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    Clinical Trial Results:
    HZA106855: A dose-ranging study of fluticasone furoate (FF) inhalation powder in children aged 5-11 years with asthma.

    Summary
    EudraCT number
    		 2011-003338-15
    Trial protocol
    		 SE   DE   Outside EU/EEA   PL   LV  
    Global end of trial date
    24 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    28 Mar 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HZA106855
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01563029
    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 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000431-PIP01-08
    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
    14 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the dose response, efficacy and safety of three doses of fluticasone furoate (FF) inhalation powder administered once daily in the evening to children aged 5-11 years with persistent uncontrolled asthma over a 12 week treatment period.
    Protection of trial subjects
    The following steps were taken to protect trial participants: 1). Only participants meeting all of the inclusion criteria and none of the exclusion criteria were randomized to investigational medication. 2). All participants enrolled into the study were provided rescue medication for use as necessary. 3). Subject lung function, as measured by morning (AM) and evening (PM) peak expiratory flow (PEF), was monitored for stability through the use of a daily electronic diary. 4). The investigator or treating physician could have unblinded a participant’s treatment assignment in the case of an emergency, when knowledge of the study treatment was essential for the appropriate clinical management or welfare of the participant.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2012
    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
    Poland: 163
    Country: Number of subjects enrolled
    Bulgaria: 43
    Country: Number of subjects enrolled
    Germany: 35
    Country: Number of subjects enrolled
    Latvia: 34
    Country: Number of subjects enrolled
    Russian Federation: 129
    Country: Number of subjects enrolled
    United States: 359
    Country: Number of subjects enrolled
    Puerto Rico: 11
    Country: Number of subjects enrolled
    Japan: 135
    Country: Number of subjects enrolled
    Ukraine: 92
    Country: Number of subjects enrolled
    Peru: 163
    Country: Number of subjects enrolled
    Mexico: 323
    Country: Number of subjects enrolled
    Georgia: 24
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Philippines: 8
    Country: Number of subjects enrolled
    Sweden: 18
    Worldwide total number of subjects
    1540
    EEA total number of subjects
    293
    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)
    1540
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 1540 participants were screened, 596 participants were randomized, and 593 participants comprise the Intent to Treat Population which include all participants who received at least one dose of study treatment. Participants were stratified at randomization according to their prior inhaled corticosteroid (ICS) use.

    Pre-assignment
    Screening details
    		 Participants who met the eligibility criteria at screening (Visit 1) entered a 4-week Run-in Period during which they continued their existing medications. Participants who met the randomization criteria (remained uncontrolled despite baseline therapy) at Visit 3 were randomized to 1 of 5 treatment arms for 12 weeks followed by a 1-week follow-up.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Arm title
    		 FF 25 µg OD
    Arm description
    		 Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    25 µg (micrograms) once daily via a dry powder inhaler

    Arm title
    		 FF 50 µg OD
    Arm description
    		 Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50 µg once daily via a dry powder inhaler

    Arm title
    		 FF 100 µg OD
    Arm description
    		 Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    100 µg once daily via a dry powder inhaler

    Arm title
    		 FP 100 µg BID
    Arm description
    		 Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    100 µg twice daily via a dry powder inhaler

    Number of subjects in period 1 [1]
    		Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Started
    119
    118
    120
    118
    118
    Completed
    66
    94
    87
    85
    89
    Not completed
    53
    24
    33
    33
    29
         Consent withdrawn by subject
    4
    1
    3
    4
    3
         Physician decision
    3
    5
    2
    4
    2
         Adverse event, non-fatal
    1
    -
    1
    2
    1
         Protocol defined stopping criteria
    1
    -
    -
    -
    -
         Lost to follow-up
    1
    -
    1
    1
    1
         Lack of efficacy
    42
    16
    23
    21
    19
         Protocol deviation
    1
    2
    3
    1
    3
    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: 1540 participants were enrolled and screened, 596 participants were randomized, and 593 participants comprise the Intent to Treat which include all participants who received at least one dose of study treatment and is outlined in the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 25 µg OD
    Reporting group description
    		 Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 50 µg OD
    Reporting group description
    		 Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 100 µg OD
    Reporting group description
    		 Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FP 100 µg BID
    Reporting group description
    		 Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID Total
    Number of subjects
    		 119 118 120 118 118 593
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8 ( 1.91 ) 7.9 ( 2.08 ) 8.4 ( 1.62 ) 7.8 ( 2.04 ) 7.9 ( 1.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 49 41 46 48 39 223
        Male
    		 70 77 74 70 79 370
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 4 4 7 8 7 30
        American Indian or Alaskan Native
    		 24 17 16 17 21 95
        Asian -Central/South Asian Heritage
    		 1 0 1 0 0 2
        Asian - Japanese Heritage
    		 7 7 5 2 7 28
        White - Arabic/North African Heritage
    		 1 2 0 1 0 4
        White - White/Caucasian/European Heritage
    		 47 55 51 51 43 247
        Mixed Race
    		 35 33 40 39 40 187

