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    Clinical Trial Results:
    Randomised, double-blind, double-dummy, parallel-group, comparative study of salmeterol/FP 50/100mcg bd inhalation powder via Diskus with oral Montelukast (5mg QD) chewable tablets in Children 6-14 years.

    Summary
    EudraCT number
    		 2015-004898-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    30 Apr 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2016
    First version publication date
    28 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SAM103848
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex,, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    06 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary study objective was to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate (SFC) compared with montelukast in the management of persistent asthma in children aged 6-14 years. Please note: In the age table the actual number of adolescent (between the ages of 12-17) participants is 90 participants. Two participants were missing age information from all study demographic tables, with no clear explanation about why that data was missing. Because the system does not allow us to note missing information, the 2 participants of unknown age were added to the adolescent age category.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 2005
    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
    Mexico: 163
    Country: Number of subjects enrolled
    Peru: 113
    Country: Number of subjects enrolled
    Argentina: 97
    Country: Number of subjects enrolled
    Costa Rica: 92
    Country: Number of subjects enrolled
    Ecuador: 32
    Country: Number of subjects enrolled
    Venezuela, Bolivarian Republic of: 24
    Country: Number of subjects enrolled
    Colombia: 20
    Country: Number of subjects enrolled
    Turkey: 7
    Worldwide total number of subjects
    548
    EEA total number of subjects
    0
    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)
    456
    Adolescents (12-17 years)
    92
    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
    		 This study was conducted from 08 Dec 2005 to 30 Apr 2007 at 27 centres across 8 countries.

    Pre-assignment
    Screening details
    		 A total of 607 participants were screened and 548 participants were enrolled in the study. During run in period, participants received salbutamol metered dose inhaler (MDI) for 2 weeks

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg
    Arm description
    		 During treatment period, participants received 1 inhalation of salmeterol/fluticasone propionate (SALM/ FP) 50/100 micrograms (mcg) dry powder inhaler (DPI) twice daily (BID) plus placebo for montelukast 5 milligram (mg) chewable tablet once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/Fluticasone propionate (SALM/FP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    One oral inhalation of 50/100 mcg of SFC via dry powder inhaler twice daily (morning and evening)

    Arm title
    		 Montelukast 5 mg once daily
    Arm description
    		 During treatment period, participants received montlukast 5 mg chewable tablet once daily plus a placebo for SALM/FP 50/100 mcg DPI BID for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One chewable tablet 5 mg orally once daily (evening)

    Number of subjects in period 1
    		Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Started
    281
    267
    Completed
    263
    244
    Not completed
    18
    23
         Consent withdrawn by subject
    4
    3
         Asthma exacerbation
    -
    7
         Adverse event, non-fatal
    2
    3
         Unspecified
    4
    2
         Lost to follow-up
    5
    3
         Protocol deviation
    3
    4
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg
    Reporting group description
    		 During treatment period, participants received 1 inhalation of salmeterol/fluticasone propionate (SALM/ FP) 50/100 micrograms (mcg) dry powder inhaler (DPI) twice daily (BID) plus placebo for montelukast 5 milligram (mg) chewable tablet once daily for 12 weeks.

    Reporting group title
    Montelukast 5 mg once daily
    Reporting group description
    		 During treatment period, participants received montlukast 5 mg chewable tablet once daily plus a placebo for SALM/FP 50/100 mcg DPI BID for 12 weeks.

    Reporting group values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily Total
    Number of subjects
    		 281 267
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.3 ± 2.15 9.3 ± 2.12 -
    Gender categorical
    Units:
        Female
    		 125 88 213
        Male
    		 156 179 335
    Race, Customized
    Units: Subjects
        White
    		 27 28 55
        Black
    		 1 1 2
        Asian
    		 1 0 1
        American Hispanic
    		 233 225 458
        Other
    		 19 13 32

    End points

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    End points reporting groups
    Reporting group title
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg
    Reporting group description
    		 During treatment period, participants received 1 inhalation of salmeterol/fluticasone propionate (SALM/ FP) 50/100 micrograms (mcg) dry powder inhaler (DPI) twice daily (BID) plus placebo for montelukast 5 milligram (mg) chewable tablet once daily for 12 weeks.

