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    Clinical Trial Results:
    Biological standarization of allergic extracts of wild grasses: Phleum pratense, Lolium perenne, Poa pratensis y Dactylis glomerata and its mixture to determinate their biological activity, the In House Reference Preparation, measures in Histamine unit equivalents (HEP) in sensitized patients

    Summary
    EudraCT number
    		 2019-002644-24
    Trial protocol
    		 ES  
    Global end of trial date
    18 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2024
    First version publication date
    26 Dec 2024
    Other versions
    Summary report(s)
    		 Biological standarization of wild grasses

    Trial information

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    Trial identification
    Sponsor protocol code
    DIA-STA-11-01-19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Diater S.A.
    Sponsor organisation address
    Avda Gregorio Peces Barba, nº 2, Leganés - Madrid, Spain, 28024
    Public contact
    Medical Department, DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A., 34 9149660131419, departamento.medico@diater.com
    Scientific contact
    Medical Department, DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A., 34 9149660131419, departamento.medico@diater.com
    Sponsor organisation name
    Diater S.A.
    Sponsor organisation address
    Avda Gregorio Peces Barba, nº 2, Leganés - Madrid, Spain, 28024
    Public contact
    M. Munoz, M. Munoz, m.munoz@diater.com
    Scientific contact
    M. Munoz, M. Munoz, 34 914966013, m.munoz@diater.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
    14 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate in vivo the concentration of the allergenic extracts of wild grass pollen individually: Phleum pratense, Lolium perenne, Poa pratensis and Dactylis glomerata and their mixture that provoked a papule of a size equivalent to that produced by a solution of Histamine dihydrochloride at 10 mg/ml. And standardize the allergenic extracts in biological units.
    Protection of trial subjects
    Each potential subject was adequately informed of the aims, method, anticipated benefits and potential hazards of the study and the discomfort that it might entail. All of them were informed that they were free to participate in the study and stop their participation at any time. Participants had the opportunity to make all kind of questions about the study, and every subject confirmed his or her participation by filling in and signing the informed consent form. Written informed consent was obtained from each subjects prior to the performance of any study-specific procedures
    Background therapy
    		 NA
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2020
    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: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period (from the date of the first site ready to recruit to the date for the last patient entered into the study): October 2020 to February 2021. FPFV: 6 October 2020; LPLV: 18 February 2021 31 patients were enrolled.

    Pre-assignment
    Screening details
    		 The patients were allocated to the the following arm: EXPERIMENTAL GROUP: 31 patients who had been diagnosed positive for any of the allergens of the study by SPT Specific IgE positive received the allergenic extracts of wild grass pollen individually: Phleum pratense, Lolium perenne, Poa pratensis and Dactylis glomerata and their mixture.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 Patients who had been diagnosed positive for any of the allergens of the study by SPT Specific IgE positive
    Arm type
    		 Experimental

    Investigational medicinal product name
    Phleum pratense, Lolium perenne, Poa pratensis y Dactylis glomerata and its mixture
    Investigational medicinal product code
    V04CL
    Other name
    NA
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The test consisted the direct application of the four concentrations of the experimental allergenic extract (10 mg/ml; 1 mg/ml, 0.1 mg/ml and 0.01 mg/ml), together with the prick mixture of grasses (10 mg/ml, 1 mg/ml, 0.1 mg/ml and 0.01 mg/ml), the positive control of Histamine and the negative control of saline solution each allergen upon the skin and the performance of a Prick test

    Number of subjects in period 1
    		Treatment arm
    Started
    31
    Completed
    31

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 Patients who had been diagnosed positive for any of the allergens of the study by SPT Specific IgE positive

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Reporting group values ITT Population PP population Number of subjects [1] 31 Phleum pratense 31 26 Lolium perenne 31 21 Poa pratensis 31 26 Dactylis glomerata 31 27 Mixture of wild grasses 31 26

    Primary: To evaluate in vivo the concentration of allergic extracts of wild grasses individually and its mixture

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    End point title
    		 To evaluate in vivo the concentration of allergic extracts of wild grasses individually and its mixture
    End point description
    The Biological standarization consisted the direct application of the four concentrations of the experimental allergenic extracts (10 mg/ml; 1 mg/ml, 0.1 mg/ml and 0.01 mg/ml), together with the prick mixture of grasses (10 mg/ml, 1 mg/ml, 0.1 mg/ml and 0.01 mg/ml), the positive control of histamine and the negative control of saline solution upon the skin and the performance of a Prick test. Where the Prick test gave a positive response, the areas of erythema and papules, were measured (mm2). The skin tests were used to obtain the optimum allergen extract concentrations that provoked a response with the same wheal area to that obtained with the positive control solution of histamine dihydrochloride 10 mg/mL reaction.
    End point type
    Primary
    End point timeframe
    The primary variable was the area of papule (mm2) produced on the skin after application of the extracts
    End point values
    		 Treatment arm PP population
    Number of subjects analysed
    26
    26
    Units: mm2
        geometric mean (confidence interval 95%)
    0.85 (0 to 1)
    0.85 (0 to 1)
    Statistical analysis title
    		 Outcome
    Statistical analysis description
    Statistical analysis description: Validated and protected Microsoft Excel specifically designed for these analyses
    Comparison groups
    Treatment arm v PP population
    Number of subjects included in analysis
    52
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 > 95 [2]
    Method
    		 linear regression analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - The geometric mean of the areas of the papules (mm2) of each patient was calculated for each of the dilution series of each extract, as well as that of the positive control solution of histamine dihydrochloride 10 mg/mL. For each subject, a linear regression analysis was performed using the least squares method.
    [2] - NA

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From enrollment to 1 week after completion of the skin tests. The administration of a prick test is a very safe technique with few adverse events in the literature
    Adverse event reporting additional description
    NA
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    3
    Frequency threshold for reporting non-serious adverse events: 0%
    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: The administration of a prick test is a very safe technique with few adverse events in the literature

    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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