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    Clinical Trial Results:
    A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

    Summary
    EudraCT number
    		 2014-001662-94
    Trial protocol
    		 IT   DE   NL   LT   LV  
    Global end of trial date
    13 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2018
    First version publication date
    03 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TH005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02150343
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Circassia Limited
    Sponsor organisation address
    Rober Robinson Avenue, Oxford, United Kingdom,
    Public contact
    TH005-ClinicalTrialInformation-Desk, Circassia Ltd., +44 01865 598078 , TH005ClinicalTrialInformationDesk@circassia.co.uk
    Scientific contact
    TH005-ClinicalTrialInformation-Desk, Circassia Ltd., +44 01865 598078 , TH005ClinicalTrialInformationDesk@circassia.co.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
    28 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of HDM-SPIRE in the reduction of symptoms and the use of allergy rescue medication associated with HDM allergy in subjects with clinically relevant symptoms.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Spain: 49
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 64
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Latvia: 22
    Country: Number of subjects enrolled
    Lithuania: 45
    Country: Number of subjects enrolled
    United States: 372
    Country: Number of subjects enrolled
    Canada: 96
    Country: Number of subjects enrolled
    South Africa: 49
    Worldwide total number of subjects
    715
    EEA total number of subjects
    198
    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)
    713
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 3625 subjects were screened of which 2910 (80.3%) were not randomised. Most common reasons for screen failure were related to Der p/Der f specific IgE, TRSS, evidence of partly or uncontrolled asthma and history of another disease or disorder.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Arm title
    		 All Randomised
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    HDM-SPIRE 12 nmol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    12 nmol nanomole(s) per day intradermal injection given at 4 weekly intervals (4 administrations)

    Investigational medicinal product name
    HDM-SPIRE 20 nmol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    20 nmol nanomole(s) per day intradermal injection given at 4 weekly intervals (4 administrations)

    Investigational medicinal product name
    HDM-SPIRE 12 nmol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    12 nmol nanomole(s) per day intradermal injection given at 4 weekly intervals (8 administrations)

    Investigational medicinal product name
    HDM-SPIRE Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    8 intradermal administrations at 4 weekly intervals

    Number of subjects in period 1
    		All Randomised
    Started
    715
    Completed
    715
    Period 2
    Period 2 title
    Treatment and Assessment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 4 x 12 nmol HDM-SPIRE
    Arm description
    		 4 x 12 nmol HDM-SPIRE followed by 4 x placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    HDM-SPIRE 12 nmol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    12 nmol nanomole(s) per day intradermal injection given at 4 weekly intervals (4 administrations)

    Investigational medicinal product name
    HDM-SPIRE Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    4 intradermal administrations at 4 weekly intervals

    Arm title
    		 4 x 20 nmol HDM-SPIRE
    Arm description
    		 4 x 20 nmol HDM-SPIRE followed by 4 x placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    HDM-SPIRE 20 nmol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    20 nmol nanomole(s) per day intradermal injection given at 4 weekly intervals (4 administrations)

    Investigational medicinal product name
    HDM-SPIRE Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    4 intradermal administrations at 4 weekly intervals

    Arm title
    		 8 x 12 nmol HDM-SPIRE
    Arm description
    		 8 x 12 nmol HDM-SPIRE
    Arm type
    		 Experimental

    Investigational medicinal product name
    HDM-SPIRE 12 nmol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    12 nmol nanomole(s) per day intradermal injection given at 4 weekly intervals (8 administrations)

    Arm title
    		 Placebo
    Arm description
    		 8 x placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    HDM-SPIRE Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    8 intradermal administrations at 4 weekly intervals

    Number of subjects in period 2
    		4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Started
    180
    178
    179
    178
    Completed
    159
    158
    166
    168
    Not completed
    21
    20
    13
    10
         Consent withdrawn by subject
    13
    10
    9
    4
         Non-specified
    2
    6
    1
    2
         Adverse event, non-fatal
    2
    -
    1
    1
         Lost to follow-up
    4
    4
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 715 715
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 713 713
        From 65-84 years
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 454 454
        Male
    		 261 261

    End points

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    End points reporting groups
    Reporting group title
    All Randomised
    Reporting group description
    		 -
    Reporting group title
    4 x 12 nmol HDM-SPIRE
    Reporting group description
    		 4 x 12 nmol HDM-SPIRE followed by 4 x placebo

    Reporting group title
    4 x 20 nmol HDM-SPIRE
    Reporting group description
    		 4 x 20 nmol HDM-SPIRE followed by 4 x placebo

    Reporting group title
    8 x 12 nmol HDM-SPIRE
    Reporting group description
    		 8 x 12 nmol HDM-SPIRE

    Reporting group title
    Placebo
    Reporting group description
    		 8 x placebo

    Primary: Mean Combined Score (CS) during the PAC3 period in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group.

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    End point title
    		 Mean Combined Score (CS) during the PAC3 period in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. [1]
    End point description
    End point type
    Primary
    End point timeframe
    Weeks 50 to 52 after randomisation
    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: The primary reporting value was least squares mean.
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    159
    165
    168
    Units: Combined Score
        least squares mean (standard error)
    1.69 ( 0.089 )
    1.51 ( 0.089 )
    1.40 ( 0.086 )
    1.56 ( 0.087 )
    No statistical analyses for this end point

    Secondary: Clinical Global Impression of Change in Rhinoconjunctivitis Symptoms for the HDM-SPIRE treatment groups compared with placebo at the end of study.

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    End point title
    		 Clinical Global Impression of Change in Rhinoconjunctivitis Symptoms for the HDM-SPIRE treatment groups compared with placebo at the end of study.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    159
    156
    158
    160
    Units: p-value
        Moderately or very much better
    55
    70
    61
    64
        Any improvement
    101
    109
    103
    109
        No change
    45
    41
    48
    43
        Any worsening
    13
    6
    7
    8
    No statistical analyses for this end point

    Secondary: Mean TRSS in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period

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    End point title
    		 Mean TRSS in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    159
    165
    168
    Units: TRSS
        least squares mean (standard error)
    8.96 ( 0.468 )
    8.03 ( 0.467 )
    7.97 ( 0.451 )
    8.16 ( 0.455 )
    No statistical analyses for this end point

    Secondary: Mean component scores of the TRSS (nasal) in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period.

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    End point title
    		 Mean component scores of the TRSS (nasal) in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    159
    165
    168
    Units: TNSS
        least squares mean (standard error)
    4.99 ( 0.244 )
    4.40 ( 0.243 )
    4.45 ( 0.235 )
    4.44 ( 0.237 )
    No statistical analyses for this end point

    Secondary: Mean component scores of the TRSS (non-nasal) in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period.

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    End point title
    		 Mean component scores of the TRSS (non-nasal) in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    159
    165
    168
    Units: TNNSS
        least squares mean (standard error)
    3.99 ( 0.242 )
    3.64 ( 0.242 )
    3.53 ( 0.233 )
    3.73 ( 0.235 )
    No statistical analyses for this end point

    Secondary: Mean RMS in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period

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    End point title
    		 Mean RMS in the HDM-SPIRE treatment groups compared with placebo during the PAC3 period
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    159
    165
    168
    Units: RMS
        least squares mean (standard error)
    0.57 ( 0.048 )
    0.51 ( 0.048 )
    0.41 ( 0.047 )
    0.55 ( 0.047 )
    No statistical analyses for this end point

    Secondary: Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score in the HDM-SPIRE treatment groups compared with placebo at the end of the PAC3 period

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    End point title
    		 Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score in the HDM-SPIRE treatment groups compared with placebo at the end of the PAC3 period
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    158
    166
    167
    Units: RQLQ Score
        least squares mean (standard error)
    2.02 ( 0.098 )
    1.76 ( 0.098 )
    1.72 ( 0.095 )
    1.89 ( 0.095 )
    No statistical analyses for this end point

    Secondary: Number of days subjects in the HDM-SPIRE treatment groups have no moderate or severe RSS symptoms without rescue medication usage compared with placebo during the PAC3 period.

