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    Clinical Trial Results:
    A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects >=12 Years of Age

    Summary
    EudraCT number
    		 2010-019466-81
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Oct 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    114255
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Dec 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to FP 100mcg inhalation administered twice daily in uncontrolled asthmatic female subjects >=12 years of age over the course of 6 weeks treatment.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 2010
    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
    United States: 341
    Worldwide total number of subjects
    341
    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)
    0
    Adolescents (12-17 years)
    41
    Adults (18-64 years)
    290
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 341 participants (par.) were screened, and 162 participants were randomized. A protocol amendment necessitated withdrawal of all male participants and further enrollment of female participants only.

    Pre-assignment
    Screening details
    		 Par. meeting screening criteria, self-administered open-label fluticasone propionate 100 micrograms (µg) twice daily for 14-28 days. Eligible par. were assigned to 1 of 10 treatment sequences, receiving 4 of 5 double-blind treatments. Par. aged 12-14 years did not receive montelukast. Rescue medication (albuterol inhalation) was provided.

    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
    		 Investigator, Subject

    Arms
    Arm title
    		 All Treatments Combined
    Arm description
    		 In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    One inhalation of fluticasone propionate 100 µg BID for 6 weeks

    Investigational medicinal product name
    GSK2190915 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of GSK2190915 100 mg every morning for 6 weeks

    Investigational medicinal product name
    Fluticasone Propionate/Salmeterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    One inhalation of fluticasone propionate/salmeterol 100 µg /50 µg BID for 6 weeks

    Investigational medicinal product name
    GSK2190915 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of GSK2190915 200 mg every morning for 6 weeks

    Investigational medicinal product name
    Placebo to match GSK2190915
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets every morning for 6 weeks

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule of montelukast 10 mg every evening for 6 weeks

    Investigational medicinal product name
    Placebo to match Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule every evening for 6 weeks

    Number of subjects in period 1 [1]
    		All Treatments Combined
    Started
    162
    Completed
    93
    Not completed
    69
         Physician decision
    3
         Consent withdrawn by subject
    9
         Adverse event, non-fatal
    1
         other Sponsor Decision (Protocol Amendme
    11
         Lost to follow-up
    3
         Lack of efficacy
    36
         Protocol deviation
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 341 participants were screened and 162 participants were randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Treatments Combined
    Reporting group description
    		 In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.

    Reporting group values
    		 All Treatments Combined Total
    Number of subjects
    		 162
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ( 14.43 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 151 151
        Male
    		 11 11
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 42 42
        American Indian or Alaska Native
    		 1 1
        Asian - Central/South Asian Heritage
    		 1 1
        White - White/Caucasian/European Heritage
    		 115 115
        Mixed Race
    		 2 2
        Missing
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    All Treatments Combined
    Reporting group description
    		 In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.

    Subject analysis set title
    FP + Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.

    Subject analysis set title
    FP + GSK2190915 100 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.

    Subject analysis set title
    FP + GSK2190915 300 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.

    Subject analysis set title
    FP + Montelukast
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.

    Subject analysis set title
    FP / Salmeterol
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.

    Primary: Trough (AM pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) at the end of the 6-week treatment period

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    End point title
    		 Trough (AM pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) at the end of the 6-week treatment period
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant’s last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population (ITT) is defined as all participants who were randomized and received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    End of Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [1]
    92 [2]
    93 [3]
    94 [4]
    93 [5]
    Units: Liters (L)
        least squares mean (standard error)
    2.36 ( 0.03 )
    2.39 ( 0.03 )
    2.4 ( 0.03 )
    2.42 ( 0.03 )
    2.43 ( 0.03 )
    Notes
    [1] - ITT Population
    [2] - ITT Population
    [3] - ITT Population
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + GSK2190915 100 mg v FP + Placebo
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.268
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.026
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.07
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.08
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.042
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.09
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.017
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.056
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.1
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.074
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.12

    Secondary: Daily trough (morning pre-dose and pre-rescue bronchodilator) morning peak expiratory flow (PEF) averaged over the last 3 weeks of the 6-week treatment period

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    End point title
    		 Daily trough (morning pre-dose and pre-rescue bronchodilator) morning peak expiratory flow (PEF) averaged over the last 3 weeks of the 6-week treatment period
    End point description
    The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [6]
    92 [7]
    92 [8]
    93 [9]
    95 [10]
    Units: Liters/minute (L/min)
        least squares mean (standard error)
    349.19 ( 4.08 )
    350.14 ( 4.06 )
    354.96 ( 4.07 )
    354.17 ( 4.05 )
    361.33 ( 4.05 )
    Notes
    [6] - ITT Population
    [7] - ITT Population
    [8] - ITT Population
    [9] - ITT Population
    [10] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.751
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.946
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.91
         upper limit
    		 6.81
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.049
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.771
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 11.51
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.123
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.983
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 11.32
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.93
         upper limit
    		 18.35

    Secondary: Daily evening PEF averaged over the last 3 weeks of the 6-week treatment period

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    End point title
    		 Daily evening PEF averaged over the last 3 weeks of the 6-week treatment period
    End point description
    The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [11]
    92 [12]
    92 [13]
    93 [14]
    95 [15]
    Units: L/min
        least squares mean (standard error)
    354.06 ( 4.03 )
    355.71 ( 4.02 )
    359.16 ( 4.03 )
    358.88 ( 4.01 )
    364.35 ( 4 )
    Notes
    [11] - ITT Population
    [12] - ITT Population
    [13] - ITT Population
    [14] - ITT Population
    [15] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.563
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.651
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.97
         upper limit
    		 7.27
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.072
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 10.67
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.126
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.822
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 11.02
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.292
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.21
         upper limit
    		 16.38

    Secondary: Daily (average of morning and evening) PEF averaged over the last 3 weeks of the 6 -week treatment period between GSK2190915 and montelukast groups

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    End point title
    		 Daily (average of morning and evening) PEF averaged over the last 3 weeks of the 6 -week treatment period between GSK2190915 and montelukast groups
    End point description
    The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast
    Number of subjects analysed
    93 [16]
    92 [17]
    93 [18]
    Units: L/min
        least squares mean (standard error)
    352.37 ( 3.9 )
    356.16 ( 3.91 )
    356.52 ( 3.9 )
    Notes
    [16] - ITT Population
    [17] - ITT Population
    [18] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + GSK2190915 100 mg v FP + Montelukast
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.154
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.36
         upper limit
    		 1.06
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + GSK2190915 300 mg v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.364
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.22
         upper limit
    		 5.5

    Secondary: Daily asthma symptom score averaged over the last 3 weeks of the 6-week treatment period

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    End point title
    		 Daily asthma symptom score averaged over the last 3 weeks of the 6-week treatment period
    End point description
    Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from ‘0’ (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [19]
    90 [20]
    92 [21]
    93 [22]
    95 [23]
    Units: Score on a scale
        least squares mean (standard error)
    2.26 ( 0.12 )
    2.26 ( 0.12 )
    2.15 ( 0.12 )
    2.22 ( 0.12 )
    2.25 ( 0.12 )
    Notes
    [19] - ITT Population
    [20] - ITT Population
    [21] - ITT Population
    [22] - ITT Population
    [23] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.957
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.17
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.213
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.108
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.06
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.647
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.038
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.12
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.894
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.011
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.15

    Secondary: Daily rescue short-acting beta2-agonist (SABA) use averaged over the last 3 weeks of the 6-week treatment period

