Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effects of Bilastine on F1 Simulator driving performance in patients affected by allergic rhinitis and/or urticaria

    Summary
    EudraCT number
    		 2015-001313-26
    Trial protocol
    		 IT  
    Global end of trial date
    21 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2017
    First version publication date
    22 Feb 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MEIN/14/Bil-ARU/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02576041
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini International Operations Luxembourg SA
    Sponsor organisation address
    1, Avenue de la Gare, Luxembourg, Luxembourg,
    Public contact
    Medical Director, Medical Scientific Management, Menarini International Operations Luxembourg S.A., +352264976, +352 264976,
    Scientific contact
    Clinical Operation Manager, Menarini Corporate Medical Department, A. Menarini Industrie Farmaceutiche Riunite, +3905556801, +39 05556801,
    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
    21 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the attention level (wakefulness) by assessing the patients’ driving performance (driving ability in stress condition) using the F1 high-speed simulator, following treatment with Bilastine; • To assess the reactivity level by assessing the patients’ psychomotor reactivity during the driving performance test (using the F1-high speed simulator), following treatment with Bilastine.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment details: Total recruitment period (first patient in to last patient in): 26.10.2015 - 24.11.2015

    Pre-assignment
    Screening details
    		 Screening was performed in 2 separate sections, at hospital site (H) and at the simulator (S) centre, divided by 14 days maximum. A total of 19 patients were screened and only one failed screening and was not randomized.

    Pre-assignment period milestones
    Number of subjects started
    		 19 [1]
    Number of subjects completed
    		 18

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignement period is the screening period. 19 patients were enrolled and one patient was excluded after the screening visit to evaluate the ability to complete the test without discomfort (V1-S), as the patient did not tollerate to use the simulator.
    Period 1
    Period 1 title
    Placebo (wash-out)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 This is a single arm design study, with 18 patients enrolled to a Placebo wash out period (7+3 days) followed by a Bilastine active treatment period (7+3 days).
    Arm type
    		 Single arm placebo/active treatment

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the wash out period (V0-V1) Placebo was administerd at the dose of one tablet once daily. The tablets should have been administered in the morning at empty stomach at least one hour before breakfast or two hours after intake of food or fruit juice. It was recommended to take the daily dose in one single intake

    Investigational medicinal product name
    Bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the active treatment period (following wash out) Bilastine was administerd at the dose of one tablet once daily. The tablets should have been administered in the morning at empty stomach at least one hour before breakfast or two hours after intake of food or fruit juice. It was recommended to take the daily dose in one single intake. At the day of Visit V2S (visit at the simulator centre), bilastine should have been taken approximatively 1 and 1/2 hours before the driving test.

    Number of subjects in period 1
    		Single Arm
    Started
    18
    Completed
    18
    Period 2
    Period 2 title
    Bilastine (Active Treatment)
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 This is a single arm design study, with 18 patients enrolled to a Placebo wash out period (7+3 days) followed by a Bilastine active treatment period (7+3 days).
    Arm type
    		 Single arm placebo/active treatment

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the wash out period (V0-V1) Placebo was administerd at the dose of one tablet once daily. The tablets should have been administered in the morning at empty stomach at least one hour before breakfast or two hours after intake of food or fruit juice. It was recommended to take the daily dose in one single intake

    Investigational medicinal product name
    Bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the active treatment period (following wash out) Bilastine was administerd at the dose of one tablet once daily. The tablets should have been administered in the morning at empty stomach at least one hour before breakfast or two hours after intake of food or fruit juice. It was recommended to take the daily dose in one single intake. At the day of Visit V2S (visit at the simulator centre), bilastine should have been taken approximatively 1 and 1/2 hours before the driving test.

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the wash-out period were patient have taken placebo and not the baseline period with active treatment with Bilastine.
    Number of subjects in period 2
    		Single Arm
    Started
    18
    Completed
    18

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Bilastine (Active Treatment)
    Reporting group description
    		 18 patients who performed a F1-high speed-driving-simulation test before (V1) and after a 7 (+3) days of Bilastine treatment (V2).

