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    Clinical Trial Results:
    Open multicenter clinical trial to confirm the maximum no reactive dose of allergoid of polymerized Dermatophagoides pteronyssinus, in patients with allergic rhinoconjunctivitis or mild or moderate ashtma, who are sensitive to Dermatophagoides pteronyssinus

    Summary
    EudraCT number
    2014-004429-42
    Trial protocol
    ES  
    Global end of trial date
    07 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Jan 2019
    First version publication date
    26 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DIA-Der-02-14
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Diater Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.
    Sponsor organisation address
    Avenida Gregorio Peces Barba, 2, Leganes / Madrid, Spain, 28918
    Public contact
    Medical department, Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, S.A., 0034 914966013, departamento.medico@diater.com
    Scientific contact
    Medical Department, Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, S.A., 0034 914966013, departamento.medico@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
    30 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the maximum non- reactive dose of Polymerized Dermatophagoides pteronyssinus, administered intradermally
    Protection of trial subjects
    subjects should stay under medical surveillance in the center at least 60 minutes after drug administration . Additionally subjects received a telephone call from the investigator team 24 hours later the administration to register and assess any potential late adverse event
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 May 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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    all patients recruited completed the study

    Pre-assignment
    Screening details
    Positive levels of IgE antibodies against Dermatophagoides pteronyssinus in the previous year to inclusión was considered valid. Wash-out period for : Antihistamines: 7 days. Short-acting beta-2 adrenergics: 4 hours. Long-acting beta-2 adrenergics: 12 hours. Antileukotrienes: 24 hours, inhaled corticosteroids: 12 hours, chromones: 24 hours

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Given that all efficacy study endpoints are objectively measured and can not be modified by either subject or investigator , blinding was considered no necessary for this study.

    Arms
    Arm title
    Der p pol
    Arm description
    Polymerized Dermatophagoides pteronisynuss at 4 different doses: 0.001 , 0.01 , 0.1 and 1 mg/ml
    Arm type
    Experimental

    Investigational medicinal product name
    Polymerized Dermatophagoides pteronyssinus
    Investigational medicinal product code
    Der p pol
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    4 different concentrations (0.001, 0.01, 0.1 and 1 mcg/mL ) of the IMP was administered to each single patient . Dose of each concentrarion was 0.1 ml

    Number of subjects in period 1
    Der p pol
    Started
    40
    Completed
    40

    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
    40 40
    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)
    40 40
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    28.38 ± 7.86 -
    Gender categorical
    Units: Subjects
        Female
    23 23
        Male
    17 17
    Study disease
    Units: Subjects
        Rhinits and/or Rhinoconjunctivits with asthma
    32 32
        Rhinitis/Rhinconjunctivitis w/ asthma not reported
    8 8
    Subject analysis sets

    Subject analysis set title
    Per protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The statistical acceptance criteria for eligible subjects are: * A regression line of at least 3 concentrations with a correlation coefficient > 0.85. * A slope of the regression line > 0.1. * Values obtained after regression within the concentration values used.

    Subject analysis set title
    ITT population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    all enrolled subjects receiving at least 3 out of 4 drug concentration tested

    Subject analysis sets values
    Per protocol ITT population
    Number of subjects
    17
    40
    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)
    17
    40
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    29.71 ± 8.53
    28.38 ± 7.86
    Gender categorical
    Units: Subjects
        Female
    10
    23
        Male
    7
    17
    Study disease
    Units: Subjects
        Rhinits and/or Rhinoconjunctivits with asthma
    15
        Rhinitis/Rhinconjunctivitis w/ asthma not reported
    2

    End points

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    End points reporting groups
    Reporting group title
    Der p pol
    Reporting group description
    Polymerized Dermatophagoides pteronisynuss at 4 different doses: 0.001 , 0.01 , 0.1 and 1 mg/ml

    Subject analysis set title
    Per protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The statistical acceptance criteria for eligible subjects are: * A regression line of at least 3 concentrations with a correlation coefficient > 0.85. * A slope of the regression line > 0.1. * Values obtained after regression within the concentration values used.

    Subject analysis set title
    ITT population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    all enrolled subjects receiving at least 3 out of 4 drug concentration tested

    Primary: Maximum non-reactive drug concentration

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    End point title
    Maximum non-reactive drug concentration [1]
    End point description
    Maximum non-reactive drug concentration was defined as those concentration inducing a largest wheal diameter equal to 2.9 mm
    End point type
    Primary
    End point timeframe
    Immediately after administration, and 15 minutes after. Largest wheal diameter was calculated by subtracting the initial wheal induced to the final wheal obtained. In the case of obtaining a wheal with the negative control (manitol) it was also subtracted
    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 analyses as required (p-values for group comparisons) is not applicable to calculate the primary endpoint of this study. Instead, a regression line was calculated using the logarithmic values (logarithm to base 10) of the largest wheal size from the 4 IMP doses tested. The logarithmic concentration value inducing a wheal equal to 2.9 mm was calculated by interpolation. This value was thereafter converted into a non-logarithmic value to obtain the final non-reactive concentration
    End point values
    Per protocol
    Number of subjects analysed
    17
    Units: mcg/mL
        arithmetic mean (standard deviation)
    0.1 ± 0.1
    No statistical analyses for this end point

