Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase II-III trial assessing the efficacy and safety of three doses of the ALK HDM tablet in house dust mite allergic subjects

    Summary
    EudraCT number
    		 2006-001795-20
    Trial protocol
    		 SE   DE   ES   DK   GB   IT  
    Global end of trial date
    23 Apr 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    26 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MT-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló A/S
    Sponsor organisation address
    Bøge Allé 1, Hørsholm, Denmark, 2970
    Public contact
    Clinical Development, ALK-Abelló A/S, +45 45747576, ClinicalTrials@alk.net
    Scientific contact
    Clinical Development, ALK-Abelló A/S, +45 45747576, ClinicalTrials@alk.net
    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
    23 Apr 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of specific immunotherapy with three dosages of the ALK HDM tablet given once daily compared to placebo in subjects suffering from house dust mite allergy. The evaluation is based on reduction in inhaled corticosteroid (ICS)
    Protection of trial subjects
    Safety surveillance Subjects had access to symptomatic medications if needed. As regards ICS and medications to relieve asthma and rhinoconjunctivitis symptoms these medications were provided by the sponsor
    Background therapy
    		 Subjects were provided with the asthma rescue medication: • Budesonide Turbuhalers®, 100 μg or 200 μg. • Salbutamol inhaler, 200 μg per inhalation. Dosing: Prn. Subjects were supplied with the following rescue medication: • Desloratadine 5 mg tablets. Dosing: 1 tablet daily prn. • Budesonide nasal spray 32 μg micronised budesonide per actuation. Dosing: the lowest dosage acceptable to the subject. In case of asthma exacerbations or severe rhinoconjunctivitis symptoms which could not be relieved with the asthma medication or rhinoconjunctivitis rescue medication provided, the investigator could treat the subject with an oral corticosteroid. The oral steroid provided was: • Prednisone/prednisolone 5 mg tablets. Dosing: Up to 50 mg daily for three day
    Evidence for comparator
    		 Placebo comparator
    Actual start date of recruitment
    18 Aug 2006
    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: 19
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    Denmark: 67
    Country: Number of subjects enrolled
    France: 64
    Country: Number of subjects enrolled
    Germany: 128
    Country: Number of subjects enrolled
    Italy: 43
    Country: Number of subjects enrolled
    Poland: 246
    Worldwide total number of subjects
    604
    EEA total number of subjects
    604
    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)
    39
    Adults (18-64 years)
    559
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects was recruited from 81 sites in Denmark, France, Germany, Italy, Poland, Spain, Sweden and U.K. The trial was initiated in the summer of 2006 (first subject first visit − 18 August 2006)

    Pre-assignment
    Screening details
    		 Male or female ≥14 years, clinical history ≥1 year of HDM-induced mild to moderate persistent asthma (steps 2 and 3 according the GINA guidelines) and mild to severe allergic rhinitis (ARIA guidelines), positive SPT (≥3 mm) and specific IgE (≥ class 2) to D. pteronyssinus and/or D. farinae, FEV1 > 70% of predicted value with appropriate medication.

    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
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    The daily dose of IMP was one lyophilisate [tablet], preferably taken in the morning. The tablet was placed under the tongue, and swallowing was to be avoided for one minute. In addition, eating and drinking was not allowed within 5 minutes after intake of IMP.

    Arm title
    		 1 SQ-HDM
    Arm description
    		 Active IMP, strength 1 SQ-HDM
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    The daily dose of IMP was one lyophilisate [tablet], preferably taken in the morning. The tablet was placed under the tongue, and swallowing was to be avoided for one minute. In addition, eating and drinking was not allowed within 5 minutes after intake of IMP.

    Arm title
    		 3 SQ-HDM
    Arm description
    		 Active IMP, strength 3 SQ-HDM
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    The daily dose of IMP was one lyophilisate [tablet], preferably taken in the morning. The tablet was placed under the tongue, and swallowing was to be avoided for one minute. In addition, eating and drinking was not allowed within 5 minutes after intake of IMP.

    Arm title
    		 6 SQ-HDM
    Arm description
    		 Active IMP, strength 6 SQ-HDM
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    The daily dose of IMP was one lyophilisate [tablet], preferably taken in the morning. The tablet was placed under the tongue, and swallowing was to be avoided for one minute. In addition, eating and drinking was not allowed within 5 minutes after intake of IMP.

