Double-blind, Triple Cross-over, Placebo-controlled Study to Assess the Efficacy, Mechanisms, and Safety of Treatment With Bilastine 20 mg, 40 mg and 80 mg in Cold Contact Urticaria (CCU)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The effects of a standard dose (20 mg) and higher than standard doses of bilastine (40 mg and 80 mg) on symptom development in CCU patients
研究概览
简要总结
This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy, mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold contact urticaria (CCU).
Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49, and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Informed consent signed and dated
- •Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
- •Outpatients with CCU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- •Age above 18 years.
- •No participation in other clinical trials 1 months before and after participation in this study
排除标准
- •Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz)
- •The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- •The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
- •History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- •History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
- •ECG alterations of repolarisation (QTc prolongations > 450ms)
- •Blood pressure >180/100 mmHg and/or heart rate >100/min.
- •Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value)
- •History of adverse reactions to bilastine or known hypersensitivity to bilastine or its ingredients
- •Presence of active cancer which requires chemotherapy or radiation therapy
- •Presence of alcohol abuse or drug addiction
- •Intake of oral corticosteroids within 14 days prior to screening visit
- •Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit
- •Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit
- •Pregnancy or breast-feeding
研究组 & 干预措施
Bilastine A
A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg
干预措施: Bilastine (Drug)
Bilastine B
B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg
干预措施: Bilastine (Drug)
结局指标
主要结局
The effects of a standard dose (20 mg) and higher than standard doses of bilastine (40 mg and 80 mg) on symptom development in CCU patients
时间窗: 6 visits in 12-14 weeks
Change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg).
次要结局
- The effects of a standard dose (20 mg) and higher than standard doses of bilastine (80 mg) on mast cell mediator release in CCU patients(Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70))
- Safety and tolerability following administration of bilastine to patients with cold contact urticaria(up to 14 weeks)
研究者
Karoline Krause
Karoline Krause, MD
Charite University, Berlin, Germany