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    Clinical Trial Results:
    A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 2

    Summary
    EudraCT number
    		 2013-002239-44
    Trial protocol
    		 DE   CZ  
    Global end of trial date
    21 Apr 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    200110
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02119286
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy and safety of the addition of UMEC 125 mcg to FF/VI 100/25 mcg once-daily and the addition of UMEC 62.5 mcg to FF/VI 100/25 mcg once-daily, compared with placebo plus FF/VI 100/25 once-daily over 12 weeks in subjects with COPD.
    Protection of trial subjects
    Spirometry procedures may cause difficulty breathing, changes in pulse rate/ blood pressure, coughing, wheezing, chest tightness, or fainting. Subjects (sub.) will be monitored during the procedure for these effects, and spirometry will be discontinued if they occur. Skin irritation is rare but could occur during ECG from the ECG electrodes. It may be necessary to have patches of hair on the chest shaved to properly attach electrodes. Sub. will be monitored during the procedure for these effects and should call their study doctor if effects do not resolve. Side effects of albuterol/salbutamol include shakiness, headache, sleeplessness, high blood pressure, heart beating fast/irregular beats, cough, wheezing, shortness of breath, increased fluid in the mouth, nausea, upset stomach, tiredness, anxiety/nervousness, or low blood potassium. Sub. should call their study doctor if they experience any of these symptoms. Sub. with poorly controlled COPD or who experience an exacerbation of COPD during the run-in period will not be randomized. ICS/LABA combination therapy is associated with an increased risk of pneumonia but no other significant side effects in COPD. Sub. with a lower respiratory tract infection that required antibiotics within 6 weeks prior to Visit 1 are excluded from the study in order to ensure safety. LABAs may increase the risk of asthma-related death. Sub. with a current diagnosis of asthma will be excluded from study participation. Cardiovascular (CV) effects such as cardiac arrhythmias, e.g., supraventricular tachycardia and extrasystoles, are also class effects associated with LABAs and LABA-containing therapy. Exclusion criteria have been set for sub. with uncontrolled or severe CV disease according to the PI’s opinion where the potential risk may outweigh the benefit. The Investigator should also determine the clinical significance of abnormal ECG findings at screening and exclude sub. who would be at undue risk by participating in the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Oct 2013
    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
    Czech Republic: 97
    Country: Number of subjects enrolled
    Germany: 331
    Country: Number of subjects enrolled
    United States: 221
    Country: Number of subjects enrolled
    Korea, Republic of: 81
    Worldwide total number of subjects
    730
    EEA total number of subjects
    428
    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)
    0
    Adults (18-64 years)
    405
    From 65 to 84 years
    321
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants ≥ 40 years of age with history of chronic obstructive pulmonary disease (COPD) and a smoking history of ≥ 10 pack-years were enrolled in the study. Participants completed a 4-week run-in period, in which they received fluticasone furoate 100 micrograms(µg)/vilanterol 25 µg, followed by a 12-week treatment period and a 1-week follow-up.

    Pre-assignment
    Screening details
    		 A total of 620 participants were randomized to study treatment. However, only 619 of these 620 participants compromised the Intent-to-Treat Population, defined as all participants randomized to treatment who received ≥ 1 dose of randomized study medication in the treatment period.

    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
    		 Fluticasone furoate/vilanterol 100/25 µg + placebo
    Arm description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
    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
    Matching placebo once daily

    Investigational medicinal product name
    Fluticasone furoate/vilanterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate/vilanterol 100/25 µg once daily

    Arm title
    		 Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg
    Arm description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide (UMEC) 62.5 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Umeclidinium bromide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Umeclidinium bromide 62.5 µg once daily

    Investigational medicinal product name
    Fluticasone furoate/vilanterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate/vilanterol 100/25 µg once daily

    Arm title
    		 Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Arm description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Umeclidinium bromide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Umeclidinium bromide 125 µg once daily

    Investigational medicinal product name
    Fluticasone furoate/vilanterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate/vilanterol 100/25 µg once daily

    Number of subjects in period 1 [1]
    		Fluticasone furoate/vilanterol 100/25 µg + placebo Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Started
    206
    206
    207
    Completed
    180
    195
    200
    Not completed
    26
    11
    7
         Adverse event, serious fatal
    4
    4
    -
         Consent withdrawn by subject
    4
    1
    -
         Adverse event, non-fatal
    5
    3
    2
         Lost to follow-up
    2
    -
    1
         Lack of efficacy
    11
    3
    4
    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: The baseline period includes only those enrolled participants who were randomized to treatment and received >=1 dose of randomized study medication in the Treatment Period (n=619).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + placebo
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide (UMEC) 62.5 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group values
    		 Fluticasone furoate/vilanterol 100/25 µg + placebo Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg Total
    Number of subjects
    		 206 206 207 619
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.6 ( 9 ) 62.6 ( 8.12 ) 63.4 ( 7.49 ) -
    Gender categorical
    Units: Subjects
        Female
    		 81 71 76 228
        Male
    		 125 135 131 391
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 6 6 6 18
        Asian - East Asian Heritage
    		 19 25 25 69
        White - White/Caucasian/European
    		 180 174 176 530
        Mixed Race
    		 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + placebo
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide (UMEC) 62.5 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Primary: Change from Baseline in trough forced expiratory volume in one second (FEV1) at Day 85

