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    Clinical Trial Results:
    A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects.

    Summary
    EudraCT number
    		 2014-000279-15
    Trial protocol
    		 PL  
    Global end of trial date
    23 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Feb 2018
    First version publication date
    28 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CP009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01921257
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Circassia Limited
    Sponsor organisation address
    Robert Robinson Avenue, Oxford, United Kingdom,
    Public contact
    CP009-ClinicalTrialInformation-Desk, Circassia Limited, +44 1865598078, CP009ClinicalTrialInformationDesk@circassia.co.uk
    Scientific contact
    CP009-ClinicalTrialInformation-Desk, Circassia Limited, +44 1865598078, CP009ClinicalTrialInformationDesk@circassia.co.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001054-PIP10-03
    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
    12 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.
    Protection of trial subjects
    Use of MicronJet 600 TM intradermal needle
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jul 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
    Poland: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Minimum of 12 and maximum of 18 to be enrolled with a history of moderate / severe allergic rhinoconjunctivitis with or without controlled asthma on exposure to cats

    Period 1
    Period 1 title
    Placebo run-in
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Carer

    Arms
    Arm title
    		 Placebo run-in
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Cat-PAD placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Two intradermal injections of placebo (0.9% saline) given two weeks apart

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This was a paediatric study therefore both subject and carer (parent / guardian) were blinded. All other roles were unblinded.
    Number of subjects in period 1
    		Placebo run-in
    Started
    16
    Completed
    16
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind [2]
    Roles blinded
    		 Subject, Carer

    Arms
    Arm title
    		 Cat-PAD
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cat-PAD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Eight intradermal injections of 6 nmol Cat-PAD given four weeks apart

    Notes
    [2] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This was a paediatric study therefore both subject and carer (parent / guardian) were blinded. All other roles were unblinded.
    Number of subjects in period 2
    		Cat-PAD
    Started
    16
    Completed
    13
    Not completed
    3
         Non specified
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo run-in
    Reporting group description
    		 -

    Reporting group values
    		 Placebo run-in Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 16 16
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Placebo run-in
    Reporting group description
    		 -
    Reporting group title
    Cat-PAD
    Reporting group description
    		 -

    Primary: Proportion and frequency of AEs Cat-PAD compared to placebo

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    End point title
    		 Proportion and frequency of AEs Cat-PAD compared to placebo [1]
    End point description
    End point type
    Primary
    End point timeframe
    Duration of Study
    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: Descriptive statistics only
    End point values
    		 Placebo run-in Cat-PAD
    Number of subjects analysed
    16
    16
    Units: Adverse Events
    5
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of Study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo run-in
    Reporting group description
    		 -

    Reporting group title
    Cat-PAD
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo run-in Cat-PAD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo run-in Cat-PAD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 16 (31.25%)
    12 / 16 (75.00%)
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    7
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    5 / 16 (31.25%)
         occurrences all number
    1
    8
    Bronchitis
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Laryngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Tonsillitis
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1

    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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