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    Clinical Trial Results:
    SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma

    Summary
    EudraCT number
    		 2011-001644-29
    Trial protocol
    		 GB   AT   DE   ES   LT   SE   LV   HU   CZ   BE   NL   PL   IT   DK   SK   FI   BG  
    Global end of trial date
    23 Jun 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Dec 2016
    First version publication date
    12 Jun 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor change required to match changes to the ctgov version.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    115359
    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
    26 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 2011
    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
    United States: 5224
    Country: Number of subjects enrolled
    Canada: 79
    Country: Number of subjects enrolled
    Argentina: 401
    Country: Number of subjects enrolled
    Chile: 79
    Country: Number of subjects enrolled
    Colombia: 8
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Peru: 178
    Country: Number of subjects enrolled
    Austria: 47
    Country: Number of subjects enrolled
    Belgium: 22
    Country: Number of subjects enrolled
    Bulgaria: 263
    Country: Number of subjects enrolled
    Croatia: 19
    Country: Number of subjects enrolled
    Czech Republic: 217
    Country: Number of subjects enrolled
    Denmark: 29
    Country: Number of subjects enrolled
    Germany: 624
    Country: Number of subjects enrolled
    Hungary: 174
    Country: Number of subjects enrolled
    Italy: 86
    Country: Number of subjects enrolled
    Latvia: 106
    Country: Number of subjects enrolled
    Lithuania: 97
    Country: Number of subjects enrolled
    Poland: 551
    Country: Number of subjects enrolled
    Romania: 45
    Country: Number of subjects enrolled
    Russian Federation: 1035
    Country: Number of subjects enrolled
    Serbia: 183
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    Spain: 161
    Country: Number of subjects enrolled
    Ukraine: 480
    Country: Number of subjects enrolled
    United Kingdom: 59
    Country: Number of subjects enrolled
    South Africa: 951
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Indonesia: 227
    Country: Number of subjects enrolled
    Korea, Republic of: 131
    Country: Number of subjects enrolled
    Malaysia: 60
    Country: Number of subjects enrolled
    Philippines: 81
    Country: Number of subjects enrolled
    Taiwan: 31
    Worldwide total number of subjects
    11679
    EEA total number of subjects
    2503
    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)
    1230
    Adults (18-64 years)
    9181
    From 65 to 84 years
    1268
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study duration was 29 weeks, comprised of a randomization visit followed by a treatment period of 26 weeks and a 1-week follow-up phone call. Subjects were assessed for eligibility at screening up to 15 days prior to randomization.

    Pre-assignment
    Screening details
    		 Eligible adolescent and adult participants with asthma were stratified based on current asthma medication and a Asthma Control Questionnaire (ACQ-6) score and randomized 1:1 to double-blind study treatment. A total of 11751 were enrolled; however, 72 were randomized but did not receive study treatment.

    Period 1
    Period 1 title
    Overall Study (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
    		 Fluticasone propionate/salmeterol combination (FSC)
    Arm description
    		 Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone propionate/salmeterol combination (FSC) 100/50 mcg, FSC 250/50 mcg, and FSC 500/50 mcg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    One inhalation was administered via DPI twice daily (BID) (approximately 12 hours apart)

    Arm title
    		 Fluticasone propionate (FP)
    Arm description
    		 Participants received one of the following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation BID via DPI for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone Propionate (FP) 100 mcg, FP 250 mcg, FP 500 mcg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    One inhalation was administered via DPI twice daily (BID) (approximately 12 hours apart)

    Number of subjects in period 1
    		Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Started
    5834
    5845
    Completed
    5823
    5831
    Not completed
    11
    14
         Consent withdrawn by subject
    8
    8
         Death
    3
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol combination (FSC)
    Reporting group description
    		 Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.

    Reporting group title
    Fluticasone propionate (FP)
    Reporting group description
    		 Participants received one of the following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation BID via DPI for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.

    Reporting group values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP) Total
    Number of subjects
    		 5834 5845 11679
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.4 ± 17.45 43.4 ± 17.28 -
    Gender categorical
    Units: Subjects
        Female
    		 3851 3898 7749
        Male
    		 1983 1947 3930
    Customized, Race
    Units: Subjects
        Missing
    		 3 3 6
        African American/African Heritage
    		 870 856 1726
        American Indian/Alaska native
    		 109 116 225
        Asian-Central/South Asian Heritage
    		 36 45 81
        Asian-East Asian Heritage
    		 94 88 182
        Japanese Heritage
    		 4 3 7
        Asian-South East Asian Heritage
    		 234 224 458
        Native Hawaiian or other Pacific Islander
    		 8 10 18
        White-Arabic/North African Heritage
    		 22 21 43
        White-White/Caucasian/European Heritage
    		 4352 4388 8740
        Multiple
    		 102 91 193

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol combination (FSC)
    Reporting group description
    		 Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.

    Reporting group title
    Fluticasone propionate (FP)
    Reporting group description
    		 Participants received one of the following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation BID via DPI for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.

