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    Clinical Trial Results:
    A randomized, double-blind, double-dummy, parallel-group, placebo controlled (on inhaled corticosteroid medication), multicenter study to evaluate the efficacy and safety of vilanterol inhalation powder (GW642444) and salmeterol, compared with placebo in the treatment of persistent asthma in adults and adolescents uncontrolled on inhaled corticosteroids.

    Summary
    EudraCT number
    		 2010-020412-11
    Trial protocol
    		 DE   Outside EU/EEA  
    Global end of trial date
    26 Aug 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    B2C112060
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01181895
    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
    04 Oct 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder 25mcg administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
    Protection of trial subjects
    none
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 110
    Country: Number of subjects enrolled
    Germany: 65
    Country: Number of subjects enrolled
    Peru: 173
    Country: Number of subjects enrolled
    Ukraine: 88
    Country: Number of subjects enrolled
    United States: 147
    Worldwide total number of subjects
    583
    EEA total number of subjects
    175
    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)
    67
    Adults (18-64 years)
    458
    From 65 to 84 years
    58
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 347 participants (par.) were randomized to treatment; all 347 were included in the Intent-to-Treat (ITT) Population. One par. was not randomized but received treatment in error. This par. was not included in the ITT Population and is thus not captured in the Participant Flow module. This par. is categorized as being enrolled in the study (n=348).

    Pre-assignment
    Screening details
    		 Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline, safety evaluations, and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. A total of 583 par. were screened, and 347 were randomized, of which 298 completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks

    Arm title
    		 Vilanteral 25 µg OD
    Arm description
    		 Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vilanterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    25 mcg Once daily

    Arm title
    		 Salmeterol 50 µg BID
    Arm description
    		 Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Salmeterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    50 mcg Twice Daily

    Number of subjects in period 1 [1]
    		Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Started
    116
    115
    116
    Completed
    99
    101
    98
    Not completed
    17
    14
    18
         Adverse event, serious fatal
    1
    -
    -
         Physician decision
    1
    2
    1
         Consent withdrawn by subject
    3
    -
    5
         Adverse event, non-fatal
    2
    1
    1
         Lost to follow-up
    -
    1
    2
         Lack of efficacy
    8
    9
    9
         Protocol deviation
    2
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 583 participants were screened and enrolled into the study, of these, 347 were randomized to receive study treatment.

    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 from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.

    Reporting group title
    Vilanteral 25 µg OD
    Reporting group description
    		 Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

    Reporting group title
    Salmeterol 50 µg BID
    Reporting group description
    		 Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

    Reporting group values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID Total
    Number of subjects
    		 116 115 116 347
    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)
    		 41.7 ( 16.64 ) 41 ( 17.81 ) 41.1 ( 16.84 ) -
    Gender categorical
    Units: Subjects
        Female
    		 59 68 77 204
        Male
    		 57 47 39 143
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 11 5 6 22
        American Indian or Alaska Native
    		 37 44 41 122
        Japanese/East Asian Heritage
    		 0 0 1 1
        White
    		 68 66 68 202

    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 from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.

    Reporting group title
    Vilanteral 25 µg OD
    Reporting group description
    		 Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

    Reporting group title
    Salmeterol 50 µg BID
    Reporting group description
    		 Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

    Primary: Change from Baseline in weighted-mean 24-hour serial forced expiratory volume in one second (FEV1) at Week 12

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    End point title
    		 Change from Baseline in weighted-mean 24-hour serial forced expiratory volume in one second (FEV1) at Week 12
    End point description
    FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment. The Intent-to-Treat (ITT) Population was used which includes all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    95 [1]
    101 [2]
    100 [3]
    Units: Liters
        least squares mean (standard error)
    0.289 ( 0.0429 )
    0.359 ( 0.0416 )
    0.283 ( 0.0419 )
    Notes
    [1] - ITT Population
    [2] - ITT Population
    [3] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.
    Comparison groups
    Placebo v Vilanteral 25 µg OD
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.244 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.048
         upper limit
    		 0.188
    Notes
    [4] - P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.
    Comparison groups
    Placebo v Salmeterol 50 µg BID
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.926 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.006
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.124
         upper limit
    		 0.113
    Notes
    [5] - P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.