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    End point title
    		 Number of days subjects in the HDM-SPIRE treatment groups have no moderate or severe RSS symptoms without rescue medication usage compared with placebo during the PAC3 period.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 50 to 52 after randomisation
    End point values
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE Placebo
    Number of subjects analysed
    160
    159
    165
    168
    Units: Number of Days
        least squares mean (standard error)
    25.9 ( 2.90 )
    33.5 ( 2.89 )
    33.9 ( 2.80 )
    31.1 ( 2.812 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Randomisation to end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    4 x 12 nmol HDM-SPIRE
    Reporting group description
    		 -

    Reporting group title
    4 x 20 nmol HDM-SPIRE
    Reporting group description
    		 -

    Reporting group title
    8 x 12 nmol HDM-SPIRE
    Reporting group description
    		 -

    Reporting group title
    HDM-SPIRE Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE HDM-SPIRE Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 180 (3.33%)
    4 / 178 (2.25%)
    4 / 178 (2.25%)
    3 / 178 (1.69%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Urinary retention postoperative
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin reaction
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 178 (0.00%)
    1 / 178 (0.56%)
    0 / 178 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 4 x 12 nmol HDM-SPIRE 4 x 20 nmol HDM-SPIRE 8 x 12 nmol HDM-SPIRE HDM-SPIRE Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    137 / 180 (76.11%)
    132 / 178 (74.16%)
    132 / 178 (74.16%)
    129 / 178 (72.47%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 180 (5.56%)
    11 / 178 (6.18%)
    13 / 178 (7.30%)
    12 / 178 (6.74%)
         occurrences all number
    26
    30
    28
    16
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 180 (6.11%)
    4 / 178 (2.25%)
    8 / 178 (4.49%)
    9 / 178 (5.06%)
         occurrences all number
    11
    4
    9
    11
    Oropharyngeal pain
         subjects affected / exposed
    6 / 180 (3.33%)
    2 / 178 (1.12%)
    14 / 178 (7.87%)
    6 / 178 (3.37%)
         occurrences all number
    7
    2
    14
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    37 / 180 (20.56%)
    32 / 178 (17.98%)
    38 / 178 (21.35%)
    41 / 178 (23.03%)
         occurrences all number
    59
    54
    54
    58
    Upper respiratory tract infection
         subjects affected / exposed
    22 / 180 (12.22%)
    24 / 178 (13.48%)
    21 / 178 (11.80%)
    20 / 178 (11.24%)
         occurrences all number
    27
    32
    32
    26
    Sinusitis
         subjects affected / exposed
    13 / 180 (7.22%)
    14 / 178 (7.87%)
    15 / 178 (8.43%)
    12 / 178 (6.74%)
         occurrences all number
    16
    15
    15
    16
    Influenza
         subjects affected / exposed
    7 / 180 (3.89%)
    12 / 178 (6.74%)
    15 / 178 (8.43%)
    11 / 178 (6.18%)
         occurrences all number
    7
    15
    15
    12
    Urinary tract infection
         subjects affected / exposed
    5 / 180 (2.78%)
    7 / 178 (3.93%)
    10 / 178 (5.62%)
    6 / 178 (3.37%)
         occurrences all number
    6
    7
    14
    9
    Bronchitis
         subjects affected / exposed
    9 / 180 (5.00%)
    4 / 178 (2.25%)
    6 / 178 (3.37%)
    7 / 178 (3.93%)
         occurrences all number
    9
    4
    8
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2015
    Protocol version 3.0 from 2.1. Changes to statistical analysis.
    02 Jun 2016
    Protocol version 4.0 from 3.0. Changes to eligibility criteria. Clarification on rescreening. Increase of age limit to 70.

    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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