Bilastine Updosing - Characterization of Underlying Mechanisms (BUCUM)

Charité University Medicine Berlin

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cold Contact Urticaria

Treatments

Drug: Bilastine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01271075

BUCUM 2010

2010-019344-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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