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    Clinical Trial Results:
    PHASE IIB STUDY ON THE SAFETY AND EFFICACY OF BM32, A RECOMBINANT HYPOALLERGENIC VACCINE FOR IMMUNOTHERAPY OF GRASS POLLEN ALLERGY

    Summary
    EudraCT number
    		 2012-000442-35
    Trial protocol
    		 DE   SI   AT   BE   DK   NL  
    Global end of trial date
    14 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Nov 2018
    First version publication date
    17 Nov 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CS-BM32-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01538979
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biomay AG
    Sponsor organisation address
    Lazarettgasse 19, Vienna, Austria, 1090
    Public contact
    Head of Product Development, Biomay AG, 0043 17966296101, a.neubauer@biomay.com
    Scientific contact
    Head of Product Development, Biomay AG, 0043 17966296101, a.neubauer@biomay.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
    02 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of 2 different dose levels of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded during the peak of the grass pollen season of each treatment year.
    Protection of trial subjects
    This trial was conducted in accordance to the principles of GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs, safety labs, vital signs and physical examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2012
    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: 2
    Country: Number of subjects enrolled
    Slovenia: 24
    Country: Number of subjects enrolled
    Austria: 52
    Country: Number of subjects enrolled
    Belgium: 28
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    Germany: 47
    Worldwide total number of subjects
    166
    EEA total number of subjects
    166
    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)
    166
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was performed over three years including a “baseline year” for screening. The severity of grass pollen allergy was assessed before and approx.two weeks after the end of the grass pollen season and via and electronic diary during the grass pollen season. At the end of the baseline year, subjects were randomized to one of the 3 study arms

    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, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BM32 low
    Arm description
    		 BM32 0,2mg/mL
    Arm type
    		 Experimental

    Investigational medicinal product name
    BM32 0,2 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Three pre-seasonal injections at monthly intervals in year 1. One boost after the grass pollen season of year 1. Three pre-seasonal injections at monthly intervals in year 2.

    Arm title
    		 BM32 high
    Arm description
    		 BM32 0,4 mg/mL
    Arm type
    		 Experimental

    Investigational medicinal product name
    BM32 0,4 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Three pre-seasonal injections at monthly intervals in year 1. One boost after the grass pollen season of year 1.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Three pre-seasonal injections at monthly intervals in year 1. One boost after the grass pollen season of year 1. Three pre-seasonal injections at monthly intervals in year 2.

    Number of subjects in period 1
    		BM32 low BM32 high Placebo
    Started
    53
    60
    53
    Completed
    47
    49
    45
    Not completed
    6
    11
    8
         Consent withdrawn by subject
    4
    3
    3
         Adverse event, non-fatal
    -
    2
    -
         Pregnancy
    -
    1
    1
         Concomitant disease
    -
    1
    -
         Lost to follow-up
    2
    1
    4
         non-compliant with study protocol
    -
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BM32 low
    Reporting group description
    		 BM32 0,2mg/mL

    Reporting group title
    BM32 high
    Reporting group description
    		 BM32 0,4 mg/mL

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 BM32 low BM32 high Placebo Total
    Number of subjects
    		 53 60 53 166
    Age categorical
    Units: Subjects
        Adults 18-64
    		 53 60 53 166
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 28.7 (18 to 53) 29.8 (18 to 52) 29.1 (18 to 58) -
    Gender categorical
    Units: Subjects
        Female
    		 19 24 22 65
        Male
    		 34 36 31 101
    Subject analysis sets

    Subject analysis set title
    BM32 Pooled
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with BM32 low and Placebo, who completed diary in treatment year 2 . Patients who previously have been treated with BM32 high dose in year 1 have been switched to BM32 low dose in year 2 and analysed together as Treatment Group "BM32 pooled"

    Subject analysis sets values
    		 BM32 Pooled
    Number of subjects
    92
    Age categorical
    Units: Subjects
        Adults 18-64
    92
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    BM32 low
    Reporting group description
    		 BM32 0,2mg/mL

    Reporting group title
    BM32 high
    Reporting group description
    		 BM32 0,4 mg/mL

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    BM32 Pooled
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with BM32 low and Placebo, who completed diary in treatment year 2 . Patients who previously have been treated with BM32 high dose in year 1 have been switched to BM32 low dose in year 2 and analysed together as Treatment Group "BM32 pooled"

    Primary: SMS Differences in Treatment Year 1

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    End point title
    		 SMS Differences in Treatment Year 1
    End point description
    End point type
    Primary
    End point timeframe
    Mean daily SMS during the peak pollen season in Treatment Year 1
    End point values
    		 BM32 low BM32 high Placebo
    Number of subjects analysed
    46
    52
    47
    Units: score
        least squares mean (confidence interval 95%)
    6.480 (5.349 to 7.611)
    6.930 (5.931 to 8.132)
    7.782 (6.244 to 9.320)
    Statistical analysis title
    		 SMS BM32 low vs Placebo (ANOVA)
    Comparison groups
    BM32 low v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.1537
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.05
         upper limit
    		 0.49
    Variability estimate
    Standard deviation
    Notes
    [1] - Comparison of treatment vs placebo
    Statistical analysis title
    		 SMS BM32 high vs Placebo (ANOVA)
    Comparison groups
    BM32 high v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.2877
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.63
         upper limit
    		 0.79
    Variability estimate
    Standard deviation
    Notes
    [2] - Comparison Treated vs Placebo

