A Prospective Pilot Study to Observe the Effects of Cat Exposure in an Allergen Exposure Chamber (AEC) in Cat Allergic Patients Taking a Food for Special Medical Purposes (holoBLG) for 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- TSS
研究概览
简要总结
The aim of the study is to investigate the antigen-unspecific effect of a 3 months supplementation with a food for special medical purposes (FSMP) in form of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in patients with allergic rhinoconjunctivitis caused by cat (hair/dander) and the associated symptoms (symptom type and severity) during exposure to cat allergen in an Allergen Exposure Chamber (AEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 1 year of clinically relevant cat allergy
- •positive SPT (wheal >3mm)
- •Positive NPT
- •Increase in TSS >3 during the 1st exposure in the AEC
- •Verbal and written consent
排除标准
- •subjects <18 years
- •subjects taking immunosuppressive drugs such as systemic corticosteroids, cyclosporine, etc.
- •subjects who have received or are currently receiving sublingual or subcutaneous immunotherapy (SLIT/SCIT) for cat allergy in the last 2 years prior to V0
- •clinically relevant overreactions to the ingredients of holoBLG, in particular subjects with a milk protein allergy or pronounced lactose intolerance
- •subjects with severe asthma and/or a history of uncontrolled asthmatic attacks in the last three months before the selection process (GINA 4 and 5).
- •subjects with an FEV1 <70% (predicted value) prior to exposure in the AEC
- •Lack of verbal and written informed consent
- •subjects who are not proficient in the German language
- •History of serious chronic medical illness and/or any condition for which the local investigator believes that participation in the study could pose a risk to the individual
- •Pregnancy and lactation
- •Contraindications and/or history of adrenaline intolerance and/or emergency medications
- •Concurrent use of anti-allergic medications and/or inadequate washout period of these anti-allergic medications prior to the selection process and exposure in the exposure chamber
- •TSS ≥ 6 at t0 of first exposure in the AEC
- •Subjects who have a history of ingestion of holoBLG
结局指标
主要结局
TSS
时间窗: After 120 minutes of allergen challenge
Total Symptom Score in response to cat exposure in an AEC at baseline versus final AEC exposure. The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening), 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus), and 2 other symptoms (itchy palate, and itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TSS of 42.
次要结局
- NPT(up to 3 months following first AEC)
- TBSS(Up to 120 minutes following allergen challenge)
- FEV1/FVC(Recorded at time zero (0) and 120 minutes)
- PNIF(Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes)
- FEV1(Recorded at time zero (0) and 120 minutes)
- VAS(Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes)
- PEF(Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes)
- TOSS(Up to 120 minutes following allergen challenge)
- TNSS(Up to 120 minutes following allergen challenge)
- TESS(Up to 120 minutes following allergen challenge)
- Adverse events with regards to the allergen exposure(up to 24 hours after AEC exposure)