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    Clinical Trial Results:
    Biological standarization of Cupressus arizonica allergen extract to determine the biological activity in histamine equivalent units (HEP)

    Summary
    EudraCT number
    		 2013-001309-98
    Trial protocol
    		 ES  
    Global end of trial date
    24 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2022
    First version publication date
    15 May 2022
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    608-PR-PRI-199
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02512653
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios LETI S.L.
    Sponsor organisation address
    c/Sol nº 5, Madrid, Spain, 28760
    Public contact
    Medical Department, LABORATORIOS LETI, S.L.Unipersonal, 34 917711790, clinicalresearch@leti.com
    Scientific contact
    Medical Department, LABORATORIOS LETI, S.L.Unipersonal, 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
    06 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2015
    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 Cupressus arizonica allergen extract that elictis a wheal size equivalent to that of 10 mg/ml histamine dyhidrochloride solution.
    Protection of trial subjects
    According to ICH-GCP, patients had to give their consent to participate in the clinical trial, only after having been fully informed by the investigator of the nature, significance and implications thereof.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 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
    Spain: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Clinical history of respiratory allergy (rhinitis and / or rhinoconjunctivitis and / or asthma) against Cupressus arizonica.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allergen extract of Cupressus arizonica
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1, 5, 10 and 15 mg/ml

    Investigational medicinal product name
    Histamine Diclorhidrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/ml

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Not applicable

    Number of subjects in period 1
    		Experimental
    Started
    33
    Completed
    20
    Not completed
    13
         Protocol deviation
    13

    Baseline characteristics

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    End points

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

    Primary: Efficacy

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    End point title
    		 Efficacy [1]
    End point description
    End point type
    Primary
    End point timeframe
    The total duration of the study for a patient was approximately 30 minutes plus at least 30 minutes, under observation in the medical rooms, after the application of the Titrated Skin Prick test.
    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: Statistical results were not relevant for publish
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: Size
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the clinical trial, adverse events could be spontaneously reported or elicited during open- ended questioning, examination, or evaluation of the patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    nk
    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: No adverse events were reported in the 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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