    Primary: SMS in Treatment Year 2

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    End point title
    		 SMS in Treatment Year 2 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Mean daily SMS during the peak pollen season in Treatment Year 1
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Based on results of the interim analysis patients, who have received high dose (BM32 high) in the first treatment year have been switched to the lower dose (BM32 low) in the second treatment year. Consequently, all patients receiving BM32 in the second year were analysed together as Treatment Group "BM32 pooled"
    End point values
    		 Placebo BM32 Pooled
    Number of subjects analysed
    45
    88
    Units: Score
        least squares mean (confidence interval 95%)
    7.812 (6.602 to 9.422)
    6.601 (5.869 to 7.437)
    Statistical analysis title
    		 SMS BM32 pooled vs Placebo (ANOVA)
    Comparison groups
    Placebo v BM32 Pooled
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.0847
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.74
         upper limit
    		 0.18
    Variability estimate
    Standard deviation
    Notes
    [4] - Comparison Treatment vs Placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the whole study from V1 (screeening) up to V17
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Safety Analysis Set (SA)
    Reporting group description
    		 -

    Reporting group title
    BM32 Low
    Reporting group description
    		 BM32 0,2mg/mL

    Reporting group title
    BM32 High
    Reporting group description
    		 BM32 0,4mg/mL

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Analysis Set (SA) BM32 Low BM32 High Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 166 (4.82%)
    2 / 53 (3.77%)
    5 / 60 (8.33%)
    1 / 53 (1.89%)
         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
    Clavicula fracture
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (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
    Ligamant rupture
    Additional description: Skiing accident
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (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
    Meniscus injury
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (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
    Ligament sprain
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (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
    Laceration of arm
    Additional description: Road traffic accident
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
         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
    Back injury
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
         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
    Accident
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (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
    Road Traffic Accident
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
         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
    Surgical and medical procedures
    Appendectomy
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (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
    Nervous system disorders
    Central nervous system inflammation
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 53 (1.89%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 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
    1 / 166 (0.60%)
    1 / 53 (1.89%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 53 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 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
    		 Safety Analysis Set (SA) BM32 Low BM32 High Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    153 / 166 (92.17%)
    50 / 53 (94.34%)
    56 / 60 (93.33%)
    47 / 53 (88.68%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 166 (15.66%)
    8 / 53 (15.09%)
    10 / 60 (16.67%)
    8 / 53 (15.09%)
         occurrences all number
    53
    18
    18
    17
    General disorders and administration site conditions
    Injection site swelling
         subjects affected / exposed
    120 / 166 (72.29%)
    41 / 53 (77.36%)
    47 / 60 (78.33%)
    32 / 53 (60.38%)
         occurrences all number
    424
    144
    179
    101
    Injection site erythema
         subjects affected / exposed
    112 / 166 (67.47%)
    39 / 53 (73.58%)
    48 / 60 (80.00%)
    25 / 53 (47.17%)
         occurrences all number
    426
    151
    187
    88
    Injection site pruritus
         subjects affected / exposed
    77 / 166 (46.39%)
    30 / 53 (56.60%)
    37 / 60 (61.67%)
    10 / 53 (18.87%)
         occurrences all number
    222
    97
    110
    15
    Injection site discomfort
         subjects affected / exposed
    39 / 166 (23.49%)
    13 / 53 (24.53%)
    13 / 60 (21.67%)
    13 / 53 (24.53%)
         occurrences all number
    103
    28
    32
    43
    Injection site pain
         subjects affected / exposed
    36 / 166 (21.69%)
    9 / 53 (16.98%)
    10 / 60 (16.67%)
    17 / 53 (32.08%)
         occurrences all number
    52
    10
    17
    25
    Injection site urticaria
         subjects affected / exposed
    33 / 166 (19.88%)
    16 / 53 (30.19%)
    17 / 60 (28.33%)
    0 / 53 (0.00%)
         occurrences all number
    59
    27
    32
    0
    Injection site induration
         subjects affected / exposed
    25 / 166 (15.06%)
    8 / 53 (15.09%)
    8 / 60 (13.33%)
    9 / 53 (16.98%)
         occurrences all number
    32
    12
    8
    12
    Injection site reaction