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    End point title
    		 Change from Baseline in trough forced expiratory volume in one second (FEV1) at Day 85
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value. The number of participants presented represent those with data available at the time point being presented; however, all participants in the Intent-to-Treat (ITT) Population without missing covariate information and with at least one post baseline measurement are included in the analysis.
    End point type
    Primary
    End point timeframe
    Day 85
    End point values
    		 Fluticasone furoate/vilanterol 100/25 µg + placebo Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Number of subjects analysed
    179 [1]
    195 [2]
    199 [3]
    Units: Liters
        least squares mean (standard error)
    -0.03 ( 0.011 )
    0.092 ( 0.0107 )
    0.081 ( 0.0106 )
    Notes
    [1] - Note: 205 subjects had analyzable data for one or more timepoints.
    [2] - Note: 205 subjects had analyzable data for one or more timepoints.
    [3] - Note: 206 subjects had analyzable data for one or more timepoints.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg v Fluticasone furoate/vilanterol 100/25 µg + placebo
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Mixed Model Repeated Measure
    Parameter type
    		 Least squared mean difference
    Point estimate
    0.122
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.091
         upper limit
    		 0.152
    Notes
    [4] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Fluticasone furoate/vilanterol 100/25 µg + placebo v Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.001 [6]
    Method
    		 Mixed Model Repeated Measure
    Parameter type
    		 Least squared mean difference
    Point estimate
    0.111
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.081
         upper limit
    		 0.141
    Notes
    [5] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
    [6] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)

    Secondary: Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

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    End point title
    		 Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value. All participants in the ITT Population without missing covariate information and with at least one post baseline measurement are included in the analysis.
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    		 Fluticasone furoate/vilanterol 100/25 µg + placebo Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Number of subjects analysed
    180 [7]
    195 [8]
    199 [9]
    Units: Liters
        least squares mean (standard error)
    0.017 ( 0.0118 )
    0.164 ( 0.0115 )
    0.152 ( 0.0114 )
    Notes
    [7] - Note: 205 subjects had analyzable data for one or more timepoints.
    [8] - Note: 206 subjects had analyzable data for one or more timepoints..
    [9] - Note: 206 subjects had analyzable data for one or more timepoints.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone furoate/vilanterol 100/25 µg + placebo v Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 < 0.001 [11]
    Method
    		 Mixed Model Repeated Measure
    Parameter type
    		 Least squared mean difference
    Point estimate
    0.147
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.114
         upper limit
    		 0.179
    Notes
    [10] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
    [11] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Fluticasone furoate/vilanterol 100/25 µg + placebo v Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 < 0.001 [13]
    Method
    		 Mixed Model Repeated Measure
    Parameter type
    		 Least squared mean difference
    Point estimate
    0.135
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.103
         upper limit
    		 0.167
    Notes
    [12] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
    [13] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)

    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 start of study medication until follow-up visit (up to 14 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 randomized to treatment who received at least one dose of randomized study medication in the treatment period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + placebo
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide (UMEC) 62.5 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Reporting group title
    Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Reporting group description
    		 Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

    Serious adverse events
    		 Fluticasone furoate/vilanterol 100/25 µg + placebo Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 206 (5.34%)
    8 / 206 (3.88%)
    3 / 207 (1.45%)
         number of deaths (all causes)
    4
    4
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
    0 / 207 (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
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
    0 / 207 (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
    Humerus fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    3 / 206 (1.46%)
    2 / 206 (0.97%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 206 (0.00%)
    0 / 206 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 206 (1.46%)
    3 / 206 (1.46%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal aneurysm
         subjects affected / exposed
    0 / 206 (0.00%)
    0 / 206 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
    0 / 207 (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
    Pneumonia
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 206 (0.97%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    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
    		 Fluticasone furoate/vilanterol 100/25 µg + placebo Fluticasone furoate/vilanterol 100/25 µg + UMEC 62.5 µg Fluticasone furoate/vilanterol 100/25 µg + UMEC 125 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 206 (13.59%)
    23 / 206 (11.17%)
    22 / 207 (10.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 206 (2.43%)
    8 / 206 (3.88%)
    4 / 207 (1.93%)
         occurrences all number
    6
    10
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 206 (1.94%)
    8 / 206 (3.88%)
    2 / 207 (0.97%)
         occurrences all number
    7
    8
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    22 / 206 (10.68%)
    11 / 206 (5.34%)
    19 / 207 (9.18%)
         occurrences all number
    23
    12
    19

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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