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 25 µg OD
    Reporting group description
    		 Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 50 µg OD
    Reporting group description
    		 Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 100 µg OD
    Reporting group description
    		 Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FP 100 µg BID
    Reporting group description
    		 Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Subject analysis set title
    Intent to Treat Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    participants randomized to treatment who received at least 1 dose of study medication.

    Subject analysis set title
    Average of FF 50 µg OD and FF 100 µg OD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Primary: Change from Baseline in daily pre-dose morning (AM) peak expiratory flow (PEF) from participant electronic daily diary averaged over the 12-week Treatment Period

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    End point title
    		 Change from Baseline in daily pre-dose morning (AM) peak expiratory flow (PEF) from participant electronic daily diary averaged over the 12-week Treatment Period
    End point description
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.
    End point type
    Primary
    End point timeframe
    Baseline, Week 1 up to Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID Average of FF 50 µg OD and FF 100 µg OD
    Number of subjects analysed
    119 [1]
    117 [2]
    118 [3]
    118 [4]
    117 [5]
    236 [6]
    Units: Liters per minute (L/min)
        least squares mean (standard error)
    3.3 ( 2.63 )
    21.9 ( 2.66 )
    22.8 ( 2.65 )
    15.8 ( 2.64 )
    17.3 ( 2.64 )
    19.3 ( 1.86 )
    Notes
    [1] - ITT Population participants randomized to treatment who received at least 1 dose of study medication
    [2] - ITT Population participants randomized to treatment who received at least 1 dose of study medication
    [3] - ITT Population participants randomized to treatment who received at least 1 dose of study medication
    [4] - ITT Population participants randomized to treatment who received at least 1 dose of study medication
    [5] - ITT Population participants randomized to treatment who received at least 1 dose of study medication
    [6] - ITT Population participants randomized to treatment who received at least 1 dose of study medication
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Gate-keeper analysis
    Comparison groups
    Placebo v Average of FF 50 µg OD and FF 100 µg OD
    Number of subjects included in analysis
    355
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.6
         upper limit
    		 22.4
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.1
         upper limit
    		 19.8
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 26.9
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebo comparison.
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 26
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.7
         upper limit
    		 21.4

    Secondary: Change from Baseline in evening clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at the end of the 12-week Treatment Period in children who could perform the maneuver

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    End point title
    		 Change from Baseline in evening clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at the end of the 12-week Treatment Period in children who could perform the maneuver
    End point description
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. Only those participants available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    102 [7]
    96 [8]
    112 [9]
    96 [10]
    102 [11]
    Units: Liters
        least squares mean (standard error)
    0.128 ( 0.0264 )
    0.254 ( 0.0272 )
    0.15 ( 0.0252 )
    0.162 ( 0.0272 )
    0.192 ( 0.0262 )
    Notes
    [7] - ITT Population, only participants available at the specified time points were analyzed.
    [8] - ITT Population, only participants available at the specified time points were analyzed.
    [9] - ITT Population, only participants available at the specified time points were analyzed.
    [10] - ITT Population, only participants available at the specified time points were analyzed.
    [11] - ITT Population, only participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.126
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.051
         upper limit
    		 0.201
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.551
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.022
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.094
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.379
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.033
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.041
         upper limit
    		 0.108
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.089
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.064
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.137

    Secondary: Change from Baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period

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    End point title
    		 Change from Baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period
    End point description
    The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 up to Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    119 [12]
    117 [13]
    118 [14]
    118 [15]
    117 [16]
    Units: Percentage of rescue-free 24-hr periods
        least squares mean (standard error)
    16.5 ( 3.01 )
    24.9 ( 3.03 )
    26.3 ( 3.03 )
    28.7 ( 3.02 )
    22.7 ( 3.01 )
    Notes
    [12] - ITT Population, only participants available at the specified time points were analyzed.
    [13] - ITT Population, only participants available at the specified time points were analyzed.
    [14] - ITT Population, only participants available at the specified time points were analyzed.
    [15] - ITT Population, only participants available at the specified time points were analyzed.
    [16] - ITT Population, only participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 16.9
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.023
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 18.2
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 20.5
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.143
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 14.6