         subjects affected / exposed
    18 / 166 (10.84%)
    3 / 53 (5.66%)
    7 / 60 (11.67%)
    8 / 53 (15.09%)
         occurrences all number
    23
    3
    9
    11
    Injection site nodule
         subjects affected / exposed
    16 / 166 (9.64%)
    6 / 53 (11.32%)
    5 / 60 (8.33%)
    5 / 53 (9.43%)
         occurrences all number
    30
    9
    11
    10
    Injection site warmth
         subjects affected / exposed
    16 / 166 (9.64%)
    5 / 53 (9.43%)
    8 / 60 (13.33%)
    3 / 53 (5.66%)
         occurrences all number
    23
    8
    11
    4
    Injection site oedema
         subjects affected / exposed
    14 / 166 (8.43%)
    6 / 53 (11.32%)
    5 / 60 (8.33%)
    3 / 53 (5.66%)
         occurrences all number
    39
    18
    13
    8
    Pyrexia
         subjects affected / exposed
    9 / 166 (5.42%)
    2 / 53 (3.77%)
    4 / 60 (6.67%)
    3 / 53 (5.66%)
         occurrences all number
    9
    2
    4
    3
    Fatigue
         subjects affected / exposed
    5 / 166 (3.01%)
    0 / 53 (0.00%)
    2 / 60 (3.33%)
    3 / 53 (5.66%)
         occurrences all number
    6
    0
    2
    4
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 166 (1.81%)
    3 / 53 (5.66%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    4
    4
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 166 (4.82%)
    3 / 53 (5.66%)
    3 / 60 (5.00%)
    2 / 53 (3.77%)
         occurrences all number
    8
    3
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 166 (4.22%)
    3 / 53 (5.66%)
    3 / 60 (5.00%)
    1 / 53 (1.89%)
         occurrences all number
    7
    3
    3
    1
    Oropharyngeal pain
         subjects affected / exposed
    7 / 166 (4.22%)
    2 / 53 (3.77%)
    3 / 60 (5.00%)
    2 / 53 (3.77%)
         occurrences all number
    9
    2
    5
    2
    Dyspnoea
         subjects affected / exposed
    6 / 166 (3.61%)
    4 / 53 (7.55%)
    2 / 60 (3.33%)
    0 / 53 (0.00%)
         occurrences all number
    7
    4
    3
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    8 / 166 (4.82%)
    3 / 53 (5.66%)
    3 / 60 (5.00%)
    2 / 53 (3.77%)
         occurrences all number
    9
    3
    3
    3
    Rash
         subjects affected / exposed
    6 / 166 (3.61%)
    5 / 53 (9.43%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    7
    5
    0
    2
    Eczema
         subjects affected / exposed
    4 / 166 (2.41%)
    3 / 53 (5.66%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
         occurrences all number
    7
    4
    3
    0
    Musculoskeletal and connective tissue disorders
    Back injury
         subjects affected / exposed
    9 / 166 (5.42%)
    2 / 53 (3.77%)
    4 / 60 (6.67%)
    3 / 53 (5.66%)
         occurrences all number
    10
    2
    5
    3
    Arthralgia
         subjects affected / exposed
    3 / 166 (1.81%)
    0 / 53 (0.00%)
    3 / 60 (5.00%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    71 / 166 (42.77%)
    20 / 53 (37.74%)
    26 / 60 (43.33%)
    25 / 53 (47.17%)
         occurrences all number
    105
    33
    40
    32
    Rhinitis
         subjects affected / exposed
    15 / 166 (9.04%)
    7 / 53 (13.21%)
    6 / 60 (10.00%)
    2 / 53 (3.77%)
         occurrences all number
    18
    9
    7
    2
    Influenza
         subjects affected / exposed
    14 / 166 (8.43%)
    4 / 53 (7.55%)
    6 / 60 (10.00%)
    4 / 53 (7.55%)
         occurrences all number
    17
    4
    9
    4
    Tonsillitis
         subjects affected / exposed
    8 / 166 (4.82%)
    3 / 53 (5.66%)
    2 / 60 (3.33%)
    3 / 53 (5.66%)
         occurrences all number
    8
    3
    2
    3
    Gastroenteritis
         subjects affected / exposed
    7 / 166 (4.22%)
    2 / 53 (3.77%)
    3 / 60 (5.00%)
    2 / 53 (3.77%)
         occurrences all number
    8
    2
    4
    2
    Bronchitis
         subjects affected / exposed
    6 / 166 (3.61%)
    5 / 53 (9.43%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    6
    5
    0
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 166 (3.61%)
    2 / 53 (3.77%)
    1 / 60 (1.67%)
    3 / 53 (5.66%)
         occurrences all number
    9
    4
    1
    4
    Sinusitis
         subjects affected / exposed
    5 / 166 (3.01%)
    3 / 53 (5.66%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
         occurrences all number
    6
    3
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2012
    Amendment 1: Changes requested by the German Authorities (Paul-Ehrlich-Institut) have been implemented: - further details to the Exclusion-Criteria (No. 1, 10, 13,14 and 15) and a new exclusion criterion « patients with nasal polyposis » have been added - further detailed explanations for definitions and procedures have been given - correction of typos have been made
    05 Jul 2013
    Amendment 2: - Administrative changes have been done ( change in name of Pharmacovigilance). - The background of the study has been revised. - An Interim analysis after the first treatment year has been added. - Some Wordings have been corrected
    05 Jul 2013
    Amendment 3: Based of the result of interim analysis the advice of the IDMC was to continue the study but to switch patients, who have received high dose (40 µg per API) in the first treatment year to the lower dose (20µg of API) in the second treatment year and thus, skip the high dose arm. As a consequence the statistical part of the protocol had to be updated.

    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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