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    Clinical Trial Results:
    Biological standardization of Alternaria alternata allergen extract to determine the biological activity in histamine equivalent units (HEP).

    Summary
    EudraCT number
    		 2013-001308-13
    Trial protocol
    		 ES  
    Global end of trial date
    26 Nov 2014

    Results information
    Results version number
    		 v1
    This version publication date
    15 May 2022
    First version publication date
    15 May 2022
    Other versions
    		 v2
    Summary report(s)
    		 Synopsis Final Report

    Trial information

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    Trial identification
    Sponsor protocol code
    301-PR-PRI-198
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LABORATORIOS LETI S.L.U
    Sponsor organisation address
    c/ SOL, TRES CANTOS, MADRID, Spain, 28760
    Public contact
    Departamento Médico, LABORATORIOS LETI S.L.U, +34 917711790, clinicalresearch@leti.com
    Scientific contact
    Departamento Médico, LABORATORIOS LETI S.L.U, +34 917711790, clinicalresearch@leti.com
    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
    24 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Feb 2014
    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
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 sUBJECTS WITH RINOCONJUNTIVIS

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alternaria alternata allergen extract
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Four ten-fold concentrations of Alternaria alternata allergen extract (10, 1, 0.1 and 0.01 mg/ml).

    Number of subjects in period 1
    		Experimental
    Started
    30
    Completed
    26
    Not completed
    4
         Consent withdrawn by subject
    1
         Protocol deviation
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 30 30
    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)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Primary: The primary efficacy endpoint was the wheal size area (mm2) on the skin at the site of the puncture during the immediate phase

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    End point title
    		 The primary efficacy endpoint was the wheal size area (mm2) on the skin at the site of the puncture during the immediate phase [1]
    End point description
    End point type
    Primary
    End point timeframe
    The clinical trial consisted of 1 or 2 site visits per patient of approximately 30 minutes, depending on the possibility to assess eligibility criteria during visit 1.
    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: The information regarding statistical analyses provide confidential information not available to be shared according to company disclosure.
    End point values
    		 Experimental
    Number of subjects analysed
    26
    Units: mm2
        geometric mean (standard deviation)
    4.02 ( 8.25 )
    Attachments
    		 Untitled (Filename: CT 198 - CSR_Alternaria alternata_Final_Synopsis.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    One year 2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    5
    Frequency threshold for reporting non-serious adverse events: 1%
    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: No Adverse events were reported in this clinical trial

    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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