    Reporting group values
    		 Bilastine (Active Treatment) Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adults
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.4 ± 7.3 -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 10 10
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subject who received at least one dose of placebo

    Subject analysis set title
    Safety Population (SP)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of the study drug Bilastine

    Subject analysis set title
    Intention to Treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all subjects who received at least one dose of the study drug Bilastine and who completed all the study procedures

    Subject analysis set title
    Per Protocol Population (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the ITT population who did not present any major protocol violation

    Subject analysis sets values
    		 Full Analysis Set (FAS) Safety Population (SP) Intention to Treat (ITT) Per Protocol Population (PP)
    Number of subjects
    18
    18
    18
    18
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    18
    18
    18
    18
        From 65-84 years
        85 years and over
        Adults
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.4 ± 7.3
    38.4 ± 7.3
    38.4 ± 7.3
    38.4 ± 7.3
    Gender categorical
    Units: Subjects
        Female
    8
    8
    8
    8
        Male
    10
    10
    10
    10

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 This is a single arm design study, with 18 patients enrolled to a Placebo wash out period (7+3 days) followed by a Bilastine active treatment period (7+3 days).
    Reporting group title
    Single Arm
    Reporting group description
    		 This is a single arm design study, with 18 patients enrolled to a Placebo wash out period (7+3 days) followed by a Bilastine active treatment period (7+3 days).

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subject who received at least one dose of placebo

    Subject analysis set title
    Safety Population (SP)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of the study drug Bilastine

    Subject analysis set title
    Intention to Treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all subjects who received at least one dose of the study drug Bilastine and who completed all the study procedures

    Subject analysis set title
    Per Protocol Population (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the ITT population who did not present any major protocol violation

    Primary: Standard deviation Lateral Position (SDLP)

    		 Close Top of page
    End point title
    		 Standard deviation Lateral Position (SDLP)
    End point description
    SDLP (mainly assessing attention capacities) is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.
    End point type
    Primary
    End point timeframe
    7+3 days of active treatment (Bilastine)
    End point values
    		 Single Arm Single Arm
    Number of subjects analysed
    18
    18
    Units: meters
        arithmetic mean (standard deviation)
    0.15 ± 0.07
    0.11 ± 0.04
    Statistical analysis title
    		 SDLP statistical analysis
    Statistical analysis description
    The t-test for paired data was used to evaluate the differences of performances between the wash-out period of 7(+3) days with placebo intake (V1-S) and the active treatment period of 7(+3) days with Bilastine 20 mg intake (V2S) for every efficacy endpoints.
    Comparison groups
    Single Arm v Single Arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.002
    Method
    		 paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.041
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.064
         upper limit
    		 -0.017
    Variability estimate
    Standard deviation
    Dispersion value
    0.047
    Notes
    [1] - If the assumption on data collected needed to use a paired t-test were not meet, the correspondent non-parametric test (Wilcoxon's test) was applied.

    Secondary: Maintenance of costant speed

    		 Close Top of page
    End point title
    		 Maintenance of costant speed
    End point description
    Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.
    End point type
    Secondary
    End point timeframe
    7+3 days of active treatment
    End point values
    		 Single Arm Single Arm
    Number of subjects analysed
    18
    18
    Units: Km/h
        arithmetic mean (standard deviation)
    5.26 ± 3.36
    3.87 ± 2.03
    Statistical analysis title
    		 Maintenance of constant speed statistical analysis
    Statistical analysis description
    The t-test for paired data was used to evaluate the differences of performances between the wash-out period of 7(+3) days with placebo intake (V1-S) and the active treatment period of 7(+3) days with Bilastine 20 mg intake (V2S) for every efficacy endpoints.
    Comparison groups
    Single Arm v Single Arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 = 0.0639
    Method
    		 paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.397
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.884
         upper limit
    		 0.09
    Variability estimate
    Standard deviation
    Dispersion value
    2.991
    Notes
    [2] - If the assumption on data collected needed to use a paired t-test were not meet, the correspondent non-parametric test (Wilcoxon's test) was applied.

