Bilastine Updosing - Characterization of Underlying Mechanisms (BUCUM)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Cold Contact Urticaria	Drug: Bilastine	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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)
Study Start Date :	September 2010
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Bilastine A; A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg	Drug: Bilastine; Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
Active Comparator: Bilastine B; B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg	Drug: Bilastine; Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: 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 Outcome Measures :

1. 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 [ Time Frame: 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.
2. Safety and tolerability following administration of bilastine to patients with cold contact urticaria [ Time Frame: up to 14 weeks ]
   Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

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Locations

Germany
Charité-Universitätsmedizin Berlin
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Faes Farma, S.A.

Investigators

Principal Investigator:	Marcus Maurer, MD	Charite University, Berlin, Germany

More Information

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Responsible Party:	Karoline Krause, Karoline Krause, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01271075 History of Changes
Other Study ID Numbers:	BUCUM 2010; 2010-019344-39 ( EudraCT Number )
First Posted:	January 6, 2011
Last Update Posted:	May 31, 2012
Last Verified:	May 2012

Keywords provided by Karoline Krause, Charite University, Berlin, Germany:

urticaria; bilastine

Additional relevant MeSH terms:

Urticaria; Skin Diseases, Vascular; Skin Diseases	Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases