Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- cumulative score of allergic symptoms of the lips evaluated by the patient
研究概览
简要总结
The goal of this multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms.
详细描述
The immune system of humans can show an overreaction to proteins from the environment (allergic reaction). Triggers of these allergic reactions may be e.g. pollen, dust mites, mold or animal hair. Common allergic symptoms include itchy, stuffy, runny nose, sneezing, itchy and watery eyes and respiratory complaints. Allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease. An example of such immunotherapies is the sublingual immunotherapy (SLIT). During SLIT, side effects may occur such as local oropharyngeal reactions, e.g. manifesting as itching, swelling or irritation.
The current study aims to investigate the efficacy of Ectoin Lozenges (EHT02) in patients suffering from oropharyngeal allergic symptoms. The symptoms are induced by SLIT.
Patients are dedicated to one of three groups: a) preventive application of Ectoin Lozenges before SLIT-initiation, b) therapeutic application of Ectoin Lozenges after SLIT-initiation or c) control: SLIT-initiation without application of Ectoin Lozenges.
The symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after SLIT-initiation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •initiation of a SLIT
- •minimum age of 18 years
- •written consent of the patient
排除标准
- •Surgical Procedures in the mouth and throat region prior to the study
- •patients with known intolerance to one of the substances used
- •pregnant or breast-feeding women
研究组 & 干预措施
Preventive application of EHT02
application of one Ectoin Lozenge before SLIT-initiation
干预措施: Medical Device: Ectoin Lozenge (Device)
Therapeutic application of EHT02
application of one Ectoine Lozenge after SLIT-initiation
干预措施: Medical Device: Ectoin Lozenge (Device)
No application of EHT02
SLIT-Initiation without Ectoin Lozenge
结局指标
主要结局
cumulative score of allergic symptoms of the lips evaluated by the patient
时间窗: about 30 minutes after SLIT-initiation
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the lips (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
cumulative score of allergic symptoms of the mouth evaluated by the patient
时间窗: about 30 minutes after SLIT-initiation
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the mouth (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
cumulative score of allergic symptoms of the throat evaluated by the patient
时间窗: about 30 minutes after SLIT-initiation
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the throat (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
次要结局
- Incidence of adverse events/serious adverse events(through study visit (participation encompasses 1 visit of approx. 60 min duration))