    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 time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    115 [6]
    115 [7]
    114 [8]
    Units: Percentage of rescue-free 24-hr periods
        least squares mean (standard error)
    14.6 ( 2.71 )
    21.7 ( 2.68 )
    22.9 ( 2.72 )
    Notes
    [6] - ITT Population. Only those participants available at the indicated time points were assessed.
    [7] - ITT Population. Only those participants available at the indicated time points were assessed.
    [8] - ITT Population. Only those participants available at the indicated time points were assessed.
    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
    Participants who were symptom free for 24-hour periods during the12-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 (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    115 [9]
    115 [10]
    114 [11]
    Units: Percentage of symptom-free 24-hr periods
        least squares mean (standard error)
    12.7 ( 2.58 )
    19.4 ( 2.55 )
    19.5 ( 2.59 )
    Notes
    [9] - ITT Population. Only those participants available at the indicated time points were assessed.
    [10] - ITT Population. Only those participants available at the indicated time points were assessed.
    [11] - ITT Population. Only those participants available at the indicated time points were assessed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in individual serial FEV1 assessments at the end of the 12-week treatment period, including the 12-hour and 24-hour time points

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    End point title
    		 Change from Baseline in individual serial FEV1 assessments at the end of the 12-week treatment period, including the 12-hour and 24-hour time points
    End point description
    FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point. Only participants available at the specified time points were analyzed(represented by n=X,X,X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    116 [12]
    115 [13]
    116 [14]
    Units: Liters
    least squares mean (standard error)
        Predose, n=97,104,101
    0.302 ( 0.0446 )
    0.272 ( 0.043 )
    0.233 ( 0.0437 )
        5 min, n=95,100,98
    0.313 ( 0.045 )
    0.301 ( 0.0438 )
    0.214 ( 0.0443 )
        15 min, n=96, 101, 99
    0.308 ( 0.045 )
    0.324 ( 0.0439 )
    0.257 ( 0.0444 )
        30 min, n=96,101,100
    0.322 ( 0.0443 )
    0.344 ( 0.0432 )
    0.272 ( 0.0435 )
        60 min, n=96, 101, 100
    0.336 ( 0.0445 )
    0.352 ( 0.0433 )
    0.296 ( 0.0437 )
        2 hours, n=96, 100, 99
    0.313 ( 0.0455 )
    0.369 ( 0.0446 )
    0.335 ( 0.0449 )
        3 hours, n=96, 101, 100
    0.304 ( 0.0455 )
    0.374 ( 0.0444 )
    0.316 ( 0.0447 )
        4 hours, n=96, 101, 100
    0.311 ( 0.045 )
    0.359 ( 0.0438 )
    0.293 ( 0.0441 )
        5 hours, n=96, 100, 100
    0.292 ( 0.0455 )
    0.368 ( 0.0445 )
    0.279 ( 0.0447 )
        11 hours, n=94, 99, 96
    0.195 ( 0.0508 )
    0.312 ( 0.0494 )
    0.179 ( 0.0505 )
        12 hours, n=93,98,95
    0.25 ( 0.0477 )
    0.341 ( 0.0465 )
    0.217 ( 0.0473 )
        12.5 hours, n=96, 97, 98
    0.27 ( 0.0446 )
    0.337 ( 0.0444 )
    0.282 ( 0.0443 )
        13 hours, n= 96, 98, 100
    0.312 ( 0.0448 )
    0.341 ( 0.0442 )
    0.304 ( 0.044 )
        14 hours, n=95, 99, 99
    0.341 ( 0.0445 )
    0.401 ( 0.0436 )
    0.359 ( 0.0437 )
        16 hours, n=95, 98, 97
    0.364 ( 0.0464 )
    0.371 ( 0.0457 )
    0.357 ( 0.0461 )
        20 hours, n= 94, 101, 99
    0.318 ( 0.0485 )
    0.371 ( 0.0467 )
    0.296 ( 0.0473 )
        23 hours, n= 94, 101, 99
    0.31 ( 0.0456 )
    0.345 ( 0.044 )
    0.271 ( 0.0446 )
        24 hours, n= 95, 101, 100
    0.301 ( 0.0445 )
    0.33 ( 0.0432 )
    0.275 ( 0.0435 )
    Notes
    [12] - ITT Population. Only those participants available at the indicated time points were assessed.
    [13] - ITT Population. Only those participants available at the indicated time points were assessed.
    [14] - ITT Population. Only those participants available at the indicated time points were assessed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in daily trough (pre-dose and pre-rescue bronchodilator) PM (evening) Peak Expiratory Flow (PEF) averaged over the 12-week treatment period

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    End point title
    		 Change from Baseline in daily trough (pre-dose and pre-rescue bronchodilator) PM (evening) Peak Expiratory Flow (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. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    115 [15]
    115 [16]
    114 [17]
    Units: Liters per minute (L/min)
        least squares mean (standard error)
    11 ( 3.15 )
    24.9 ( 3.14 )
    18.8 ( 3.17 )
    Notes
    [15] - ITT Population. Only those participants available at the indicated time points were assessed.
    [16] - ITT Population. Only those participants available at the indicated time points were assessed.
    [17] - ITT Population. Only those participants available at the indicated time points were assessed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in daily AM (morning) PEF averaged over the 12-week treatment period

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    End point title
    		 Change from Baseline in daily AM (morning) 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. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    115 [18]
    115 [19]
    114 [20]
    Units: Liters per minute (L/min)
        least squares mean (standard error)
    14.2 ( 3.25 )
    28 ( 3.24 )
    23.6 ( 3.27 )
    Notes
    [18] - ITT Population. Only those participants available at the indicated time points were assessed.
    [19] - ITT Population. Only those participants available at the indicated time points were assessed.
    [20] - ITT Population. Only those participants available at the indicated time points were assessed.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated time to an increase of >=12% and >=200 milliliters (mL) above Baseline in FEV1 on Day 1 and Day 84 (0-2 hours)

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    End point title
    		 Number of participants with the indicated time to an increase of >=12% and >=200 milliliters (mL) above Baseline in FEV1 on Day 1 and Day 84 (0-2 hours)
    End point description
    The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.
    End point type
    Secondary
    End point timeframe
    Day 1 and Week 12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    113 [21]
    115 [22]
    116 [23]
    Units: Participants
    number (not applicable)
        Day 1, 5 min, n=113, 115, 116
    23
    33
    18
        Day 1, 15 min, n=113, 115, 116
    2
    11
    11
        Day 1, 30 min, n=113, 115, 1116
    3
    8
    13
        Day 1, 1 hr, n=113, 115, 116
    3
    7
    6
        Day 1, 2 hr, n=113, 115, 116
    5
    6
    11
        Day 1, Censored, n=113, 115, 116
    77
    50
    57
        Week 12, 5 min, n=96, 101, 100
    39
    42
    30
        Week 12, 15 min, n=96, 101, 100
    6
    2
    7
        Week 12, 30 min, n=96, 101, 100
    2
    2
    8
        Week 12, 1 hr, n=96, 101, 100
    1
    4
    5
        Week 12, 2 hr, n=96, 101, 100
    3
    7
    4
        Week 12, Censored, n=96, 101, 100
    45
    44
    46
    Notes
    [21] - ITT Population. Only those participants available at the indicated time points were assessed.
    [22] - ITT Population. Only those participants available at the indicated time points were assessed.
    [23] - ITT Population. Only those participants available at the indicated time points were assessed.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Global Assessment of Change questionnaire responses at the end of Week 4 and Week 12

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    End point title
    		 Number of participants with the indicated Global Assessment of Change questionnaire responses at the end of Week 4 and Week 12
    End point description
    At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    End point values
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Number of subjects analysed
    110 [24]
    109 [25]
    110 [26]
    Units: Participants
    number (not applicable)
        Week 4, AS: Much better, n=110, 109, 110
    25
    37
    34
        Week 4, AS: Somewhat better, n=110, 109, 110
    35
    43
    34
        Week 4, AS: A little better, n=110, 109, 110
    24
    14
    21
        Week 4, AS: The same, n=110, 109, 110
    17
    13
    16
        Week 4, AS: A little worse, n=110, 109, 110
    6
    1
    3
        Week 4, AS: Somewhat worse, n=110, 109, 110
    2
    0
    2
        Week 4, AS: Much worse, n=110, 109, 110
    1
    1
    0
        Week 4, RMU: Much less often, n=110, 109, 110
    18
    33
    28
        Week 4, RMU: Somewhat less often, n=110, 109, 110
    40
    31
    36
        Week 4, RMU: A little less often, n=110, 109, 110
    18
    23
    20
        Week 4, RMU: The same, n=110, 109, 110
    26
    18
    17
        Week 4, RMU: A little more often, n=110, 109, 110
    4
    3
    7
        Week 4, RMU: Somewhat more often, n=110, 109, 110
    2
    0
    2
        Week 4, RMU: Much more often, n=110, 109, 110
    2
    1
    0
        Week 12, AS: Much better, n=100, 105, 101
    31
    52
    35
        Week 12, AS: Somewhat better, n=100, 105, 101
    35
    31
    34
        Week 12, AS: A little better, n=100, 105, 101
    13
    9
    16
        Week 12, AS: The same, n=100, 105, 101
    12
    9
    11
        Week 12, AS: A little worse, n=100, 105, 101
    4
    2
    4
        Week 12, AS: Somewhat worse, n=100, 105, 101
    4
    1
    1
        Week 12, AS: Much worse, n=100, 105, 101
    1
    1
    0
        Week 12, RMU: Much less often, n=100, 105, 101
    25
    40
    32
        Week 12, RMU: Somewhat less often, n=100, 105, 101
    31
    32
    29
        Week 12, RMU: A little less often, n=100, 105, 101
    13
    16
    13
        Week 12, RMU: The same, n=100, 105, 101
    23
    11
    21
        Week 12, RMU: A little more often, n=100, 105, 101
    2
    5
    4
        Week 12, RMU: Somewhat more often, n=100, 105, 101
    4
    0
    2
        Week 12, RMU: Much more often, n=100, 105, 101
    2
    1
    0
    Notes
    [24] - ITT Population. Only those participants available at the indicated time points were assessed.
    [25] - ITT Population. Only those participants available at the indicated time points were assessed.
    [26] - ITT Population. Only those participants available at the indicated time points were assessed.
    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 start of study treatment until the End-of-Study visit (up to Week 14).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.

    Reporting group title
    Vilanteral 25 µg OD
    Reporting group description
    		 Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

    Reporting group title
    Salmeterol 50 µg BID
    Reporting group description
    		 Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

    Serious adverse events
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo Vilanteral 25 µg OD Salmeterol 50 µg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 116 (22.41%)
    26 / 115 (22.61%)
    21 / 116 (18.10%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 116 (4.31%)
    10 / 115 (8.70%)
    9 / 116 (7.76%)
         occurrences all number
    8
    12
    12
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 116 (0.00%)
    4 / 115 (3.48%)
    1 / 116 (0.86%)
         occurrences all number
    0
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    7 / 116 (6.03%)
    6 / 115 (5.22%)
    2 / 116 (1.72%)
         occurrences all number
    7
    6
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 115 (0.00%)
    5 / 116 (4.31%)
         occurrences all number
    0
    0
    6
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 116 (6.90%)
    2 / 115 (1.74%)
    2 / 116 (1.72%)
         occurrences all number
    9
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    12 / 116 (10.34%)
    9 / 115 (7.83%)
    7 / 116 (6.03%)
         occurrences all number
    13
    10
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2010
    The primary purpose of this amendment is to allow more time for requisite site randomization activities between the pre-dose FEV1 and the initial dosing of investigational product at Visit 2. (We increased this to 30 minutes.) Contact information for an additional medical monitor, a correction in the IND Number, and a Table of Clinical Laboratory Tests has also been incorporated.

    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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