    Reporting group title
    Montelukast 5 mg once daily
    Reporting group description
    		 During treatment period, participants received montlukast 5 mg chewable tablet once daily plus a placebo for SALM/FP 50/100 mcg DPI BID for 12 weeks.

    Subject analysis set title
    SALM/FP 50/100 mcg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    . During treatment period, participants received 1 inhalation of salmeterol/fluticasone propionate (SALM/ FP) 50/100 micrograms (mcg) dry powder inhaler (DPI) twice daily (BID) plus placebo for montelukast 5 milligram (mg) chewable tablet once daily for 12 weeks.

    Subject analysis set title
    Montelukast 5 mg once daily
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    During treatment period, participants received montlukast 5 mg chewable tablet once daily plus a placebo for SALM/FP 50/100 mcg DPI BID for 12 weeks.

    Primary: Change from Baseline (Week-1) in mean morning peak expiratory flow rate (PEFR) over Weeks 1 to 12

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    End point title
    		 Change from Baseline (Week-1) in mean morning peak expiratory flow rate (PEFR) over Weeks 1 to 12
    End point description
    PEFR is defined as the maximum airflow generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the highest value of the three readings recorded in the morning of each day on a diary card for each participant using spirometry. Change from Baseline in PEFR was calculated as the PEFR individual on treatment values time point minus the Baseline value. Baseline is defined as the mean of the non missing daily values over the final seven days of the two-week run-in prior to randomisation.
    End point type
    Primary
    End point timeframe
    Baseline and up to Week 12
    End point values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Number of subjects analysed
    260 [1]
    253 [2]
    Units: Liter per minute (L/min)
        least squares mean (standard error)
    45.8 ± 2.82
    28.7 ± 2.86
    Notes
    [1] - ITT population
    [2] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    PEFR (morning) SALM/FP 50/100 mcg vs Montelukast 5 mg once daily
    Comparison groups
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg v Montelukast 5 mg once daily
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.23
         upper limit
    		 25.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.03

    Secondary: Change from Baseline in morning pre-dose FEV1 at Week 12 Last observation carried forward (LOCF).

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    End point title
    		 Change from Baseline in morning pre-dose FEV1 at Week 12 Last observation carried forward (LOCF).
    End point description
    FEV1 is defined as the volume of air forcefully expelled from lungs in one second. Change from baseline in pre dose FEV1 is the pre dose FEV1 value at a defined time point minus the Baseline (Visit 2) FEV1 value. Adjusted mean FEV1 values were calculated. Data is presented for the participants available at the time of assessment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Number of subjects analysed
    264 [3]
    245 [4]
    Units: Liters
        least squares mean (standard error)
    0.47 ± 0.017
    0.3 ± 0.018
    Notes
    [3] - ITT population
    [4] - ITT population
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    FEV1 SALM/FP 50/100 mcg vs Montelukast 5 mg once daily
    Comparison groups
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg v Montelukast 5 mg once daily
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025

    Secondary: Percent change from Baseline in morning pre dose forced expiratory volume in 1 second (FEV1) at Week 12

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    End point title
    		 Percent change from Baseline in morning pre dose forced expiratory volume in 1 second (FEV1) at Week 12
    End point description
    FEV1 is the volume of air exhaled in first second of forced spirometry test. Change from baseline in pre-dose FEV1 is the pre dose FEV1 value at a defined time point minus the Baseline (Visit 2) FEV1 value. Adjusted mean FEV1 values were calculated and expressed as percentage change. Data is presented for the participants available at the time of assessment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Number of subjects analysed
    264 [5]
    245 [6]
    Units: Percent change
        least squares mean (standard error)
    33.83 ± 1.22
    22.08 ± 1.267
    Notes
    [5] - ITT population
    [6] - ITT population
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Percent Change FEV1 SALM/FP 50/100 mcg vs Montelukast 5 mg once daily
    Comparison groups
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg v Montelukast 5 mg once daily
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.28
         upper limit
    		 15.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.767

