
- sublingual immunotherapy(up to 48weeks)
研究者
Hae-Sim Park
professor, Department alleric internal medicine
Ajou University School of Medicine
研究点 (1)
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