    Secondary: Change from Baseline in daily evening (PM) PEF averaged over the 12-week Treatment Period

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    End point title
    		 Change from Baseline in daily evening (PM) PEF averaged over the 12-week Treatment Period
    End point description
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 up to Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    119 [17]
    117 [18]
    119 [19]
    118 [20]
    117 [21]
    Units: liters per minute (L/min)
        least squares mean (standard error)
    5.1 ( 2.76 )
    16.3 ( 2.81 )
    18.5 ( 2.77 )
    13.5 ( 2.78 )
    13.1 ( 2.77 )
    Notes
    [17] - ITT Population, only participants available at the specified time points were analyzed.
    [18] - ITT Population, only participants available at the specified time points were analyzed.
    [19] - ITT Population, only participants available at the specified time points were analyzed.
    [20] - ITT Population, only participants available at the specified time points were analyzed.
    [21] - ITT Population, only participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.4
         upper limit
    		 19
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.7
         upper limit
    		 21.1
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 16.1
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.042
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 15.7

    Secondary: Change from Baseline in PM PEF over the last 7 days of the Treatment Period (Week 12)

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    End point title
    		 Change from Baseline in PM PEF over the last 7 days of the Treatment Period (Week 12)
    End point description
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    119 [22]
    117 [23]
    118 [24]
    118 [25]
    117 [26]
    Units: L/min
        least squares mean (standard error)
    5 ( 3.75 )
    16.2 ( 3.8 )
    18.2 ( 3.77 )
    11 ( 3.76 )
    11.3 ( 3.75 )
    Notes
    [22] - ITT Population, only participants available at the specified time points were analyzed.
    [23] - ITT Population, only participants available at the specified time points were analyzed.
    [24] - ITT Population, only participants available at the specified time points were analyzed.
    [25] - ITT Population, only participants available at the specified time points were analyzed.
    [26] - ITT Population, only participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.037
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 21.7
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 23.6
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.266
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 16.3
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.242
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 16.6

    Secondary: Change from Baseline in AM PEF over the last 7 days of the Treatment Period (Week 12)

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    End point title
    		 Change from Baseline in AM PEF over the last 7 days of the Treatment Period (Week 12)
    End point description
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    119 [27]
    117 [28]
    118 [29]
    118 [30]
    117 [31]
    Units: L/min
        least squares mean (standard error)
    2.7 ( 3.81 )
    23.3 ( 3.85 )
    20.6 ( 3.83 )
    14.2 ( 3.82 )
    19.3 ( 3.82 )
    Notes
    [27] - ITT Population, only participants available at the specified time points were analyzed.
    [28] - ITT Population, only participants available at the specified time points were analyzed.
    [29] - ITT Population, only participants available at the specified time points were analyzed.
    [30] - ITT Population, only participants available at the specified time points were analyzed.
    [31] - ITT Population, only participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10
         upper limit
    		 31.3
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.2
         upper limit
    		 28.6
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 22.1
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 27.3

    Secondary: Change from Baseline in the percentage of symptom-free 24-hour periods during the 12-week Treatment Period

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    End point title
    		 Change from Baseline in the percentage of symptom-free 24-hour periods during the 12-week Treatment Period
    End point description
    Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 up to Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    119 [32]
    117 [33]
    119 [34]
    118 [35]
    117 [36]
    Units: Percentage of symptom-free 24-hr periods
        least squares mean (standard error)
    19 ( 2.9 )
    21 ( 2.92 )
    24.7 ( 2.9 )
    22.9 ( 2.91 )
    22 ( 2.91 )
    Notes
    [32] - ITT Population, only participants available at the specified time points were analyzed.
    [33] - ITT Population, only participants available at the specified time points were analyzed.
    [34] - ITT Population, only participants available at the specified time points were analyzed.
    [35] - ITT Population, only participants available at the specified time points were analyzed.
    [36] - ITT Population, only participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.619
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 10.2
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.161
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 13.9
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.34
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 12
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.459
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 11.1

    Secondary: Number of withdrawals due to lack of efficacy throughout the 12-week Treatment Period

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    End point title
    		 Number of withdrawals due to lack of efficacy throughout the 12-week Treatment Period
    End point description
    The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Number of subjects analysed
    119 [37]
    118 [38]
    120 [39]
    118 [40]
    118 [41]
    Units: Participants
        number (not applicable)
    42
    16
    23
    21
    19
    Notes
    [37] - ITT Population
    [38] - ITT Population
    [39] - ITT Population
    [40] - ITT Population
    [41] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 25 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 25 µg OD
    Reporting group description
    		 Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 50 µg OD
    Reporting group description
    		 Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FF 100 µg OD
    Reporting group description
    		 Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Reporting group title
    FP 100 µg BID
    Reporting group description
    		 Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.

