Bilastine Updosing - Characterization of Underlying Mechanisms

Cold Contact Urticaria Clinical Trial

— BUCUM  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271075
• Other study ID #: BUCUM 2010
• Secondary ID: 2010-019344-39
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 30, 2010
• Last updated: May 30, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cold Contact Urticaria
• Urticaria

Intervention

Drug:
• Bilastine
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
• Bilastine
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Faes Farma, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	6 visits in 12-14 weeks	No
Secondary	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	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.	Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70)	No
Secondary	Safety and tolerability following administration of bilastine to patients with cold contact urticaria	Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting	up to 14 weeks	Yes