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    Clinical Trial Results:
    Efficacy and safety of Salmeterol/Fluticasone DPI HEXAL versus SeretideTM AccuhalerTM in adolescent and adult patients with moderate-to-severe persistent asthma: A 12-week, multicenter, randomized, double-blind, double-dummy, parallel group study

    Summary
    EudraCT number
    		 2007-005620-32
    Trial protocol
    		 HU   LT   PL  
    Global end of trial date
    22 Feb 2010

    Results information
    Results version number
    		 v1
    This version publication date
    10 Feb 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    2006-56-DPI-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HEXAL AG
    Sponsor organisation address
    Industriestraße 25, Holzkirchen, Germany, 83607
    Public contact
    Head of Clinical Research Department, Hexal AG, 0049 80249080,
    Scientific contact
    Head of Clinical Research Department, Hexal AG, 0049 80249080,
    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
    10 Nov 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the long-term efficacy and safety of Salmeterol/Fluticasone DPI HEXAL compared to SeretideTM AccuhalerTM in adolescent and adult patients suffering from moderate-to-severe persistent asthma.
    Protection of trial subjects
    Safety assessments included adverse events (AEs), physical examination, ECG, vital signs and clinical laboratory data. This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2009
    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
    Hungary: 42
    Country: Number of subjects enrolled
    Lithuania: 37
    Country: Number of subjects enrolled
    Poland: 156
    Country: Number of subjects enrolled
    Romania: 127
    Country: Number of subjects enrolled
    Ukraine: 193
    Worldwide total number of subjects
    555
    EEA total number of subjects
    362
    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)
    48
    Adults (18-64 years)
    506
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A 12-week, multicenter, randomized, double-blind, double-dummy, parallel group study in adolescent and adult patients with moderate-to-severe persistent asthma

    Pre-assignment
    Screening details
    		 A total number of 592 patients where screened and 555 patients were randomized. The study consisted of a 2-week run-in period and a 12-week blinded treatment period (14 weeks in total). The screening visit (Visit -1) was followed by a 2-week run-in period during which all asthma treatments except reliever medication were to be stopped.

    Pre-assignment period milestones
    Number of subjects started
    		 592 [1]
    Number of subjects completed
    		 555

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 2
    Reason: Number of subjects
    		 Adverse event, serious non-fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 6
    Reason: Number of subjects
    		 Pregnancy: 2
    Reason: Number of subjects
    		 Protocol deviation: 1
    Reason: Number of subjects
    		 Lost to follow-up: 1
    Reason: Number of subjects
    		 Ineligibility: 23
    Reason: Number of subjects
    		 Other: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Pre-assignment period includes all subjects screened. Worldwide period includes number of subjects treated.
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/Fluticasone DPI HEXAL
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salmeterol/Fluticasone DPI HEXAL (50 μg salmeterol/100 μg fluticasone per actuation), one actuation two times per day

    Arm title
    		 Seretide 100 Accuhaler
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide 100 Accuhaler
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Seretide 100 Accuhaler (50 μg salmeterol/100 μg fluticasone per actuation), one actuation two times per day

    Arm title
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/Fluticasone DPI HEXAL
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salmeterol/Fluticasone DPI HEXAL (50 μg salmeterol/500 μg fluticasone per actuation), one actuation two times per day

    Arm title
    		 Seretide 500 Accuhaler
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide 500 Accuhaler
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Seretide 500 Accuhaler (50 μg salmeterol/500 μg fluticasone per actuation), one actuation two times per day

    Number of subjects in period 1
    		Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) Seretide 100 Accuhaler Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) Seretide 500 Accuhaler
    Started
    139
    137
    136
    143
    Completed
    136
    131
    128
    138
    Not completed
    3
    6
    8
    5
         Consent withdrawn by subject
    1
    1
    3
    2
         The blind was broken
    -
    -
    2
    -
         Adverse event, non-fatal
    1
    1
    1
    1
         Lost to follow-up
    1
    4
    -
    1
         Protocol deviation
    -
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg)
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler
    Reporting group description
    		 -

    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg)
    Reporting group description
    		 -

    Reporting group title
    Seretide 500 Accuhaler
    Reporting group description
    		 -

    Reporting group values
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) Seretide 100 Accuhaler Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) Seretide 500 Accuhaler Total
    Number of subjects
    		 139 137 136 143 555
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0 0 0
        Newborns (0-27days)
    		 0 0 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 year)
    		 10 12 14 12 48
        From 18 - 64 years
    		 129 125 122 130 506
        From 65 – 84 years
    		 0 0 0 1 1
        Over 85 years
    		 0 0 0 0 0
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 45.9 ( 14.9 ) 45.5 ( 14.4 ) 43.8 ( 14.9 ) 45.6 ( 14.2 ) -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 92 77 83 76 328
        Male
    		 47 60 53 67 227

    End points

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    End points reporting groups
    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg)
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler
    Reporting group description
    		 -

    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg)
    Reporting group description
    		 -

    Reporting group title
    Seretide 500 Accuhaler
    Reporting group description
    		 -

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of one IP.

    Subject analysis set title
    Seretide 100 Accuhaler - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of one IP.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of one IP.

    Subject analysis set title
    Seretide 500 Accuhaler - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of one IP.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the SS and had clinic FEV1 data after the baseline visit

    Subject analysis set title
    Seretide 100 Accuhaler - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the SS and had clinic FEV1 data after the baseline visit

    Subject analysis set title
    Seretide 500 Accuhaler - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the SS and had clinic FEV1 data after the baseline visit

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the SS and had clinic FEV1 data after the baseline visit

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FAS and completed the study and had no major protocol violations.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FAS and completed the study and had no major protocol violations.

    Subject analysis set title
    Seretide 100 Accuhaler - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FAS and completed the study and had no major protocol violations.

    Subject analysis set title
    Seretide 500 Accuhaler - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FAS and completed the study and had no major protocol violations.

    Primary: Change in FEV1 from baseline to the end of treatment period

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    End point title
    		 Change in FEV1 from baseline to the end of treatment period
    End point description
    The absolute change in FEV1 from baseline at the end of the 12-week treatment period. Missing values of the primary endpoint ‘absolute change in FEV1’ were replaced using the last-value carried- forward strategy as follows: in case if both pre–dose FEV1 values was missing at Visit 6/ET, the last value observed under treatment before Visit 6/ET was imputed as Visit 6/ET value. If there is no such last value under treatment, no imputation was made. If there is only one assessment of FEV1 pre-dose values at Visit 0 or Visit 6/ET is done, the available value was used for analysis.
    End point type
    Primary
    End point timeframe
    End of 12 weeks treatment period
    End point values
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - PPS Seretide 100 Accuhaler - PPS Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - PPS Seretide 500 Accuhaler - PPS
    Number of subjects analysed
    134
    129
    127
    134
    Units: Litre
    arithmetic mean (standard deviation)
        Baseline, FEV1
    1.986 ( 0.514 )
    2.097 ( 0.537 )
    2.063 ( 0.509 )
    2.177 ( 0.538 )
        Endpoint, FEV1
    2.262 ( 0.699 )
    2.464 ( 0.776 )
    2.406 ( 0.696 )
    2.561 ( 0.812 )
        Absolute Change from Baseline
    0.276 ( 0.42 )
    0.367 ( 0.423 )
    0.344 ( 0.385 )
    0.384 ( 0.451 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) was applied including treatment group and center as factors, age and baseline FEV1 as covariables in the statistical model in order to calculate a two-sided 95% confidence interval (CI) for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - PPS v Seretide 100 Accuhaler - PPS
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.149
    Method
    		 ANCOVA
    Parameter type
    		 Mean Difference
    Point estimate
    -0.065446
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.154491
         upper limit
    		 0.0236
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Analysis of covariance (ANCOVA) was applied including treatment group and center as factors, age and baseline FEV1 as covariables in the statistical model in order to calculate a two-sided 95% confidence interval (CI) for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - PPS v Seretide 500 Accuhaler - PPS
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.482
    Method
    		 ANCOVA
    Parameter type
    		 Mean Difference
    Point estimate
    -0.032006
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.121478
         upper limit
    		 0.057465

    Primary: Area Under the 12-hour Serial FEV1 Curve (AUC0-12) Relative to the Mean Pre-inhalation FEV1 at Visit 6

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    End point title
    		 Area Under the 12-hour Serial FEV1 Curve (AUC0-12) Relative to the Mean Pre-inhalation FEV1 at Visit 6
    End point description
    The area under the 12-hour serial FEV1 curve (AUC0-12) at the end of the 12-week treatment period (Visit 6) relative to the mean FEV1 value at Visit 6 pre-inhalation. Missing values of the second primary endpoint ‘FEV1 AUC(0-12)’ were replaced using linear interpolation.
    End point type
    Primary
    End point timeframe
    At the end of the double blind treatment period
    End point values
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - PPS Seretide 100 Accuhaler - PPS Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - PPS Seretide 500 Accuhaler - PPS
    Number of subjects analysed
    134
    129
    127
    134
    Units: Litre
    arithmetic mean (standard deviation)
        FEV1 mean of the 2 pre-dose values at Visit 6/ET
    2.262 ( 0.699 )
    2.464 ( 0.776 )
    2.406 ( 0.696 )
    2.561 ( 0.812 )
        FEV1 AUC0-12/12
    2.369 ( 0.699 )
    2.561 ( 0.774 )
    2.539 ( 0.715 )
    2.654 ( 0.802 )
        Ratio of FEV1 AUC0-12/12 & pre-IP FEV1
    1.054 ( 0.09 )
    1.046 ( 0.075 )
    1.055 ( 0.078 )
    1.043 ( 0.082 )
        Log of the ratio of FEV1 AUC0-12/12 & pre-IP FEV1
    0.05 ( 0.082 )
    0.043 ( 0.069 )
    0.051 ( 0.072 )
    0.039 ( 0.073 )
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Analysis of covariance (ANCOVA)was applied including treatment group and center as factors, age and log transformed mean FEV1 pre-inhalation value as covariates in the statistical model in order to calculate a two-sided 95% confidence interval for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - PPS v Seretide 100 Accuhaler - PPS
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.902
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    1.001062
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.984215
         upper limit
    		 1.018198
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Analysis of covariance (ANCOVA)was applied including treatment group and center as factors, age and log transformed mean FEV1 pre-inhalation value as covariates in the statistical model in order to calculate a two-sided 95% confidence interval for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - PPS v Seretide 500 Accuhaler - PPS
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.333
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    1.008245
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.991557
         upper limit
    		 1.025214

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first intake of investigational product (IP) till the 4 weeks after the last intake of IP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Seretide 500 Accuhaler - Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - Safety Set Seretide 100 Accuhaler - Safety Set Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - Safety Set Seretide 500 Accuhaler - Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (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: 0%
    Non-serious adverse events
    		 Salmeterol/Fluticasone DPI HEXAL (50 μg/100 μg) - Safety Set Seretide 100 Accuhaler - Safety Set Salmeterol/Fluticasone DPI HEXAL (50 μg/500 μg) - Safety Set Seretide 500 Accuhaler - Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 139 (27.34%)
    31 / 137 (22.63%)
    33 / 136 (24.26%)
    35 / 143 (24.48%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    1
    0
    0
    1
    Hypertensive crisis
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    0
    0
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    5 / 139 (3.60%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    4 / 143 (2.80%)
         occurrences all number
    5
    1
    0
    4
    Tremor
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 139 (0.72%)
    2 / 137 (1.46%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    1
    2
    0
    1
    Nausea
         subjects affected / exposed
    1 / 139 (0.72%)
    2 / 137 (1.46%)
    2 / 136 (1.47%)
    1 / 143 (0.70%)
         occurrences all number
    1
    2
    2
    1
    Toothache
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 139 (2.16%)
    1 / 137 (0.73%)
    3 / 136 (2.21%)
    2 / 143 (1.40%)
         occurrences all number
    3
    1
    3
    2
    Dysphonia
         subjects affected / exposed
    3 / 139 (2.16%)
    4 / 137 (2.92%)
    6 / 136 (4.41%)
    2 / 143 (1.40%)
         occurrences all number
    3
    4
    6
    2
    Nasal congestion
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 137 (0.73%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Throat irritation
         subjects affected / exposed
    2 / 139 (1.44%)
    3 / 137 (2.19%)
    1 / 136 (0.74%)
    1 / 143 (0.70%)
         occurrences all number
    2
    3
    2
    1
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    1
    0
    0
    1
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 139 (0.72%)
    2 / 137 (1.46%)
    2 / 136 (1.47%)
    1 / 143 (0.70%)
         occurrences all number
    1
    2
    2
    1
    Candidiasis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 139 (0.00%)
    4 / 137 (2.92%)
    2 / 136 (1.47%)
    4 / 143 (2.80%)
         occurrences all number
    0
    4
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    6 / 139 (4.32%)
    6 / 137 (4.38%)
    5 / 136 (3.68%)
    4 / 143 (2.80%)
         occurrences all number
    6
    6
    5
    4
    Oral candidiasis
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    1 / 136 (0.74%)
    2 / 143 (1.40%)
         occurrences all number
    0
    1
    1
    2
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    1
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 139 (0.72%)
    2 / 137 (1.46%)
    1 / 136 (0.74%)
    2 / 143 (1.40%)
         occurrences all number
    1
    2
    1
    2
    Respiratory tract infection viral
         subjects affected / exposed
    4 / 139 (2.88%)
    3 / 137 (2.19%)
    1 / 136 (0.74%)
    4 / 143 (2.80%)
         occurrences all number
    4
    3
    1
    5
    Rhinitis
         subjects affected / exposed
    1 / 139 (0.72%)
    2 / 137 (1.46%)
    3 / 136 (2.21%)
    0 / 143 (0.00%)
         occurrences all number
    1
    2
    3
    0
    Sinusitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 137 (0.73%)
    3 / 136 (2.21%)
    6 / 143 (4.20%)
         occurrences all number
    2
    1
    3
    7
    Viral infection
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Viral rhinitis
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    1
    1
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 137 (0.73%)
    0 / 136 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 137 (0.00%)
    1 / 136 (0.74%)
    0 / 143 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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