Cold Contact Urticaria
Conditions
Keywords
urticaria, bilastine
Brief summary
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.
Interventions
DRUGBilastine
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
Sponsors
Faes Farma, S.A.
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 months before and after participation in this study
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 | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 following administration of bilastine to patients with cold contact urticaria | up to 14 weeks | 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