    Number of subjects in period 1
    		Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM
    Started
    143
    146
    159
    156
    Completed
    126
    132
    134
    140
    Not completed
    17
    14
    25
    16
         Consent withdrawn by subject
    3
    3
    6
    3
         Adverse event, non-fatal
    1
    2
    8
    4
         Not specified
    3
    3
    2
    1
         Pregnancy
    2
    1
    2
    -
         Non-compliance
    3
    3
    3
    5
         Lost to follow-up
    5
    2
    4
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    1 SQ-HDM
    Reporting group description
    		 Active IMP, strength 1 SQ-HDM

    Reporting group title
    3 SQ-HDM
    Reporting group description
    		 Active IMP, strength 3 SQ-HDM

    Reporting group title
    6 SQ-HDM
    Reporting group description
    		 Active IMP, strength 6 SQ-HDM

    Reporting group values
    		 Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM Total
    Number of subjects
    		 143 146 159 156 604
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 11 7 12 9 39
        Adults (18-64 years)
    		 131 139 145 144 559
        From 65-84 years
    		 1 0 2 3 6
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.4 ± 12.1 31.7 ± 12 31.6 ± 12.4 31.6 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    		 67 71 75 73 286
        Male
    		 76 75 84 83 318

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    1 SQ-HDM
    Reporting group description
    		 Active IMP, strength 1 SQ-HDM

    Reporting group title
    3 SQ-HDM
    Reporting group description
    		 Active IMP, strength 3 SQ-HDM

    Reporting group title
    6 SQ-HDM
    Reporting group description
    		 Active IMP, strength 6 SQ-HDM

    Primary: reduction of ICS dose from baseline to end of trial after approximately 1 year of treatment

    		 Close Top of page
    End point title
    		 reduction of ICS dose from baseline to end of trial after approximately 1 year of treatment
    End point description
    The primary efficacy analysis defined in the protocol was the comparison of each of the 3 active dose groups to placebo. The approach to this multiple comparisons issue was defined in the protocol as a hierarchical ordering of the null hypotheses, with the following ranking: 1. SQ HDM SLIT-tablet 6 DU versus placebo 2. SQ HDM SLIT-tablet 3 DU versus placebo 3. SQ HDM SLIT-tablet 1 DU versus placebo
    End point type
    Primary
    End point timeframe
    approximately 1 year
    End point values
    		 Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM
    Number of subjects analysed
    143
    146
    159
    156
    Units: microgram(s)/24 hours
        arithmetic mean (standard deviation)
    -122 ± 279
    -155 ± 259
    -116 ± 235
    -204 ± 274
    Statistical analysis title
    		 Reduction in ICS, 6 SQ-HDM versus placebo
    Statistical analysis description
    Comparison of the reduction in ICS from baseline with the reduction observed in the placebo group for 6 SQ-HDM, 3 SQ-HDM and 1 SQ-HDM; in that order
    Comparison groups
    Placebo v 6 SQ-HDM
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0036 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -81.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -136.1
         upper limit
    		 -26.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    27.9
    Notes
    [1] - Statistically significant difference between the 6 DU group and placebo
    Statistical analysis title
    		 Reduction in ICS, 3 SQ-HDM versus placebo
    Comparison groups
    Placebo v 3 SQ-HDM
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8544 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59.8
         upper limit
    		 49.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    27.8
    Notes
    [2] - No statistically significant differences to placebo were observed for the 3 SQ-HDM group
    Statistical analysis title
    		 Reduction in ICS, 1 SQ-HDM versus placebo
    Comparison groups
    Placebo v 1 SQ-HDM
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1334 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -42.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -98.4
         upper limit
    		 13.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    28.4
    Notes
    [3] - No statistically significant difference to placebo were observed for the 1 SQ-HDM group