    Primary: Number of participants experiencing an event in the composite safety endpoint of serious asthma outcomes ( asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death)

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    End point title
    		 Number of participants experiencing an event in the composite safety endpoint of serious asthma outcomes ( asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death)
    End point description
    Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates. Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95. Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 26 weeks
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    5834
    5845
    Units: Participants
        number (not applicable)
    34
    33
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.003
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.029
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.638
         upper limit
    		 1.662
    Notes
    [1] - The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value <0.025.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Estimated for Absolute risk difference
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.0002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0026
         upper limit
    		 0.0029

    Primary: Number of participants experiencing at least one asthma exacerbation

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    End point title
    		 Number of participants experiencing at least one asthma exacerbation
    End point description
    An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 26 weeks
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    5834
    5845
    Units: Participants
        number (not applicable)
    480
    597
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.203
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.834
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.103
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.188
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.839
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.645
         upper limit
    		 1.09
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.764
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.645
         upper limit
    		 0.905
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.071
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.682
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.451
         upper limit
    		 1.034
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.373
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.878
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.659
         upper limit
    		 1.17
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.271
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.864
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.665
         upper limit
    		 1.122
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.755
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.637
         upper limit
    		 0.895
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy. The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.075
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.687
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.454
         upper limit
    		 1.04

    Secondary: Number of participants experiencing at least one asthma related hospitalization, endotracheal intubation and death

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    End point title
    		 Number of participants experiencing at least one asthma related hospitalization, endotracheal intubation and death
    End point description
    Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 26 weeks
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    5834 [2]
    5845 [3]
    Units: Participants
    number (not applicable)
        Hospitalization
    34
    33
        Endotracheal intubation
    0
    2
        Death
    0
    0
    Notes
    [2] - ITT Population
    [3] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participant withdrawals from study treatment due to asthma exacerbation

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    End point title
    		 Number of participant withdrawals from study treatment due to asthma exacerbation
    End point description
    An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 26 weeks
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    5834 [4]
    5845 [5]
    Units: Participants
        number (not applicable)
    66
    84
    Notes
    [4] - mITT Population
    [5] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11679
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.123
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.776
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.562
         upper limit
    		 1.071

    Secondary: Mean rescue medication (albuterol/salbutamol) use as puffs per 24 hours

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    End point title
    		 Mean rescue medication (albuterol/salbutamol) use as puffs per 24 hours
    End point description
    Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 26 weeks
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    5677 [6]
    5673 [7]
    Units: Number of Puffs
        arithmetic mean (standard error)
    0.9 ± 0.018
    1.09 ± 0.02
    Notes
    [6] - mITT Population. Only those participants available at specified timepoint were analysed.
    [7] - mITT Population. Only those participants available at specified timepoint were analysed.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11350
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.263
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.385
         upper limit
    		 -0.141
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11350
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Regression, Cox
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.222
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.369
         upper limit
    		 -0.076
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11350
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.172
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.238
         upper limit
    		 -0.106
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Efficacy subgroup: Subjects controlled on prior ICS therapy
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    11350
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.251
    Method
    		 Regression, Cox
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.216
         upper limit
    		 0.056

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
    Adverse event reporting additional description
    All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol combination (FSC)
    Reporting group description
    		 Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.

    Reporting group title
    Fluticasone propionate (FP)
    Reporting group description
    		 Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.

    Serious adverse events
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    134 / 5834 (2.30%)
    125 / 5845 (2.14%)
         number of deaths (all causes)
    3
    6
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaplastic astrocytoma
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 5834 (0.02%)
    4 / 5845 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blighted ovum
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 5834 (0.03%)
    4 / 5845 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergic granulomatous angiitis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Fallopian tube cyst
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cervical squamous metaplasia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Status asthmaticus
         subjects affected / exposed
    0 / 5834 (0.00%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 5834 (0.02%)
    5 / 5845 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    30 / 5834 (0.51%)
    28 / 5845 (0.48%)
         occurrences causally related to treatment / all
    2 / 32
    3 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Stress
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 5834 (0.00%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bulimia nervosa
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 5834 (0.02%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnambulism
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Coagulation time prolonged
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat exhaustion
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed recovery from anaesthesia
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hereditary angioedema
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 5834 (0.05%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 5834 (0.00%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 5834 (0.02%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal subdural haematoma
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 5834 (0.03%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    4 / 5834 (0.07%)
    3 / 5845 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hemiparesis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 5834 (0.05%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 5834 (0.00%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 5834 (0.03%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 5834 (0.02%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cyst
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 5834 (0.03%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 5834 (0.00%)
    3 / 5845 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 5834 (0.05%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 5834 (0.02%)
    2 / 5845 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Helicobacter gastritis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillitis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    8 / 5834 (0.14%)
    8 / 5845 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Salpingo-oophoritis
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viraemia
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 5834 (0.00%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 5834 (0.02%)
    1 / 5845 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 5834 (0.05%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 5834 (0.03%)
    0 / 5845 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 5834 (0.02%)
    0 / 5845 (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: 1%
    Non-serious adverse events
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 5834 (0.79%)
    75 / 5845 (1.28%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    46 / 5834 (0.79%)
    75 / 5845 (1.28%)
         occurrences all number
    47
    75

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 May 2012
    Removed the inclusion of adolescent subjects (12≤ ages < 18) for France.
    06 Nov 2013
    Removed Table 1
    06 Feb 2014
    Updated GSK Case Management contact information.
    07 May 2014
    Updated Sponsor’s medical monitor contact information and minor typographical corrections.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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