    Secondary: Change from Baseline in mean evening peak expiratory flow rate (PEFR) over weeks 1 to 12

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    End point title
    		 Change from Baseline in mean evening peak expiratory flow rate (PEFR) over weeks 1 to 12
    End point description
    PEFR is defined as the maximum airflow generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the highest value of the three readings recorded in evening of each day on diary cards for each participant using spirometry. Change from Baseline in PEFR is the PEFR value at a defined time point minus the Baseline value. Data is presented for participants available at the time of assessment.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 12
    End point values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Number of subjects analysed
    261 [7]
    253 [8]
    Units: L/min
        least squares mean (standard error)
    46.2 ± 2.84
    27.8 ± 2.89
    Notes
    [7] - ITT population
    [8] - ITT population
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    PEFR (evening) SALM/FP 50/100 mcg vs Montelukast 5 mg once daily
    Comparison groups
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg v Montelukast 5 mg once daily
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.35
         upper limit
    		 26.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.071

    Secondary: Number of participants in each category of change in percentage of symptom free 24 hour periods from Baseline toWeeks 1 to 12

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    End point title
    		 Number of participants in each category of change in percentage of symptom free 24 hour periods from Baseline toWeeks 1 to 12
    End point description
    A symptom free 24 hour period is one during which the diary recorded daytime and night time symptom score is zero. Participants were asked to rate the day time asthma symptom scores on a scale of 0 5 (0=no symptoms, 1=symptoms with no discomfort, 2=symptoms with discomfort without affecting daily normal activities, 3=symptoms with discomfort affecting daily normal activities, 4=symptoms with discomfort affecting 2 or more normal daily activities, 5=symptoms with discomfort affecting normal daily activities) and night time asthma symtpoms on a scale of 0 3 (0=no symptoms, 1 3= rating was based on increased awakening during night). The 24 hour period asthma symptom scores were the sum of the daytime and night time symptom scores recorded on diary card. The percentage of symptoms were classified as 0 <25%, 25 <50%, 50 <75%, 75 <100% and 100%.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 12
    End point values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Number of subjects analysed
    281 [9]
    267 [10]
    Units: Participants
        Baseline, 0 to <25%
    189
    176
        Baseline, 25 to <50%
    35
    59
        Baseline, 50 to <75%
    26
    14
        Baseline, 75 to <100%
    6
    2
        Baseline, 100%
    7
    4
        Weeks 1 to 12, 0 to <25%
    34
    40
        Weeks 1 to 12, 25 to <50%
    20
    46
        Weeks 1 to 12, 50 to <75%
    57
    58
        Weeks 1 to 12, 75 to <100%
    128
    99
        Weeks 1 to 12, 100%
    23
    11
    Notes
    [9] - ITT population
    [10] - ITT population
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Symptom free 24 hour periods SALM/FP 50/100 mcg vs Montelukast 5 mg once daily
    Comparison groups
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg v Montelukast 5 mg once daily
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.82

    Secondary: Number of participants in each category of change in percentage of rescue medication free 24 hour periods from Baseline to Weeks 1 to 12

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    End point title
    		 Number of participants in each category of change in percentage of rescue medication free 24 hour periods from Baseline to Weeks 1 to 12
    End point description
    A rescue medication free 24 hour period is one in which the daytime and night time rescue medication (salbutamol) use recorded in diary cards is zero. The total number of occassions of using rescue medication was calculated. The percentage of rescue medication use was classified as 0 to <25%, 25 to <50%, 50 to <75%, 75 to <100% and 100%.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg Montelukast 5 mg once daily
    Number of subjects analysed
    281 [11]
    267 [12]
    Units: Participants
        Baseline, 0 to <25%
    187
    195
        Baseline, 25 to <50%
    54
    39
        Baseline, 50 to <75%
    12
    14
        Baseline, 75 to <100%
    4
    1
        Baseline, 100%
    2
    2
        Weeks 1 to 12, 0 to <25%
    40
    69
        Weeks 1 to 12, 25 to <50%
    10
    21
        Weeks 1 to 12, 50 to <75%
    46
    55
        Weeks 1 to 12, 75 to <100%
    132
    80
        Weeks 1 to 12, 100%
    24
    15
    Notes
    [11] - ITT population
    [12] - ITT population
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Rescue medication free 24 hour periods SALM/FP 50/100 mcg vs Montelukast 5 mg once daily
    Comparison groups
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg v Montelukast 5 mg once daily
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.09
         upper limit
    		 5.02

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious adverse events were collected from the start of study treatment to the end of study treatment (up to 12 weeks)
    Adverse event reporting additional description
    ITT population
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    Montelukast 5 mg once daily
    Reporting group description
    		 During treatment period, participants received montlukast 5 mg chewable tablet once daily plus a placebo for SALM/FP 50/100 mcg DPI BID for 12 weeks.

    Reporting group title
    Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg
    Reporting group description
    		 . During treatment period, participants received 1 inhalation of salmeterol/fluticasone propionate (SALM/ FP) 50/100 micrograms (mcg) dry powder inhaler (DPI) twice daily (BID) plus placebo for montelukast 5 milligram (mg) chewable tablet once daily for 12 weeks.

    Serious adverse events
    		 Montelukast 5 mg once daily Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 267 (0.75%)
    0 / 281 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Montelukast 5 mg once daily Salmeterol/Fluticasone propionate (SALM/FP) 50/100 mcg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    120 / 267 (44.94%)
    128 / 281 (45.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    72 / 267 (26.97%)
    66 / 281 (23.49%)
         occurrences all number
    153
    123
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    18 / 267 (6.74%)
    24 / 281 (8.54%)
         occurrences all number
    22
    28
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 267 (4.87%)
    9 / 281 (3.20%)
         occurrences all number
    16
    9
    Vomiting
         subjects affected / exposed
    12 / 267 (4.49%)
    7 / 281 (2.49%)
         occurrences all number
    15
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    16 / 267 (5.99%)
    13 / 281 (4.63%)
         occurrences all number
    21
    18
    Rhinitis allergic
         subjects affected / exposed
    10 / 267 (3.75%)
    13 / 281 (4.63%)
         occurrences all number
    17
    23
    Rhinorrhoea
         subjects affected / exposed
    8 / 267 (3.00%)
    15 / 281 (5.34%)
         occurrences all number
    10
    22
    Pharyngolaryngeal pain
         subjects affected / exposed
    6 / 267 (2.25%)
    11 / 281 (3.91%)
         occurrences all number
    7
    13
    Epistaxis
         subjects affected / exposed
    1 / 267 (0.37%)
    10 / 281 (3.56%)
         occurrences all number
    1
    13
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    17 / 267 (6.37%)
    17 / 281 (6.05%)
         occurrences all number
    21
    17
    Nasopharyngitis
         subjects affected / exposed
    8 / 267 (3.00%)
    14 / 281 (4.98%)
         occurrences all number
    8
    17
    Sinusitis
         subjects affected / exposed
    13 / 267 (4.87%)
    9 / 281 (3.20%)
         occurrences all number
    13
    9
    Influenza
         subjects affected / exposed
    9 / 267 (3.37%)
    7 / 281 (2.49%)
         occurrences all number
    15
    7
    Tonsillitis
         subjects affected / exposed
    9 / 267 (3.37%)
    5 / 281 (1.78%)
         occurrences all number
    11
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2005
    The study was divided into two phases: I and II. During the study, more subjects had to be recruited. However, the recruitment of subjects could not be achieved prior to the expiry date of the batch of clinical supplies. Therefore, a re-supply was required, which resulted in a second phase of the study.

    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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