    Secondary: IgE-blocking factor at end-of-trial visit versus placebo

    		 Close Top of page
    End point title
    		 IgE-blocking factor at end-of-trial visit versus placebo
    End point description
    IgE blocking factor specific for Dermatophagoides pteronyssinus. Samples only collected and analysed from trial sites in Germany and Denmark (30% of the trial population)
    End point type
    Secondary
    End point timeframe
    Approximately 1 year (change from baseline to end of trial in active versus placebo)
    End point values
    		 Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM
    Number of subjects analysed
    36 [4]
    34 [5]
    39 [6]
    44 [7]
    Units: arbitrary units
        arithmetic mean (standard error)
    0 ± 0.08
    0.08 ± 0.12
    0.09 ± 0.16
    0.17 ± 0.17
    Notes
    [4] - Only analysed for sites in Germany and Denmark
    [5] - Only analysed for sites in Germany and Denmark
    [6] - Only analysed for sites in Germany and Denmark
    [7] - Only analysed for sites in Germany and Denmark
    Statistical analysis title
    		 6 SQ-HDM versus placebo
    Statistical analysis description
    A mixed model including as fixed effect the visit 4 value, treatment group, visit and treatment group by visit interaction. For each pairwise comparison all available data from all four treatment groups were included. To allow correlation of observations on the same subject a random subject effect was included in the model. Possible different error variance for each treatment group was adjusted for. The error variance was fitted as seperate compound symmetry for each treatment group
    Comparison groups
    6 SQ-HDM v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.166
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.116
         upper limit
    		 0.215
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Notes
    [8] - Highly statistical significant difference between 6 SQ-HDM and placebo
    Statistical analysis title
    		 3 SQ-HDM versus placebo
    Statistical analysis description
    A mixed model including as fixed effect the visit 4 value, treatment group, visit and treatment group by visit interaction. For each pairwise comparison all available data from all four treatment groups were included. To allow correlation of observations on the same subject a random subject effect was included in the model. Possible different error variance for each treatment group was adjusted for. The error variance was fitted as seperate compound symmetry for each treatment group
    Comparison groups
    Placebo v 3 SQ-HDM
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.096
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.054
         upper limit
    		 0.138
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.021
    Notes
    [9] - Highly statistical significant difference between 3 SQ-HDM and placebo
    Statistical analysis title
    		 1 SQ-HDM versus placebo
    Statistical analysis description
    A mixed model including as fixed effect the visit 4 value, treatment group, visit and treatment group by visit interaction. For each pairwise comparison all available data from all four treatment groups were included. To allow correlation of observations on the same subject a random subject effect was included in the model. Possible different error variance for each treatment group was adjusted for. The error variance was fitted as seperate compound symmetry for each treatment group
    Comparison groups
    Placebo v 1 SQ-HDM
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [10]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.075
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.035
         upper limit
    		 0.115
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Notes
    [10] - Highly statistical significant difference between 1 SQ-HDM and placebo

    Secondary: Change from baseline in FEV1

    		 Close Top of page
    End point title
    		 Change from baseline in FEV1
    End point description
    FEV1 (lung function) was assessed to document the controlled status with respect to asthma of the subjects throughout the trial, in anticipation that all treatment groups would be comparable
    End point type
    Secondary
    End point timeframe
    approximately 1 year (from baseline to end of trial)
    End point values
    		 Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM
    Number of subjects analysed
    133 [11]
    138 [12]
    143 [13]
    147 [14]
    Units: precentage of predicted FEV1
        arithmetic mean (standard deviation)
    -1.3 ± 8.8
    -0.56 ± 10.2
    -2.09 ± 9.4
    -1.81 ± 8.2
    Notes
    [11] - Number of subjects with end-of-trial visit
    [12] - Number of subjects with end-of-trial visit
    [13] - Number of subjects with end-of-trial visit
    [14] - Number of subjects with end-of-trial visit
    Statistical analysis title
    		 6 SQ-HDM vs placebo: change from baseline in %FEV1
    Statistical analysis description
    The estimates are based on a repeated measurements analysis with a linear mixed model. Treatment group, baseline value, visit and treatment group by visit interaction are iuncluded as fixed effects and centre is included as a random effect.
    Comparison groups
    Placebo v 6 SQ-HDM
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.667 [15]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.425
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.362
         upper limit
    		 1.512
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.988
    Notes
    [15] - lung function parameters reflect the controlled status with respect to asthma of the subjects throughout the trial, and all treatment groups were completely comparable
    Statistical analysis title
    		 3 SQ-HDM vs placebo: change from baseline in %FEV1
    Statistical analysis description
    The estimates are based on a repeated measurements analysis with a linear mixed model. Treatment group, baseline value, visit and treatment group by visit interaction are iuncluded as fixed effects and centre is included as a random effect.
    Comparison groups
    Placebo v 3 SQ-HDM
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3802 [16]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.873
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.823
         upper limit
    		 1.077
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.995
    Notes
    [16] - lung function parameters reflect the controlled status with respect to asthma of the subjects throughout the trial, and all treatment groups were completely comparable
    Statistical analysis title
    		 1 SQ-HDM vs placebo: change from baseline in %FEV1
    Statistical analysis description
    The estimates are based on a repeated measurements analysis with a linear mixed model. Treatment group, baseline value, visit and treatment group by visit interaction are iuncluded as fixed effects and centre is included as a random effect.
    Comparison groups
    Placebo v 1 SQ-HDM
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7433 [17]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.329
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.639
         upper limit
    		 2.296
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.003
    Notes
    [17] - lung function parameters reflect the controlled status with respect to asthma of the subjects throughout the trial, and all treatment groups were completely comparable

