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    Clinical Trial Results:
    A double blind placebo controlled randomised trial to study the effects of birch pollen specific immunotherapy (BP-SIT) on the symptoms of the oral allergy syndrome in adult patients.

    Summary
    EudraCT number
    2011-004078-26
    Trial protocol
    GB  
    Global end of trial date
    03 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2020
    First version publication date
    05 Jan 2020
    Other versions
    Summary report(s)
    OAS Findings Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    10/143/FRE
    Additional study identifiers
    ISRCTN number
    ISRCTN01027357
    US NCT number
    NCT01431859
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Brighton and Sussex University Hospitals Trust
    Sponsor organisation address
    Royal Sussex County Hospital Eastern Road, Brighton, United Kingdom, BN2 5BE
    Public contact
    Mr Scott Harfield, Brighton and Sussex University Hospitals Trust, 044 01273 696955, Scott.Harfield@bsuh.nhs.uk
    Scientific contact
    Mr Scott Harfield, Brighton and Sussex University Hospitals Trust, 044 01273 696955, Scott.Harfield@bsuh.nhs.uk
    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 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Does immunotherapy (the process of giving small but increasing doses of birch pollen as injections under the skin) improve symptoms of mouth and throat itch, irritation and swelling on eating apples in patients with oral allergy syndrome?
    Protection of trial subjects
    Patients were given full advice and information through the participation information sheet before being asked if they wished to participate in the study and once involved they were asked at each visit whether they wished to continue and were free to withdraw from the study. After treatment the patients were monitored to ensure they were in no distress and all was well before being told that they were free to return home. They were given the contact numbers of the research staff in case they had any queries and also the contact details of the Patient Advice and Liaison Service
    Background therapy
    None
    Evidence for comparator
    This was a placebo controlled trial. A placebo solution was supplied as a comparator. The placebo preparation used is the verum solution without any added allergen substance, also termed Allergovit diluent.
    Actual start date of recruitment
    06 Aug 2012
    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
    United Kingdom: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 32 patients were randomised and contributed data. They were recruited at two sites in the UK:Royal Sussex County Hospital, Brighton and Homerton Hospital London between 2012 and 2017

    Pre-assignment
    Screening details
    143 patients were screened in Brighton and 16 at Homerton. The lower number at Homerton being due to them having a database which allowed them to pre-identify potential patients.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject
    Blinding implementation details
    The active food challenges provided to the patients consisted of a base containing yogurt, orange juice, apple juice, processed apple sauce and oatflakes, to which aliquots of freshly shredded apple are added. Each meal was prepared by an investigator 5 minutes before administration and handed to the supervising clinician who remains unaware of the content. Placebo meals are identical but contain no fresh apple. The vaccines and placebo were prepared by the same manufacturer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treatment
    Arm description
    The treatment arm recieved a modified birch allergen vaccine (Allergovit) in which the allergenic proteins have been treated with aldehydes to reduce their potential for side-effects, while retaining their ability to be recognised by T-cells (the principal immunological target for SIT). This type of vaccine is in widespread use in Europe.
    Arm type
    Active comparator

    Investigational medicinal product name
    Allergovit
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    This consisted of a 7 week course of subctaneous injections. Strength = 1,000 TU/ml ,Dosage in ml 0.1, 0.2, 0.4, 0.8. Strength = 10, 000 TU/ml Dosage in ml 0.15, 0.3, 0.6

    Arm title
    Placebo
    Arm description
    The placebo preparation used was the verum solution without any added allergen substance, also termed Allergovit diluent.
    Arm type
    Placebo

    Investigational medicinal product name
    Allergovit
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    This consisted of a 7 week course of subctaneous injections. Strength = 1,000 TU/ml ,Dosage in ml 0.1, 0.2, 0.4, 0.8. Strength = 10, 000 TU/ml Dosage in ml 0.15, 0.3, 0.6

    Number of subjects in period 1
    Treatment Placebo
    Started
    17
    15
    Completed
    12
    11
    Not completed
    5
    4
         Lost to follow-up
    5
    4

    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
    32 32
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Mean age
    Units: years
        arithmetic mean (standard deviation)
    39.4 ( 11.4 ) -
    Gender categorical
    Units: Subjects
        Female
    25 25
        Male
    7 7

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    The treatment arm recieved a modified birch allergen vaccine (Allergovit) in which the allergenic proteins have been treated with aldehydes to reduce their potential for side-effects, while retaining their ability to be recognised by T-cells (the principal immunological target for SIT). This type of vaccine is in widespread use in Europe.

    Reporting group title
    Placebo
    Reporting group description
    The placebo preparation used was the verum solution without any added allergen substance, also termed Allergovit diluent.

    Primary: Double Blind Placebo Controlled Food Challenge

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    End point title
    Double Blind Placebo Controlled Food Challenge [1]
    End point description
    The change in level was calculated for year 1 and year 2 as Year 1 or 2 - Year 0. A negative change indicates a higher threshold at Year 0 and therefore a worse outcome at year1/2. A positive change indicates a higher threshold at Year 1 or 2 and therefore a positive outcome.
    End point type
    Primary
    End point timeframe
    Year 1 and year 2
    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: See attached documents for results
    End point values
    Treatment Placebo
    Number of subjects analysed
    4
    7
    Units: Concentration of apple
    25
    41
    Attachments
    Untitled (Filename: OAS analysis 1.0 signed.pdf)
    No statistical analyses for this end point

    Secondary: Skin test sensitivity

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    End point title
    Skin test sensitivity
    End point description
    End point type
    Secondary
    End point timeframe
    Two years
    End point values
    Treatment Placebo
    Number of subjects analysed
    13
    14
    Units: Diameter of reaction in mm
        arithmetic mean (standard deviation)
    0.31 ( 3.31 )
    0.14 ( 2.58 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For the duration of the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18
    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: See attached document for list of AEs there were no SAEs

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2011
    1. The protocol has been amended to more accurately reflect the contra-indications contained within the SmPC. 2. Further information about the manufacture and control of placebo is included 3. A copy of the manufacturer’s authorisation for the placebo is included. 4. The “Allergovit diluent” is now specified as being the same as the placebo product in the protocol.
    08 Oct 2012
    1. GP Practices to search their databases for hay fever sufferers and invite them to take part in the study by sending them the GP Invitation Letter (Version 1.2, dated 13/08/2012). 2. The protocol was amended so that people with autoimmune diseases who are not on immunosuppressive drugs (e.g. Coeliac disease) could be included. 3. Diary card approved.
    09 Oct 2012
    The addition of PIC sites.
    24 Jan 2013
    Addition of an open apple challenge at the end of the double blind placebo controlled food challenges.
    06 Jun 2013
    Homerton Hospital becoming an additional site for the study.
    10 Jun 2013
    Amendment to the protocol, patient information sheet and advert to be more generic, and less BSUH specific in order for the study to become multi-centred. Also the addition of an invitation letter to those patients who are interested in research.
    23 Sep 2013
    The protocol was updated to allow appropriately qualified and trained nurses to give the IMP injection, as well as a doctor.
    28 Oct 2013
    To amend the recruitment procedure so that delegated nurses can consent patients (but eligibility will still be confirmed by a doctor). No documentation is affected in this amendment.

    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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