NCT01013116Unknown3 期
A Double-blind Placebo-controlled Trial to Evaluate Efficacy and Safety of Specific Subcutaneous Immunotherapy in Patients With Perennial Allergic Rhinitis Due to House Dust Mites
Roxall Medizin1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Symptom and medication score
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive history of perennial allergic rhinitis due to house dust mites
- •Positive screening skin prick test (wheal diameter > 3 mm)
- •Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- •Signed and dated patient´s Informed Consent,
排除标准
- •Previous immunotherapy with mite extracts within the last 3 years,
- •Simultaneous participation in other clinical trials,
- •Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- •Auto-immune disorders,
- •Severe chronic inflammatory diseases,
- •Malignancy,
- •Alcohol abuse,
- •Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
- •Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
结局指标
主要结局
Symptom and medication score
时间窗: 1 year
次要结局
- Safety of the treatment(1 year)
- Clinical global improvement(1 year)
- Quality of Life Questionnaire(1 year)
- Documentation of adverse events(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen ExtractsAllergic ConjunctivitisAllergic RhinitisNCT01012752Roxall Medizin150
已完成
4 期
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced AsthmaAllergic AsthmaNCT00492076ALK-Abelló A/S45
已完成
2 期
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic ArthritisArthritis, PsoriaticNCT02719171AbbVie185
进行中（未招募）
3 期
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical RemissionGiant Cell ArteritisNCT05380453Novartis Pharmaceuticals151
进行中（未招募）
2 期
Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19COVID-19NCT04990544Shanghai Zerun Biotechnology Co.,Ltd528