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    During the entire trial - approximately 2 months prior to randomisation (screening/baseline phase)and 12 months after randomisation (treatment phase)
    Adverse event reporting additional description
    All events meeting the definition of an AE were collected and reported from the first trial-related activity after the subject signed the informed consent and until the end of trial telephone follow-up. Adverse events were defined according to ICH Harmonised Tripartite Guideline E2A, Step 5
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    1 SQ-HDM
    Reporting group description
    		 Active IMP, strength 1 SQ-HDM

    Reporting group title
    3 SQ-HDM
    Reporting group description
    		 Active IMP, strength 3 SQ-HDM

    Reporting group title
    6 SQ-HDM
    Reporting group description
    		 Active IMP, strength 6 SQ-HDM

    Serious adverse events
    		 Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 143 (2.80%)
    6 / 146 (4.11%)
    3 / 159 (1.89%)
    6 / 156 (3.85%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    0 / 156 (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
    Injury, poisoning and procedural complications
    Spinal fracture
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    1 / 159 (0.63%)
    0 / 156 (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
    Surgical and medical procedures
    Adenoidectomy
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (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
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    1 / 159 (0.63%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         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
    Migraine
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         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
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (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
    Abdominal pain
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         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
    Inguinal hernia
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    0 / 156 (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
    Reproductive system and breast disorders
    Testicular torsion
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (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
    Cholelithiasis
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 146 (0.00%)
    1 / 159 (0.63%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         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
    Musculoskeletal and connective tissue disorders
    Bone disorder
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         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
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (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 / 143 (0.00%)
    1 / 146 (0.68%)
    0 / 159 (0.00%)
    0 / 156 (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
    Chronic tonsillitis
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         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
    Gastroenteritis
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 146 (0.00%)
    1 / 159 (0.63%)
    0 / 156 (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
    Tonsillitis
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 146 (0.00%)
    0 / 159 (0.00%)
    0 / 156 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 143 (53.15%)
    80 / 146 (54.79%)
    105 / 159 (66.04%)
    102 / 156 (65.38%)
    Gastrointestinal disorders
    Oral pruritus
         subjects affected / exposed
    5 / 143 (3.50%)
    16 / 146 (10.96%)
    31 / 159 (19.50%)
    27 / 156 (17.31%)
         occurrences all number
    5
    17
    46
    31
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    8 / 143 (5.59%)
    10 / 146 (6.85%)
    14 / 159 (8.81%)
    14 / 156 (8.97%)
         occurrences all number
    8
    11
    17
    21
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    22 / 143 (15.38%)
    21 / 146 (14.38%)
    22 / 159 (13.84%)
    25 / 156 (16.03%)
         occurrences all number
    26
    26
    32
    32
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 143 (7.69%)
    10 / 146 (6.85%)
    9 / 159 (5.66%)
    10 / 156 (6.41%)
         occurrences all number
    13
    13
    10
    10
    Pharyngitis
         subjects affected / exposed
    3 / 143 (2.10%)
    10 / 146 (6.85%)
    8 / 159 (5.03%)
    3 / 156 (1.92%)
         occurrences all number
    3
    12
    9
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Sep 2006
    Modification of in- and exclusion criteria
    14 Dec 2006
    Change on inclusion criterion regarding ACQ score
    05 Nov 2007
    change of trial period from '1-2 years' to '1 year'

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24797423
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 18 02:41:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA