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    Clinical Trial Results:
    HZA106827: A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents.

    Summary
    EudraCT number
    		 2010-019590-15
    Trial protocol
    		 DE   RO   Outside EU/EEA  
    Global end of trial date
    19 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2016
    First version publication date
    04 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HZA106827
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01165138
    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)
    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
    15 Dec 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the efficacy and safety of FF/GW642444 Inhalation Powder 100mcg/25mcg and FF 100mcg both administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.
    Protection of trial subjects
    The following steps were taken to protect trial subjects: 1). Only subjects meeting all of the inclusion criteria and none of the exclusion criteria were randomized to investigational medication. 2). All subjects enrolled into the study were provided rescue medication for use as necessary. 3). Subject lung function, as measured by AM and PM PEF was monitored for stability through the use of a daily electronic diary. 4) Both safety and efficacy parameters were also assessed by the investigator regularly in the clinic to minimise any potential risks to the patients. 5). The investigator or treating physician may unblind a subject’s treatment assignment in the case of an emergency, when knowledge of the study treatment is essential for the appropriate clinical management or welfare of the subject.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 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
    Poland: 167
    Country: Number of subjects enrolled
    Romania: 157
    Country: Number of subjects enrolled
    Germany: 126
    Country: Number of subjects enrolled
    United States: 363
    Country: Number of subjects enrolled
    Ukraine: 146
    Country: Number of subjects enrolled
    Japan: 151
    Worldwide total number of subjects
    1110
    EEA total number of subjects
    450
    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)
    149
    Adults (18-64 years)
    865
    From 65 to 84 years
    96
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants meeting eligibility criteria at the Screening visit completed a 4-week Run-in Period for Baseline safety evaluations and measures of asthma status. Participants were then randomized to a 12-week Treatment Period. 1110 participants were screened, 610 were randomized, and 609 received >=1 dose of study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
    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
    Once daily via Ellipta Device

    Arm title
    		 FF 100 µg OD
    Arm description
    		 Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    100 µg once daily via Ellipta Device

    Arm title
    		 FF/VI 100/25 µg OD
    Arm description
    		 Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FF/VI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    100/25 µg once daily via Ellipta Device

    Number of subjects in period 1 [1]
    		Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Started
    203
    205
    201
    Completed
    151
    185
    179
    Not completed
    52
    20
    22
         Physician decision
    6
    7
    6
         Consent withdrawn by subject
    6
    6
    3
         Adverse event, non-fatal
    1
    -
    2
         Lost to follow-up
    -
    1
    2
         Lack of efficacy
    32
    6
    7
         Protocol deviation
    7
    -
    2
    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: Only those enrolled participants who received >=1 dose of study treatment are reported to be in the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group title
    FF 100 µg OD
    Reporting group description
    		 Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group title
    FF/VI 100/25 µg OD
    Reporting group description
    		 Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD Total
    Number of subjects
    		 203 205 201 609
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 16.49 ) 40.4 ( 16.78 ) 40.7 ( 16.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 111 126 116 353
        Male
    		 92 79 85 256
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 14 16 13 43
        American Indian or Alaska Native
    		 0 1 0 1
        Asian - Japanese Heritage
    		 19 16 15 50
        Asian - South East Asian Heritage
    		 0 0 1 1
        White - Arabic/North African Heritage
    		 0 1 0 1
        White - White/Caucasian/European Heritage
    		 169 170 172 511
        Mixed Race
    		 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group title
    FF 100 µg OD
    Reporting group description
    		 Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group title
    FF/VI 100/25 µg OD
    Reporting group description
    		 Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Primary: Mean change from Baseline (BL) in clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at Week 12

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    End point title
    		 Mean change from Baseline (BL) in clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at Week 12
    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 the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the BL through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 12 value minus the BL value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. ITT, Intent-to-Treat.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    193 [1]
    203 [2]
    200 [3]
    Units: Liters
        least squares mean (standard error)
    0.196 ( 0.031 )
    0.332 ( 0.0302 )
    0.368 ( 0.0304 )
    Notes
    [1] - ITT Population. Only those participants with non-missing covariates and post-BL data were analyzed.
    [2] - ITT Population. Only those participants with non-missing covariates and post-BL data were analyzed.
    [3] - ITT Population. Only those participants with non-missing covariates and post-BL data were analyzed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    396
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.136
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.051
         upper limit
    		 0.222
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF/VI 100/25 µg OD
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.172
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.087
         upper limit
    		 0.258
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    FF 100 µg OD v FF/VI 100/25 µg OD
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.405
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.048
         upper limit
    		 0.12

    Primary: Weighted mean serial FEV1 over 0-24 hours post-dose at Week 12

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    End point title
    		 Weighted mean serial FEV1 over 0-24 hours post-dose at Week 12
    End point description
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    95 [4]
    106 [5]
    108 [6]
    Units: Liters
        least squares mean (standard error)
    2.542 ( 0.0456 )
    2.728 ( 0.0432 )
    2.843 ( 0.043 )
    Notes
    [4] - ITT Population. Data were calculated for participants for whom Week 12 serial FEV1 was performed.
    [5] - ITT Population. Data were calculated for participants for whom Week 12 serial FEV1 was performed.
    [6] - ITT Population. Data were calculated for participants for whom Week 12 serial FEV1 was performed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FF 100 µg OD
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.186
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.062
         upper limit
    		 0.31
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FF/VI 100/25 µg OD
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.302
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.178
         upper limit
    		 0.426
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    FF 100 µg OD v FF/VI 100/25 µg OD
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.116
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.005
         upper limit
    		 0.236

    Secondary: Change from Baseline in the percentage of rescue-free 24-hour (hr) 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 (hr) periods during the 12-week Treatment Period
    End point description
    The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). 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 to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. 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, age, and treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    202 [7]
    204 [8]
    201 [9]
    Units: Percentage of rescue-free 24-hr periods
        least squares mean (standard error)
    17.8 ( 2.26 )
    26.5 ( 2.25 )
    37.1 ( 2.26 )
    Notes
    [7] - ITT Population. Only those participants available at the specified time points were analyzed.
    [8] - ITT Population. Only those participants available at the specified time points were analyzed.
    [9] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the percentage of symptom-free 24-hour (hr) 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 (hr) 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 peak expiratory flow 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 value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. 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, age, and treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    202 [10]
    204 [11]
    201 [12]
    Units: Percentage of symptom-free 24-hr periods
        least squares mean (standard error)
    14.6 ( 2.15 )
    20.4 ( 2.13 )
    32.5 ( 2.14 )
    Notes
    [10] - ITT Population. Only those participants available at the specified time points were analyzed.
    [11] - ITT Population. Only those participants available at the specified time points were analyzed.
    [12] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the total Asthma Quality of Life Questionnaire (AQLQ) (+12) score at Week 12/Early Withdrawal

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    End point title
    		 Change from Baseline in the total Asthma Quality of Life Questionnaire (AQLQ) (+12) score at Week 12/Early Withdrawal
    End point description
    The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12/Early Withdrawal
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    149 [13]
    184 [14]
    180 [15]
    Units: Scores on a scale
        least squares mean (standard error)
    0.61 ( 0.061 )
    0.76 ( 0.055 )
    0.91 ( 0.055 )
    Notes
    [13] - ITT Population. Only those participants available at the specified time points were analyzed.
    [14] - ITT Population. Only those participants available at the specified time points were analyzed.
    [15] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants who withdrew due to lack of efficacy during the 12-week treatment period

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    End point title
    		 Number of participants who withdrew due to lack of efficacy during the 12-week treatment period
    End point description
    The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.
    End point type
    Secondary
    End point timeframe
    From the first dose of the study medication up to Week 12/Early Withdrawal
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    203 [16]
    205 [17]
    201 [18]
    Units: participants
    32
    6
    7
    Notes
    [16] - ITT Population
    [17] - ITT Population
    [18] - ITT Population
    No statistical analyses for this end point

    Secondary: Serial FEV1 over 0-1 hour post-dose at Randomization

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    End point title
    		 Serial FEV1 over 0-1 hour post-dose at Randomization
    End point description
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.
    End point type
    Secondary
    End point timeframe
    Randomization
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    203 [19]
    205 [20]
    201 [21]
    Units: Liters
    least squares mean (standard error)
        5 Minutes, n=117, 112, 117
    2.489 ( 0.0308 )
    2.493 ( 0.0314 )
    2.484 ( 0.0308 )
        15 Minutes, n=118, 115, 117
    2.491 ( 0.0336 )
    2.529 ( 0.0342 )
    2.566 ( 0.0336 )
        30 Minutes, n=118, 116, 118
    2.532 ( 0.0354 )
    2.552 ( 0.0359 )
    2.596 ( 0.0354 )
        1 Hour, n=119, 116, 119
    2.552 ( 0.0344 )
    2.571 ( 0.035 )
    2.674 ( 0.0344 )
    Notes
    [19] - ITT Population. Serial FEV1 was calculated for the participants for whom serial FEV1 was performed.
    [20] - ITT Population. Serial FEV1 was calculated for the participants for whom serial FEV1 was performed.
    [21] - ITT Population. Serial FEV1 was calculated for the participants for whom serial FEV1 was performed.
    No statistical analyses for this end point

    Secondary: Clinic visit 12-hour post-dose FEV1 at Week 12

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    End point title
    		 Clinic visit 12-hour post-dose FEV1 at Week 12
    End point description
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. The highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    93 [22]
    104 [23]
    108 [24]
    Units: Liters
        least squares mean (standard error)
    2.462 ( 0.0502 )
    2.674 ( 0.0475 )
    2.83 ( 0.0468 )
    Notes
    [22] - ITT Population. Data were analyzed in the participants for whom serial FEV1 at Week 12 was performed
    [23] - ITT Population. Data were analyzed in the participants for whom serial FEV1 at Week 12 was performed
    [24] - ITT Population. Data were analyzed in the participants for whom serial FEV1 at Week 12 was performed
    No statistical analyses for this end point

    Secondary: Weighted mean serial FEV1 over 0-24 hours post-dose on Day 0

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    End point title
    		 Weighted mean serial FEV1 over 0-24 hours post-dose on Day 0
    End point description
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry on Day 0. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements were recorded.
    End point type
    Secondary
    End point timeframe
    Day 0
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    119 [25]
    116 [26]
    119 [27]
    Units: Liters
        arithmetic mean (standard deviation)
    2.543 ( 0.8494 )
    2.552 ( 0.7527 )
    2.709 ( 0.8153 )
    Notes
    [25] - ITT Population. Data were calculated in the participants for whom serial FEV1 was performed.
    [26] - ITT Population. Data were calculated in the participants for whom serial FEV1 was performed.
    [27] - ITT Population. Data were calculated in the participants for whom serial FEV1 was performed.
    No statistical analyses for this end point

    Secondary: Weighted mean serial FEV1 over 0-4 hours post-dose at Day 0 and Week 12

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    End point title
    		 Weighted mean serial FEV1 over 0-4 hours post-dose at Day 0 and Week 12
    End point description
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Day 0 and Week 12 clinic visits. Weighted mean serial FEV1 over 0-4 hours was calculated using the serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements were recorded.
    End point type
    Secondary
    End point timeframe
    Day 0 and Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    120 [28]
    115 [29]
    119 [30]
    Units: Liters
    arithmetic mean (standard deviation)
        Day 0, n=120, 115, 119
    2.563 ( 0.8194 )
    2.522 ( 0.7479 )
    2.693 ( 0.7626 )
        Week 12, n=96, 105, 109
    2.636 ( 0.8519 )
    2.657 ( 0.7912 )
    2.894 ( 0.8383 )
    Notes
    [28] - ITT Population. Data were calculated in the participants for whom Week 12 serial FEV1 was performed.
    [29] - ITT Population. Data were calculated in the participants for whom Week 12 serial FEV1 was performed.
    [30] - ITT Population. Data were calculated in the participants for whom Week 12 serial FEV1 was performed.
    No statistical analyses for this end point

    Secondary: Number of participants with bronchodilator effect

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    End point title
    		 Number of participants with bronchodilator effect
    End point description
    Bronchodilator effect is defined as an increase of FEV1 (defined as the maximal amount of air that can be forcefully exhaled in one second) from Baseline of both 12% and 200 milliliters (mL) during 24 hours, which was evaluated using the serial FEV1 measurements at Baseline (Visit 3).
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    120 [31]
    116 [32]
    120 [33]
    Units: participants
    73
    77
    97
    Notes
    [31] - ITT Population. Only the subset of participants performing serial measurements were analyzed.
    [32] - ITT Population. Only the subset of participants performing serial measurements were analyzed.
    [33] - ITT Population. Only the subset of participants performing serial measurements were analyzed.
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in daily morning (AM) peak expiratory flow (PEF) averaged over the 12-week Treatment Period

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    End point title
    		 Mean change from Baseline in daily morning (AM) peak expiratory flow (PEF) averaged over the 12-week Treatment Period
    End point description
    Peak Expiratory Flow (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. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    203 [34]
    204 [35]
    201 [36]
    Units: Liters per minute
        least squares mean (standard error)
    -0.4 ( 2.42 )
    18.3 ( 2.41 )
    32.9 ( 2.42 )
    Notes
    [34] - ITT Population. Only those participants available at the specified time points were analyzed.
    [35] - ITT Population. Only those participants available at the specified time points were analyzed.
    [36] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

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

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    End point title
    		 Mean 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 (defined as the last 7 days prior to randomization of the participants) 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 analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 12
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    202 [37]
    204 [38]
    201 [39]
    Units: Liters per minute
        least squares mean (standard error)
    -1.8 ( 2.36 )
    14.1 ( 2.34 )
    26.4 ( 2.35 )
    Notes
    [37] - ITT Population. Only those participants available at the specified time points were analyzed.
    [38] - ITT Population. Only those participants available at the specified time points were analyzed.
    [39] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Asthma Control Test (ACT) score at Week 12

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    End point title
    		 Change from Baseline in the Asthma Control Test (ACT) score at Week 12
    End point description
    The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, "How much of the time did your asthma keep you from getting as much done at work, school or at home?", "How often have you had shortness of breath?", "How often did your asthma symptoms wake you up at night or earlier than usual in the morning?", "How often have you used your rescue inhaler or nebulizer medication (such as albuterol)?" and "How would you rate your asthma control"? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12/Early Withdrawal minus the total score at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12/Early Withdrawal
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    154 [40]
    189 [41]
    185 [42]
    Units: Scores on a scale
        least squares mean (standard error)
    2.5 ( 0.26 )
    3.8 ( 0.23 )
    4.4 ( 0.23 )
    Notes
    [40] - ITT Population. Only those participants available at the specified time points were analyzed.
    [41] - ITT Population. Only those participants available at the specified time points were analyzed.
    [42] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Global Assessment of Change responses at Week 4, Week 8, and Week 12/Early Withdrawal

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    End point title
    		 Number of participants with the indicated Global Assessment of Change responses at Week 4, Week 8, and Week 12/Early Withdrawal
    End point description
    At the end of Week 4, Week 8, and Week 12/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptom); much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often (to assess the changes in the frequency of rescue medication use).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, and Week 12/Early Withdrawal
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    174 [43]
    198 [44]
    191 [45]
    Units: participants
        Week 4, AS - Much better, n=174, 198, 191
    34
    47
    65
        Week 4, AS - Somewhat better, n=174, 198, 191
    45
    65
    61
        Week 4, AS - A little better, n=174, 198, 191
    42
    47
    37
        Week 4, AS - The same, n=174, 198, 191
    33
    29
    23
        Week 4, AS - A little worse, n=174, 198, 191
    6
    10
    3
        Week 4, AS - Somewhat worse, n=174, 198, 191
    8
    0
    2
        Week 4, AS - Much worse, n=174, 198, 191
    6
    0
    0
        Week 4, RMU - Much less often, n=174, 198, 191
    39
    59
    75
        Week 4, RMU - Somewhat less often, n=174, 198, 191
    40
    48
    51
        Week 4, RMU - A little less often, n=174, 198, 191
    35
    49
    32
        Week 4, RMU - The same, n=174, 198, 191
    31
    33
    28
        Week 4, RMU - A little more often, n=174, 198, 191
    13
    6
    4
        Week 4, RMU - Somewhat more often, n=174, 198, 191
    11
    3
    1
        Week 4, RMU - Much more often, n=174, 198, 191
    5
    0
    0
        Week 8, AS - Much better, n=159, 192, 184
    36
    54
    69
        Week 8, AS - Somewhat better, n=159, 192, 184
    44
    60
    63
        Week 8, AS - A little better, n=159, 192, 184
    38
    40
    22
        Week 8, AS - The same, n=159, 192, 184
    29
    33
    24
        Week 8, AS - A little worse, n=159, 192, 184
    7
    5
    3
        Week 8, AS - Somewhat worse, n=159, 192, 184
    4
    0
    2
        Week 8, AS - Much worse, n=159, 192, 184
    1
    0
    1
        Week 8, RMU - Much less often, n=159, 191, 184
    37
    65
    86
        Week 8, RMU - Somewhat less often, n=159, 191, 184
    32
    48
    43
        Week 8, RMU - A little less often, n=159, 191, 184
    37
    34
    25
        Week 8, RMU - The same, n=159, 191, 184
    36
    39
    23
        Week 8, RMU - A little more often, n=159, 191, 184
    12
    1
    5
        Week 8, RMU - Somewhat more often, n=159, 191, 184
    4
    4
    0
        Week 8, RMU - Much more often, n=159, 191, 184
    1
    0
    2
        Week 12, AS - Much better, n=152, 187, 182
    38
    66
    86
        Week 12, AS - Somewhat better, n=152, 187, 182
    37
    49
    52
        Week 12, AS - A little better, n=152, 187, 182
    29
    35
    13
        Week 12, AS - The same, n=152, 187, 182
    29
    30
    23
        Week 12, AS - A little worse, n=152, 187, 182
    9
    7
    7
        Week 12, AS - Somewhat worse, n=152, 187, 182
    6
    0
    1
        Week 12, AS - Much worse, n=152, 187, 182
    4
    0
    0
        Week 12, RMU - Much less often, n=150, 187, 182
    42
    76
    89
        Week 12, RMU - Somewhat less often,n=150, 187, 182
    32
    46
    43
        Week 12, RMU - A little less often,n=150, 187, 182
    24
    25
    21
        Week 12, RMU - The same, n=150, 187, 182
    34
    32
    23
        Week 12, RMU - A little more often,n=150, 187, 182
    12
    6
    5
        Week 12, RMU - Somewhat more often,n=150, 187, 182
    3
    1
    1
        Week 12, RMU - Much more often, n=150, 187, 182
    3
    1
    0
    Notes
    [43] - ITT Population. Only those participants available at the specified time points were analyzed.
    [44] - ITT Population. Only those participants available at the specified time points were analyzed.
    [45] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Number of the indicated unscheduled asthma-related healthcare visits during the Treatment Period

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    End point title
    		 Number of the indicated unscheduled asthma-related healthcare visits during the Treatment Period
    End point description
    All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare were recorded.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 12/Early Withdrawal
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    203 [46]
    205 [47]
    201 [48]
    Units: visits
    arithmetic mean (standard deviation)
        Number of Home Visits (Day)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Number of Home Visits (Night)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Number of Physician Office/Practice Visits
    0 ( 0.24 )
    0 ( 0.39 )
    0 ( 0.1 )
        Number of Urgent Care/Outpatient Clinic Visits
    0 ( 0.07 )
    0 ( 0.07 )
    0 ( 0 )
        Number of Emergency Room Visits
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Number of Inpatient Hospitalization Days (ICU)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Number of Inpatient Hospitalization (GW) Days
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    Notes
    [46] - ITT Population
    [47] - ITT Population
    [48] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants who used the inhaler correctly or incorrectly at Baseline, Week 2, and Week 4

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    End point title
    		 Number of participants who used the inhaler correctly or incorrectly at Baseline, Week 2, and Week 4
    End point description
    Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed.
    End point type
    Secondary
    End point timeframe
    Baseline (BL), Week 2 (W2), and Week 4 (W4)
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    203 [49]
    205 [50]
    201 [51]
    Units: participants
        BL: Used Inhaler Correctly, n=203, 205, 201
    194
    196
    188
        BL: Used Inhaler Incorrectly, n=203, 205, 201
    9
    9
    13
        W2: Used Inhaler Correctly, n=190, 203, 200
    190
    203
    200
        W2: Used Inhaler Incorrectly, n=190, 203, 200
    0
    0
    0
        W4: Used Inhaler Correctly, n=175, 199, 195
    175
    199
    195
        W4: Used Inhaler Incorrectly, n=175, 199, 195
    0
    9
    0
    Notes
    [49] - ITT Population. Only those participants available at the specified time points were analyzed.
    [50] - ITT Population. Only those participants available at the specified time points were analyzed.
    [51] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated reason for incorrect inhaler use and who required additional instruction the indicated number of times at Baseline, Week 2, and Week 4

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    End point title
    		 Number of participants with the indicated reason for incorrect inhaler use and who required additional instruction the indicated number of times at Baseline, Week 2, and Week 4
    End point description
    Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed based on 3 steps: open the device, inhale the dose, and close the device. If the participants did not perform the maneuvers correctly, the step of the inhaler use that was performed incorrectly by the participants was recorded. The entire procedure was demonstrated once again, and the number of times that the participants required additional instruction (RAI) was recorded. "99999" is used to indicate that data are not available (no participants used the inhaler incorrectly; thus, no data can be reported at the specified time point).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, and Week 4
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    9 [52]
    9 [53]
    13 [54]
    Units: participants
        BL: Opened the Device Incorrectly, n= 9, 9, 13
    8
    4
    6
        BL: Inhaled the Dose Incorrectly, n= 9, 9, 13
    1
    5
    6
        BL: Closed the Device Incorrectly, n= 9, 9, 13
    1
    0
    1
        BL: RAI once, n= 9, 9, 13
    9
    5
    8
        BL: RAI 2 Times, n= 9, 9, 13
    0
    4
    4
        BL: RAI 3 Times, n= 9, 9, 13
    0
    0
    1
        BL: RAI >3 Times, n= 9, 9, 13
    0
    0
    0
        W2: Opened the Device Incorrectly, n= 0, 0, 0
    99999
    99999
    99999
        W2: Inhaled the Dose Incorrectly, n= 0, 0, 0
    99999
    99999
    99999
        W2: Closed the Device Incorrectly, n= 0, 0, 0
    99999
    99999
    99999
        W2: RAI once, n= 0, 0, 0
    99999
    99999
    99999
        W2: RAI 2 Times, n= 0, 0, 0,
    99999
    99999
    99999
        W2: RAI 3 Times, n= 0, 0, 0
    99999
    99999
    99999
        W2: RAI >3 Times, n= 0, 0, 0
    99999
    99999
    99999
        W4: Opened the Device Incorrectly, n= 0, 0, 0
    99999
    99999
    99999
        W4: Inhaled the Dose Incorrectly, n= 0, 0, 0
    99999
    99999
    99999
        W4: Closed the Device Incorrectly, n= 0, 0, 0
    99999
    99999
    99999
        W4: RAI once, n= 0, 0, 0
    99999
    99999
    99999
        W4: RAI 2 Times, n= 0, 0, 0
    99999
    99999
    99999
        W4: RAI 3 Times, n= 0, 0, 0
    99999
    99999
    99999
        W4: RAI >3 Times, n= 0, 0, 0
    99999
    99999
    99999
    Notes
    [52] - ITT Population. Only those participants who used the inhaler incorrectly were analyzed.
    [53] - ITT Population. Only those participants who used the inhaler incorrectly were analyzed.
    [54] - ITT Population. Only those participants who used the inhaler incorrectly were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated responses to the ease of use questions regarding the inhaler at Week 4

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    End point title
    		 Number of participants with the indicated responses to the ease of use questions regarding the inhaler at Week 4
    End point description
    Participants were asked to rate the inhaler (INH) by answering the following 2 questions: How do you rate the ease of use of the inhaler?; How easily are you able to tell how many doses of medication are left in the inhaler? For each of the questions, answers were made on a five-point scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Number of subjects analysed
    176 [55]
    199 [56]
    195 [57]
    Units: participants
        Use of the INH: Very easy
    107
    126
    129
        Use of the INH: Easy
    53
    50
    54
        Use of the INH: Neutral
    13
    19
    11
        Use of the INH: Difficult
    2
    4
    1
        Use of the INH: Very difficult
    1
    0
    0
        Identifying doses left in the INH: Very easy
    126
    146
    147
        Identifying doses left in the INH: Easy
    41
    46
    39
        Identifying doses left in the INH: Neutral
    8
    6
    8
        Identifying doses left in the INH: Difficult
    1
    1
    1
        Identifying doses left in the INH: Very difficult
    0
    0
    0
    Notes
    [55] - ITT Population. Only those participants available at the specified time point were analyzed.
    [56] - ITT Population. Only those participants available at the specified time point were analyzed.
    [57] - ITT Population. Only those participants available at the specified time point were analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal.
    Adverse event reporting additional description
    SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group title
    FF 100 µg OD
    Reporting group description
    		 Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Reporting group title
    FF/VI 100/25 µg OD
    Reporting group description
    		 Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

    Serious adverse events
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 205 (0.49%)
    0 / 201 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 205 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo FF 100 µg OD FF/VI 100/25 µg OD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 203 (10.84%)
    20 / 205 (9.76%)
    29 / 201 (14.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 203 (3.94%)
    9 / 205 (4.39%)
    10 / 201 (4.98%)
         occurrences all number
    8
    18
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 203 (7.39%)
    14 / 205 (6.83%)
    20 / 201 (9.95%)
         occurrences all number
    16
    14
    24

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2010
    The original protocol, dated 22 June 2010, was amended twice. Amendment 1, dated 31 August 2010, applied to all investigational sites and was in place after the initiation of subject enrolment but prior to the unblinding of the trial data. Protocol changes specified in Amendment No. 01 were required to add a new European Union and International Medical Monitor and to extend the pre-dose FEV1 timeline, as follows: • Sites in another study had been having difficulty in meeting the timeline of 5 minutes between pre-dose FEV1 and dosing at randomisation for the serial FEV1 procedure. Therefore, in this current study, the pre-dose timeline was extended to within 30 minutes of dosing to provide the sites with more time after the pre-dose assessment to randomise the subject and retrieve the appropriate clinical supplies medication for the subjects’ first dose.

    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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