    Secondary: flare of the wheal

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    End point title
    flare of the wheal
    End point description
    Erythema induced by the non-reactive concentration
    End point type
    Secondary
    End point timeframe
    Time of administration and 15 minutes after. Largest erythema diameter was calculated by subtracting the initial wheal induced to the final value obtained . in the case of obtaining an erythema with the negative control (manitol), it was also substracted
    End point values
    Per protocol
    Number of subjects analysed
    17
    Units: mm
        arithmetic mean (standard deviation)
    30 ± 8.96
    No statistical analyses for this end point

    Secondary: baseline Specific IgE antibodies to native extract

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    End point title
    baseline Specific IgE antibodies to native extract
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    IgE values were calculated at baseline visit
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: kU/L
        arithmetic mean (standard deviation)
    32.64 ± 35.84
    28.41 ± 30.41
    No statistical analyses for this end point

    Secondary: Final Specific IgE antibodies to native extract

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    End point title
    Final Specific IgE antibodies to native extract
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    values measured at 30-day follow-up after single drug administration
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: kU/L
        arithmetic mean (standard deviation)
    31.33 ± 35.70
    28.08 ± 30.97
    No statistical analyses for this end point

    Secondary: Baseline Specific IgG4 antibodies to native extract

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    End point title
    Baseline Specific IgG4 antibodies to native extract
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    baseline visit
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: mgA/L
        arithmetic mean (standard deviation)
    0.64 ± 0.73
    0.57 ± 0.53
    No statistical analyses for this end point

    Secondary: Final Specific IgG4 antibodies to native extract

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    End point title
    Final Specific IgG4 antibodies to native extract
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    Measured at final visit (30-day follow-up)
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: mgA/L
        arithmetic mean (standard deviation)
    0.65 ± 0.85
    0.56 ± 0.59
    No statistical analyses for this end point

    Secondary: Baseline Specific IgE antibodies to Der p 1

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    End point title
    Baseline Specific IgE antibodies to Der p 1
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    Measure at baseline visit
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: kU/L
        arithmetic mean (standard deviation)
    18.1 ± 26.91
    15.17 ± 23.44
    No statistical analyses for this end point

    Secondary: Final Specific IgE antibodies to Der p 1

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    End point title
    Final Specific IgE antibodies to Der p 1
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    Measured at final visit (30-day follow-up)
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: kU/L
        arithmetic mean (standard deviation)
    18.54 ± 28.56
    15.29 ± 24.29
    No statistical analyses for this end point

    Secondary: Baseline Specific IgG4 antibodies to Der p 1

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    End point title
    Baseline Specific IgG4 antibodies to Der p 1
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    baseline visit
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: mgA/L
        arithmetic mean (standard deviation)
    0.17 ± 0.20
    0.14 ± 0.14
    No statistical analyses for this end point

    Secondary: Final Specific IgG4 antibodies to Der p 1

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    End point title
    Final Specific IgG4 antibodies to Der p 1
    End point description
    serologic values
    End point type
    Secondary
    End point timeframe
    final visit (30-day follow-up)
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: mgA/L
        arithmetic mean (standard deviation)
    0.17 ± 0.23
    0.13 ± 0.16
    No statistical analyses for this end point

    Secondary: Baseline Specific IgE antibodies to Der p 2

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    End point title
    Baseline Specific IgE antibodies to Der p 2
    End point description
    End point type
    Secondary
    End point timeframe
    baseline visit before drug administration
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: kU/L
        arithmetic mean (standard deviation)
    21.04 ± 28.24
    19.27 ± 25.00
    No statistical analyses for this end point

    Secondary: Final Specific IgE antibodies to Der p 2

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    End point title
    Final Specific IgE antibodies to Der p 2
    End point description
    End point type
    Secondary
    End point timeframe
    values measured at 30-day follow-up after single drug administration
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: kU/L
        arithmetic mean (standard deviation)
    21.60 ± 29.68
    19.56 ± 25.85
    No statistical analyses for this end point

    Secondary: Baseline Specific IgG4 antibodies to Der p 2

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    End point title
    Baseline Specific IgG4 antibodies to Der p 2
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline visit before drug administration
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: mgA/L
        arithmetic mean (standard deviation)
    0.17 ± 0.23
    0.16 ± 0.20
    No statistical analyses for this end point

    Secondary: Final Specific IgG4 antibodies to Der p 2

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    End point title
    Final Specific IgG4 antibodies to Der p 2
    End point description
    End point type
    Secondary
    End point timeframe
    values measured at 30-day follow-up after single drug administration
    End point values
    Per protocol ITT population
    Number of subjects analysed
    17
    40
    Units: mgA/L
        arithmetic mean (standard deviation)
    0.16 ± 0.20
    0.16 ± 0.19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    1 month after study drug administration
    Adverse event reporting additional description
    The occurrence of adverse events was to be sought by non-directive questionning of the patient at each visit including 1 phone interview 24 hours after treatment administration. Adverse events also could have been detected when they were volunteered by the patient during or between visits or through physical examination or other assessment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    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: this is a short- duration study , with a small number of subjects required and a single intradermal drug dose administration . Neither related (local or systemic reactions) nor unrelated adverse events were reported in this study

    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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