Bilastine Updosing - Characterization of Underlying Mechanisms (BUCUM)

This study has been completed.
Sponsor:
Collaborator:
Faes Farma, S.A.
Information provided by (Responsible Party):
Karoline Krause, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01271075
First received: December 30, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Cold Contact Urticaria
Drug: Bilastine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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 [ Time Frame: 6 visits in 12-14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70) ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting


Enrollment: 20
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271075

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

No publications provided

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
Study First Received: December 30, 2010
Last Updated: May 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
urticaria
bilastine

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014