Cold contact urticaria
Conditions
Interventions
Product Name: Bilastine
Product Code: F-96221-BM1
Pharmaceutical Form: Tablet
CAS Number: 202189-78-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceut
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 month before and after participation in this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of a standard dose (20 mg) and higher than standard doses of bilastine (40 mg and 80 mg) on symptom development during the induction of skin lesions in cold contact urticaria (CCU) patients challenged with defined temperatures using TEMPtest 3.0. ;Secondary Objective: To assess the effects of a standard dose (20 mg) and higher than standard doses of bilastine (80 mg) on mast cell mediator release during the induction of skin lesions in CCU patients challenged with defined temperatures using TEMPtest 3.0. Mediator measurements will include histamine and mast cell-derived cytokines (e.g. IL-1, IL-6, IL-8, IL-13, TNF). To assess the safety and tolerability of bilastine. ;Primary end point(s): - 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). - Change in mast cell mediator release, including histamine and mast cell-derived cytokines (e.g. IL-1, IL-6, IL-8, IL-13, TNF) after standard dose treatment with bilastine (20 mg) compared to high dose bilastine (80 mg) and baseline. - Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting | — |
Countries
Germany
Outcome results
None listed