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    End point title
    		 Daily rescue short-acting beta2-agonist (SABA) use averaged over the last 3 weeks of the 6-week treatment period
    End point description
    A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [24]
    90 [25]
    92 [26]
    93 [27]
    95 [28]
    Units: Number of inhalations
        least squares mean (standard error)
    2.17 ( 0.13 )
    2.14 ( 0.13 )
    2.03 ( 0.13 )
    2.09 ( 0.13 )
    2.08 ( 0.13 )
    Notes
    [24] - ITT Population
    [25] - ITT Population
    [26] - ITT Population
    [27] - ITT Population
    [28] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.811
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.025
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.18
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.133
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 0.07
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.415
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.076
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.358
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.084
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.1

    Secondary: Percentage of symptom-free days during the last 3 weeks of the 6-week treatment period

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    End point title
    		 Percentage of symptom-free days during the last 3 weeks of the 6-week treatment period
    End point description
    Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from ‘0’ (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced (“symptom-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [29]
    92 [30]
    92 [31]
    93 [32]
    95 [33]
    Units: Percentage of days
        least squares mean (standard error)
    30.84 ( 3.04 )
    33.51 ( 3.02 )
    36.14 ( 3.03 )
    34.88 ( 3.01 )
    35.45 ( 3.02 )
    Notes
    [29] - ITT Population
    [30] - ITT Population
    [31] - ITT Population
    [32] - ITT Population
    [33] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.285
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.666
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.24
         upper limit
    		 7.57
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.035
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 10.22
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.09
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 8.7
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.047
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.602
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 9.14

    Secondary: Percentage of symptom-free nights during the last 3 weeks of the 6 week treatment period

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    End point title
    		 Percentage of symptom-free nights during the last 3 weeks of the 6 week treatment period
    End point description
    Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from ‘0’ (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced (“symptom-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [34]
    92 [35]
    92 [36]
    93 [37]
    95 [38]
    Units: Percentage of nights
        least squares mean (standard error)
    37.21 ( 2.87 )
    38.22 ( 2.85 )
    40.55 ( 2.85 )
    37.7 ( 2.84 )
    38.47 ( 2.85 )
    Notes
    [34] - ITT Population
    [35] - ITT Population
    [36] - ITT Population
    [37] - ITT Population
    [38] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.668
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.64
         upper limit
    		 5.67
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.156
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.349
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 7.98
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.822
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.496
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.83
         upper limit
    		 4.82
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.555
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 5.46

    Secondary: Percentage of rescue-free days during the last 3 weeks of the 6-week treatment period

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    End point title
    		 Percentage of rescue-free days during the last 3 weeks of the 6-week treatment period
    End point description
    Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used (“rescue-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [39]
    92 [40]
    92 [41]
    93 [42]
    95 [43]
    Units: Percentage of days
        least squares mean (standard error)
    40.44 ( 3.05 )
    42.43 ( 3.03 )
    42.59 ( 3.04 )
    42.77 ( 3.02 )
    41.96 ( 3.03 )
    Notes
    [39] - ITT Population
    [40] - ITT Population
    [41] - ITT Population
    [42] - ITT Population
    [43] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.367
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.992
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.35
         upper limit
    		 6.33
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.332
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.147
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 6.49
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.277
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.331
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 6.55
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.467
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.521
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.59
         upper limit
    		 5.63

    Secondary: Percentage of rescue-free nights during the last 3 weeks of the 6-week treatment period

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    End point title
    		 Percentage of rescue-free nights during the last 3 weeks of the 6-week treatment period
    End point description
    Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used (“rescue-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [44]
    92 [45]
    92 [46]
    93 [47]
    95 [48]
    Units: Percentage of nights
        least squares mean (standard error)
    45.12 ( 2.87 )
    45.69 ( 2.85 )
    48.79 ( 2.86 )
    45.32 ( 2.85 )
    43.98 ( 2.85 )
    Notes
    [44] - ITT Population
    [45] - ITT Population
    [46] - ITT Population
    [47] - ITT Population
    [48] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.789
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.575
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.65
         upper limit
    		 4.8
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.087
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.669
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 7.87
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.923
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.84
         upper limit
    		 4.24
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.571
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.137
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.08
         upper limit
    		 2.81

    Secondary: Percentage of nights without awakenings due to asthma during the last 3 weeks of the 6-week treatment period

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    End point title
    		 Percentage of nights without awakenings due to asthma during the last 3 weeks of the 6-week treatment period
    End point description
    Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    92 [49]
    92 [50]
    92 [51]
    93 [52]
    95 [53]
    Units: Percentage of nights
        least squares mean (standard error)
    37.21 ( 2.87 )
    38.22 ( 2.85 )
    40.55 ( 2.85 )
    37.7 ( 2.84 )
    38.47 ( 2.85 )
    Notes
    [49] - ITT Population
    [50] - ITT Population
    [51] - ITT Population
    [52] - ITT Population
    [53] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.668
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.64
         upper limit
    		 5.67
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.156
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.349
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 7.98
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.822
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.496
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.83
         upper limit
    		 4.82
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.555
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 5.46

    Secondary: Number of participants withdrawn due to lack of efficacy during the last 3 weeks of the 6-week treatment period

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    End point title
    		 Number of participants withdrawn due to lack of efficacy during the last 3 weeks of the 6-week treatment period
    End point description
    Participants were withdrawn if they met any of the following three criteria for ‘lack of efficacy’: 1) Clinic FEV1 below the FEV1 ‘Stability Limit’ value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF ‘Stability Limit’ for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher’s Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Number of subjects analysed
    104 [54]
    103 [55]
    96 [56]
    99 [57]
    104 [58]
    Units: Number of participants
    9
    5
    3
    7
    5
    Notes
    [54] - ITT Population
    [55] - ITT Population
    [56] - ITT Population
    [57] - ITT Population
    [58] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP + Placebo v FP + GSK2190915 100 mg
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.408
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    FP + Placebo v FP + GSK2190915 300 mg
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.138
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    FP + Placebo v FP + Montelukast
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.797
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    FP + Placebo v FP / Salmeterol
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.408
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
    Adverse event reporting additional description
    On-treatment AEs and SAEs are reported for the ITT Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    FP + Placebo
    Reporting group description
    		 Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.

    Reporting group title
    FP + GSK2190915 100 mg
    Reporting group description
    		 Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.

    Reporting group title
    FP + GSK2190915 300 mg
    Reporting group description
    		 Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.

    Reporting group title
    FP + Montelukast
    Reporting group description
    		 Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.

    Reporting group title
    FP / Salmeterol
    Reporting group description
    		 Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.

    Serious adverse events
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 96 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 96 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 FP + Placebo FP + GSK2190915 100 mg FP + GSK2190915 300 mg FP + Montelukast FP / Salmeterol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 104 (7.69%)
    3 / 103 (2.91%)
    4 / 96 (4.17%)
    1 / 99 (1.01%)
    1 / 104 (0.96%)
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    6 / 104 (5.77%)
    1 / 103 (0.97%)
    1 / 96 (1.04%)
    1 / 99 (1.01%)
    1 / 104 (0.96%)
         occurrences all number
    6
    1
    1
    1
    1
    Sinusitis
         subjects affected / exposed
    2 / 104 (1.92%)
    2 / 103 (1.94%)
    3 / 96 (3.13%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    2
    2
    3
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2010
    To change the Medical Monitor, To provide rationale for only including females in the study, To change Inclusion Criterion to allow only female subjects to be enrolled into the study, To amend Inclusion Criterion so that the restriction on the FEV1/FVC ratio >0.70 applied to current and former subjects only, To remove the reference to oral (for example, bambuterol) or inhaled (for example, salmeterol/formoterol) long acting beta2-agonists being stopped on the morning prior to Visit 1 as these were already prohibited 2 weeks prior to Visit 1, To remove the adjustment for gender in the analyses.

    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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