    Serious adverse events
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 118 (0.00%)
    1 / 120 (0.83%)
    1 / 118 (0.85%)
    0 / 118 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 118 (0.00%)
    1 / 120 (0.83%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Hepatitis A
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 118 (0.00%)
    0 / 120 (0.00%)
    1 / 118 (0.85%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    		 Placebo FF 25 µg OD FF 50 µg OD FF 100 µg OD FP 100 µg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 119 (16.81%)
    27 / 118 (22.88%)
    20 / 120 (16.67%)
    29 / 118 (24.58%)
    24 / 118 (20.34%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 118 (2.54%)
    0 / 120 (0.00%)
    0 / 118 (0.00%)
    4 / 118 (3.39%)
         occurrences all number
    0
    3
    0
    0
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 119 (1.68%)
    2 / 118 (1.69%)
    2 / 120 (1.67%)
    7 / 118 (5.93%)
    4 / 118 (3.39%)
         occurrences all number
    2
    2
    2
    10
    10
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 119 (0.00%)
    4 / 118 (3.39%)
    1 / 120 (0.83%)
    2 / 118 (1.69%)
    1 / 118 (0.85%)
         occurrences all number
    0
    4
    1
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 119 (5.04%)
    7 / 118 (5.93%)
    1 / 120 (0.83%)
    10 / 118 (8.47%)
    5 / 118 (4.24%)
         occurrences all number
    8
    9
    1
    12
    5
    Rhinorrhoea
         subjects affected / exposed
    2 / 119 (1.68%)
    6 / 118 (5.08%)
    1 / 120 (0.83%)
    6 / 118 (5.08%)
    5 / 118 (4.24%)
         occurrences all number
    2
    9
    1
    8
    5
    Oropharyngeal pain
         subjects affected / exposed
    1 / 119 (0.84%)
    6 / 118 (5.08%)
    2 / 120 (1.67%)
    2 / 118 (1.69%)
    4 / 118 (3.39%)
         occurrences all number
    1
    8
    2
    2
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 119 (3.36%)
    9 / 118 (7.63%)
    4 / 120 (3.33%)
    3 / 118 (2.54%)
    4 / 118 (3.39%)
         occurrences all number
    5
    12
    5
    3
    4
    Pharyngitis
         subjects affected / exposed
    4 / 119 (3.36%)
    2 / 118 (1.69%)
    7 / 120 (5.83%)
    5 / 118 (4.24%)
    1 / 118 (0.85%)
         occurrences all number
    5
    2
    8
    5
    2
    Bronchitis
         subjects affected / exposed
    1 / 119 (0.84%)
    2 / 118 (1.69%)
    4 / 120 (3.33%)
    2 / 118 (1.69%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    4
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 119 (2.52%)
    1 / 118 (0.85%)
    0 / 120 (0.00%)
    4 / 118 (3.39%)
    3 / 118 (2.54%)
         occurrences all number
    3
    1
    0
    4
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Feb 2012
    The purpose of this amendment is to specify that Japan will not conduct the Paediatric Asthma Quality of Life (PAQLQ) measure on children enrolled in this protocol.
    05 Jul 2012
    The purpose of this amendment is to make changes to the ICS doses allowed prior to Visit 1. Additional edits were made to the statistical sections to the effect that the primary analysis will be the comparison of each dose regimen of fluticasone furoate with placebo.
    14 Dec 2012
    The purpose of this amendment is to revise the dose for Clenil and Qvar used prior to Visit 1 and to allow for the-re screening of subjects who failed Visit 1 criteria.
    19 Sep 2013
    The purpose of this amendment is to implement a change to the time of the primary endpoint, daily PEF, from evening to morning assessments. Additional edits were made to the time point for the primary endpoint (from an endpoint assessment to the average over the treatment period) and to the statistical analysis of the primary endpoint including multiplicity adjustment methods.

    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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