    Secondary: Time to reaction

    		 Close Top of page
    End point title
    		 Time to reaction
    End point description
    During the test, at different times, the patient was requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions was registered.
    End point type
    Secondary
    End point timeframe
    7+3 days of active treatment (Bilastine)
    End point values
    		 Single Arm Single Arm
    Number of subjects analysed
    18
    18
    Units: msec
    arithmetic mean (standard deviation)
        Time reaction to Button A
    695 ± 120
    660 ± 167
        Time reaction to button B
    662 ± 144
    644 ± 105
    Statistical analysis title
    		 Time reaction to Button A statistical analysis
    Statistical analysis description
    The t-test for paired data was used to evaluate the differences of performances between the wash-out period of 7(+3) days with placebo intake (V1-S) and the active treatment period of 7(+3) days with Bilastine 20 mg intake (V2S) for every efficacy endpoints.
    Comparison groups
    Single Arm v Single Arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    P-value
    		 = 0.1446
    Method
    		 paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -34.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -82.1
         upper limit
    		 13.1
    Variability estimate
    Standard deviation
    Dispersion value
    95.71
    Notes
    [3] - If the assumption on data collected needed to use paired t-test were not meet, the correspondent non parametric test (Wilcoxon's test) was applied.
    Statistical analysis title
    		 Time reaction to Button B statistical analysys
    Statistical analysis description
    The t-test for paired data was used to evaluate the differences of performances between the wash-out period of 7(+3) days with placebo intake (V1-S) and the active treatment period of 7(+3) days with Bilastine 20 mg intake (V2S) for every efficacy endpoints.
    Comparison groups
    Single Arm v Single Arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    P-value
    		 = 0.259
    Method
    		 paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.21
         upper limit
    		 14.72
    Variability estimate
    Standard deviation
    Dispersion value
    66.28
    Notes
    [4] - If the assumption on data collected needed to use paired t-test were not meet, the correspondent non parametric test (Wilcoxon's test) was applied.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are recorded at each visit from screening visit V-1 (-21 days) to visit 2 at the end of the study active treatment period (15+3 days).
    Adverse event reporting additional description
    At each visit the Investigator assessed any occurring subjective or objective AE. Adverse events communicated by the patient or by the patients relatives or delegates through phone calls, letters or emails were also recorded
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 is the only arm, placebo and then bilastine

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 18 (100.00%)
    Investigations
    Laboratory test abnormal
         subjects affected / exposed
    16 / 18 (88.89%)
         occurrences all number
    16
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood alkaline phosphatase
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Blood chloride decreased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Blood potassium decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eosinophil count decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eosinophil count increased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Globulins decreased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Haemoglobin urine present
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Laboratory test
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    pH urine decreased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Specific gravity urine abnormal
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jul 2015
    This Protocol Amendment was implemented to add changes requested by Italian Medicines Agency (AIFA) and Ethic Committees. Main change was to leave as the only Primary End-Point the "Standard Deviation Lateral Position - SDLP" and to move to Secondary End-Point the "Maintainance of costant speed". Other changes made were : * Introduction of a more detailed rational of using the driving simulator in patients or in healthy volunteers to asses the effects of the pharmacological treatments and to justify why and how it has been used in this clinical trial. *Implementation of the justification of sample size of 18 patients.

    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.
    Note that due to technical limits in the portal the statistical analysis reports 36 patients included in the analysis and not 18 as they effectively are. 36 are indeed the 18 data collected before and the 18 after active treatment intake.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 27 03:38:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA