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    Clinical Trial Results:
    Double-blind, double-dummy, multi-center, randomized parallel group trial to demonstrate therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 μg/50 μg per actuation) versus Seretide 50 (25 μg/50 μg per actuation) over a period of 12 weeks in pediatric patients aged 4-11 years with persistent moderate asthma

    Summary
    EudraCT number
    		 2007-000135-26
    Trial protocol
    		 LT  
    Global end of trial date
    05 Jun 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Mar 2016
    First version publication date
    11 Feb 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Information about Articel 46 was not correct

    Trial information

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    Trial identification
    Sponsor protocol code
    2006-04-DOS-2
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Sep 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the long-term efficacy and safety of Salmeterol/Fluticasone MDI HEXAL 25 μg/50 μg per actuation compared to SeretideTM 50 (25 μg/50 μg per actuation) in pediatric patients suffering from persistent moderate asthma.
    Protection of trial subjects
    The trial was conducted in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP), Good Manufacturing Practice (GMP), the ethical principles of the Declaration of Helsinki and with applicable local regulations. Adverse events were systematically collected during the trial. During the trial subjects were allowed to use reliever medications for any asthma exacerbations under close medical control by physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2007
    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
    Lithuania: 51
    Country: Number of subjects enrolled
    Romania: 35
    Country: Number of subjects enrolled
    Ukraine: 260
    Worldwide total number of subjects
    346
    EEA total number of subjects
    86
    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)
    346
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Double-blind, double-dummy, multi-center, randomized parallel group trial in pediatric patients aged 4-11 years with persistent moderate asthma.

    Pre-assignment
    Screening details
    		 A total number of 360 patients where screened and 346 patients were randomized. The study consisted of a 2-week run-in period and a 12-week blinded treatment period (14 weeks in total). A screening visit (Visit -1) was followed by a 2-week run-in period during which all asthma treatments except reliever medication were stopped.

    Pre-assignment period milestones
    Number of subjects started
    		 360 [1]
    Number of subjects completed
    		 346

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 7
    Reason: Number of subjects
    		 Ineligibility: 6
    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: 14 patients dropped out according to protocol.
    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 MDI HEXAL
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/Fluticasone MDI HEXAL
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salmeterol/Fluticasone MDI HEXAL (25 μg/50μg of salmeterol/fluticasone per actuation), 2x2 actuations per day

    Arm title
    		 Seretide
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide 50 Evohaler
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Seretide 50 Evohaler (25 μg/50 μg per actuation), 2x2 actuations per day

    Number of subjects in period 1
    		Salmeterol/Fluticasone MDI HEXAL Seretide
    Started
    176
    170
    Completed
    172
    168
    Not completed
    4
    2
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL
    Reporting group description
    		 -

    Reporting group title
    Seretide
    Reporting group description
    		 -

    Reporting group values
    		 Salmeterol/Fluticasone MDI HEXAL Seretide Total
    Number of subjects
    		 176 170 346
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0
        Newborns (0-27days)
    		 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0
        Children (2-11 years)
    		 176 170 346
        Adolescents (12-17 year)
    		 0 0 0
        From 18 - 64 years
    		 0 0 0
        From 65 – 84 years
    		 0 0 0
        Over 85 years
    		 0 0 0
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 8.3 ( 1.9 ) 8.4 ( 1.9 ) -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 51 59 110
        Male
    		 125 111 236

    End points

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    End points reporting groups
    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL
    Reporting group description
    		 -

    Reporting group title
    Seretide
    Reporting group description
    		 -

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL (4-5 years) - 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 IP

    Subject analysis set title
    Seretide (4-5 years) - 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 IP

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - 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 IP

    Subject analysis set title
    Seretide (6-11 years) - 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 IP

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL (4-5 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety analysis set and had post-baseline FEV1 data

    Subject analysis set title
    Seretide (4-5 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety analysis set and had post-baseline FEV1 data

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety analysis set and had post-baseline FEV1 data

    Subject analysis set title
    Seretide (6-11 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety analysis set and had post-baseline FEV1 data

    Subject analysis set title
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FA set and completed the study and had no major protocol violations

    Subject analysis set title
    Seretide (6-11 years) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FA set and completed the study and had no major protocol violations

    Primary: FEV1 at Visit 4 compared with baseline (Visit 0)

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    End point title
    		 FEV1 at Visit 4 compared with baseline (Visit 0)
    End point description
    The change from baseline at the end of the 12 weeks treatment period. Missing values of the primary endpoint ‘change in FEV1’ were replaced using the last-value-carried forward strategy as follows, e.g. in case the FEV1 value was missing at Visit 4, the last value observed under treatment before Visit 4 was imputed as Visit 4 value. If there is no such last value under treatment, no imputation was made.
    End point type
    Primary
    End point timeframe
    From baseline to End of 12 weeks treatment period
    End point values
    		 Salmeterol/Fluticasone MDI HEXAL (6-11 years) - FAS Seretide (6-11 years) - FAS Salmeterol/Fluticasone MDI HEXAL (6-11 years) - PPS Seretide (6-11 years) - PPS
    Number of subjects analysed
    162
    162
    154
    151
    Units: Litre
    arithmetic mean (standard deviation)
        Baseline, FEV1
    1.415 ( 0.32 )
    1.468 ( 0.361 )
    1.42 ( 0.311 )
    1.457 ( 0.35 )
        Endpoint, FEV1
    1.86 ( 0.447 )
    1.973 ( 0.498 )
    1.873 ( 0.442 )
    1.971 ( 0.472 )
        Change from Baseline
    0.445 ( 0.287 )
    0.505 ( 0.267 )
    0.454 ( 0.289 )
    0.513 ( 0.25 )
    Statistical analysis title
    		 Mean Relative Change in FEV1 (FA set)
    Statistical analysis description
    Analysis of covariance (ANCOVA) was applied including treatment group and center as factors and the baseline value as a covariate in the statistical model in order to calculate a one-sided 97.5% confidence interval for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - FAS v Seretide (6-11 years) - FAS
    Number of subjects included in analysis
    324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9641
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.035051
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.073225
         upper limit
    		 -
    Statistical analysis title
    		 Mean Relative Change in FEV1 (PP set)
    Statistical analysis description
    Analysis of covariance (ANCOVA) was applied including treatment group and center as factors and the baseline value as a covariate in the statistical model in order to calculate a one-sided 97.5% confidence interval for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - PPS v Seretide (6-11 years) - PPS
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9632
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.035511
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.074444
         upper limit
    		 -

    Primary: Area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week study period (Visit 4) relative to baseline FEV1 (Visit 0)

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    End point title
    		 Area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week study period (Visit 4) relative to baseline FEV1 (Visit 0)
    End point description
    The area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week study period (Visit 4) relative to baseline FEV1 (Visit 0). Missing values of the second primary endpoint ‘AUC0-4’ were replaced using linear interpolation.
    End point type
    Primary
    End point timeframe
    From baseline to End of 12 weeks treatment period
    End point values
    		 Salmeterol/Fluticasone MDI HEXAL (6-11 years) - FAS Seretide (6-11 years) - FAS Salmeterol/Fluticasone MDI HEXAL (6-11 years) - PPS Seretide (6-11 years) - PPS
    Number of subjects analysed
    162
    162
    154
    151
    Units: Litre
    arithmetic mean (standard deviation)
        FEV1 at Visit 0: Baseline
    1.415 ( 0.32 )
    1.468 ( 0.361 )
    1.42 ( 0.311 )
    1.457 ( 0.35 )
        FEV1 AUC0-4/4 at Visit 4/ET
    1.966 ( 0.462 )
    2.068 ( 0.499 )
    1.969 ( 0.457 )
    2.054 ( 0.47 )
        Ratio of FEV1 AUC0-4/4 and baseline FEV1
    1.406 ( 0.206 )
    1.413 ( 0.18 )
    1.411 ( 0.207 )
    1.418 ( 0.176 )
        Log of Ratio of FEV1 AUC0-4/4 and baseline FEV1
    0.33 ( 0.145 )
    0.338 ( 0.127 )
    0.334 ( 0.145 )
    0.342 ( 0.123 )
    Statistical analysis title
    		 AUC0-4 at Visit 4 relative to Baseline (FA set)
    Statistical analysis description
    The ANCOVA was performed on log-transformed data. Similar to the first primary efficacy variable ANCOVA was applied including treatment group and center as factors and the log-transformed baseline FEV1 value as a covariate in the statistical model in order to calculate a one-sided 97.5% confidence interval for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - FAS v Seretide (6-11 years) - FAS
    Number of subjects included in analysis
    324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8235
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of LS Means
    Point estimate
    0.986185
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 0.957553
         upper limit
    		 -
    Statistical analysis title
    		 AUC0-4 at Visit 4 relative to Baseline (PP set)
    Statistical analysis description
    The ANCOVA was performed on log-transformed data. Similar to the first primary efficacy variable ANCOVA was applied including treatment group and center as factors and the log-transformed baseline FEV1 value as a covariate in the statistical model in order to calculate a one-sided 97.5% confidence interval for the difference in treatment effects (based on the adjusted means).
    Comparison groups
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - PPS v Seretide (6-11 years) - PPS
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7962
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of LS Means
    Point estimate
    0.987412
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 0.958134
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first intake of investigational product (IP) till the 14 days after the last intake of IP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL (4-5 years) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Salmeterol/Fluticasone MDI HEXAL (6-11 years) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Seretide (6-11 years) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Seretide (4-5 years) - Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Salmeterol/Fluticasone MDI HEXAL (4-5 years) - Safety Set Salmeterol/Fluticasone MDI HEXAL (6-11 years) - Safety Set Seretide (6-11 years) - Safety Set Seretide (4-5 years) - Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (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
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 8 (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
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (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 MDI HEXAL (4-5 years) - Safety Set Salmeterol/Fluticasone MDI HEXAL (6-11 years) - Safety Set Seretide (6-11 years) - Safety Set Seretide (4-5 years) - Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 13 (38.46%)
    45 / 163 (27.61%)
    49 / 162 (30.25%)
    4 / 8 (50.00%)
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 163 (1.23%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Blood and lymphatic system disorders
    Thrombocythaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 163 (2.45%)
    2 / 162 (1.23%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 163 (1.23%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysphonia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    4 / 162 (2.47%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    3 / 162 (1.85%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Bronchitis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 163 (1.23%)
    2 / 162 (1.23%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Bronchopneumonia
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 163 (1.84%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Candidiasis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
    8 / 163 (4.91%)
    11 / 162 (6.79%)
    2 / 8 (25.00%)
         occurrences all number
    1
    8
    11
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    3 / 13 (23.08%)
    14 / 163 (8.59%)
    14 / 162 (8.64%)
    2 / 8 (25.00%)
         occurrences all number
    3
    15
    18
    3
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 163 (1.84%)
    1 / 162 (0.62%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 163 (1.84%)
    5 / 162 (3.09%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    6
    0
    Rhinitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Viral infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 163 (1.23%)
    3 / 162 (1.85%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2007
    Amendment #1 Revised text: Minor grammatical and/or administrative changes have been made. Purpose for change: To improve the readability and/or clarity of the protocol.
    13 Dec 2007
    Amendment #2 The main reason for this amendment is to include a 16-hour urine collection at the end of the treatment period for the determination of urinary free cortisol levels as an additional safety parameter.

    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
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