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Bilastine Updosing - Characterization of Underlying Mechanisms (BUCUM)

Primary Purpose

Cold Contact Urticaria

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bilastine
Bilastine
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold Contact Urticaria focused on measuring urticaria, bilastine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité-Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bilastine A

Bilastine B

Arm Description

A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg

B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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

Full Information

First Posted
December 30, 2010
Last Updated
May 30, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
Faes Farma, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01271075
Brief Title
Bilastine Updosing - Characterization of Underlying Mechanisms
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Faes Farma, S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Contact Urticaria
Keywords
urticaria, bilastine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilastine A
Arm Type
Active Comparator
Arm Description
A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg
Arm Title
Bilastine B
Arm Type
Active Comparator
Arm Description
B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
6 visits in 12-14 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70)
Title
Safety and tolerability following administration of bilastine to patients with cold contact urticaria
Description
Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting
Time Frame
up to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Maurer, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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