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    Clinical Trial Results:
    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) Compound: Bilastine

    Summary
    EudraCT number
    		 2010-019344-39
    Trial protocol
    		 DE  
    Global end of trial date
    26 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2021
    First version publication date
    27 Nov 2021
    Other versions
    Summary report(s)
    		 Final Report

    Trial information

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    Trial identification
    Sponsor protocol code
    BUCUM1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergie-Centrum-Charité
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Prof. Dr. M. Maurer, Department of Dermatology and Allergy Charité - Universitätsmedizin Berlin, marcus.maurer@charite.de
    Scientific contact
    Prof. Dr. M. Maurer, Department of Dermatology and Allergy Charité - Universitätsmedizin Berlin, marcus.maurer@charite.de
    Sponsor organisation name
    Allergie-Centrum-Charité
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Prof. Dr. med. M. Maurer, Department of Dermatology and Allergy Charité - Universitätsmedizin Berlin, marcus.maurer@charite.de
    Scientific contact
    Prof. Dr. med. M. Maurer, Department of Dermatology and Allergy Charité - Universitätsmedizin Berlin, marcus.maurer@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Aug 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of a standard dose (20 mg) and higher than standard doses of bilastine (40 mg and 80 mg) on symptom development during the induction of skin lesions in cold contact urticaria (CCU) patients challenged with defined temperatures using TEMPtest 3.0.
    Protection of trial subjects
    Bilastine encoded F-96221-BM1, 2-[4-(2-(4-(1-(2-ethoxyethyl)-1H-benzimidazol-2- yl)piperidin-1-yl)ethyl)phenyl]-2-methylpropionic acid, is a novel drug substance which has been developed by FAES FARMA for the treatment of the symptoms of allergic rhinoconjunctivitis and urticaria. It is a new H1 antagonist with no sedative side effects and no cardiotoxic effects. The target dose of bilastine is a tablet of 20 mg once daily. In a randomized double-blind placebo-controlled study with 525 patients it has been shown that bilastine 20 mg is effective and safe in reducing clinical symptoms in chronic spontaneous urticaria (12).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients included in this study will be subjected at the screening visit (V1) to a physical examination. If the diagnosis of CCU has not been confirmed in the past, an additional cold provocation test with 4°C will be performed us ing Temptest 3.0. At V2, patients will be tested for CCU symptom development.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Baseline
    Arm description
    		 -
    Arm type
    		 Baseline

    Investigational medicinal product name
    Bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets containing 20 mg bilastine.

    Number of subjects in period 1
    		Baseline
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Treatment 1-4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Treatment 1-4
    Arm description
    		 Patients will then be given 1) bilastine 40 mg daily or 2) placebo for 7 days according to the randomisation at V2. All patients will be told to start with the medication 1) or 2) after completion of a two-week washout-period. At the end of the 7-day treatment phase patients will return for V4 and again be tested for CCU symptom development. After another two-week washout-period patients will receive either 1) bilastine 40 mg daily or 2) placebo for 7 days (according to the randomization at V2). At the end of the 7-day treatment phase patients will return for V5 and again be tested for CCU symptom development. After yet another two-week washout-period patients will receive either 1) bilastine 80 mg daily or 2) bilastine 20 mg for 7 days (according to the randomization at V2). At the end of the 7-day treatment phase patients will return for V6 and again be tested for CCU symptom development.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sequence A: 20 mg 40 mg Placebo 80 mg Sequence B: 80 mg Placebo 40 mg 20 mg See Final report

    Number of subjects in period 2
    		Treatment 1-4
    Started
    20
    Completed
    20

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -
    Reporting group title
    Treatment 1-4
    Reporting group description
    		 Patients will then be given 1) bilastine 40 mg daily or 2) placebo for 7 days according to the randomisation at V2. All patients will be told to start with the medication 1) or 2) after completion of a two-week washout-period. At the end of the 7-day treatment phase patients will return for V4 and again be tested for CCU symptom development. After another two-week washout-period patients will receive either 1) bilastine 40 mg daily or 2) placebo for 7 days (according to the randomization at V2). At the end of the 7-day treatment phase patients will return for V5 and again be tested for CCU symptom development. After yet another two-week washout-period patients will receive either 1) bilastine 80 mg daily or 2) bilastine 20 mg for 7 days (according to the randomization at V2). At the end of the 7-day treatment phase patients will return for V6 and again be tested for CCU symptom development.

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint [1]
    End point description
    Sequence A: 20 mg, 40 mg, Placebo, 80 mg Sequence B: 80 mg, Placebo, 40 mg, 20 mg The endpoint value refers to bilastine 20mg as an example. For the other groups please see final report.
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See final report
    End point values
    		 Treatment 1-4
    Number of subjects analysed
    20 [2]
    Units: critical stimulation time thresholds (CS
        median (inter-quartile range (Q1-Q3))
    270 (157.5 to 300)
    Notes
    [2] - For example: Treatment group 20mg
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the whole trial. See final report
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See final report

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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