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    Clinical Trial Results:
    A 6-month, open label, randomised, efficacy study to evaluate fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder delivered once daily via the Dry Powder Inhaler Ellipta™ compared with usual ICS/LABA maintenance therapy delivered by Dry Powder Inhaler in subjects with Persistent Asthma

    Summary
    EudraCT number
    		 2014-000551-81
    Trial protocol
    		 DE  
    Global end of trial date
    20 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2018
    First version publication date
    20 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    116492
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    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
    04 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2017
    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 of fluticasone furoate (FF)/vilanterol (VI) 100 mcg/ 25 mcg or FF/VI 200 mcg/25 mcg with usual fixed combinations inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) for asthma maintenance therapy at Week 12 (Visit 4).
    Protection of trial subjects
    Eligibility criteria have been incorporated into the protocol to exclude participants for whom any of the study treatments are contraindicated e.g. participants with historical or current evidence of uncontrolled or clinically significant cardiovascular disease, chronic users of systemic corticosteroids, participants with a history of life-threatening asthma, including severe and unstable asthma, and/or history of repeated severe exacerbations (3/year) and/or exacerbation in the previous 6 weeks. The protocol requires that spirometry procedures are stopped if participants experience shortness of breath, coughing, light-headedness and/or chest tightness.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2015
    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
    France: 226
    Country: Number of subjects enrolled
    Germany: 213
    Worldwide total number of subjects
    439
    EEA total number of subjects
    439
    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)
    1
    Adults (18-64 years)
    368
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 439 participants with persistent asthma were screened. The study was conducted at 63 centers in 2 countries: 43 in France and 20 in Germany from 09 July 2015 to 20 July 2017. Age value being reported for all participants is an approximate age accurate to within + or -1 year.

    Pre-assignment
    Screening details
    		 A total of 439 participants were screened for this study and 423 participants were randomized to treatment. Three of the randomized participants did not receive study treatment and were not included in the Intent-To-Treat (ITT) population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Usual ICS/LABA
    Arm description
    		 Eligible participants received fixed combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) (Fluticasone propionate [FP]/ Salmeterol [S] 250/50 micrograms [mcg] or 500/50 mcg, 1 inhalation twice daily; or Budesonide [BUD]/ Formoterol [F] 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate (FP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    FP 250 mcg or 500 mcg blended with lactose administered twice daily via DISKUS DPI.

    Investigational medicinal product name
    Salmeterol (S)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salmeterol 50 mcg blended with lactose administered twice daily via DISKUS DPI.

    Investigational medicinal product name
    Budesonide (BUD)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    BUD 200 mcg or 400 mcg blended with lactose administered twice daily via TURBUHALER DPI.

    Investigational medicinal product name
    Formoterol (F)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol 6 mcg or 12 mcg blended with lactose administered twice daily via TURBUHALER DPI.

    Arm title
    		 FF/VI
    Arm description
    		 Eligible participants received Fluticasone Furoate (FF)/ Vilanterol (VI) 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Furoate (FF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    FF 100 mcg or 200 mcg blended with lactose administered once daily via ELLIPTA dry powder inhaler (DPI).

    Investigational medicinal product name
    Vilanterol (VI)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    VI 25 mcg blended with lactose and magnesium stearate administered once daily via ELLIPTA DPI.

    Number of subjects in period 1 [1]
    		Usual ICS/LABA FF/VI
    Started
    210
    210
    Completed
    192
    194
    Not completed
    18
    16
         Physician decision
    5
    1
         Consent withdrawn by subject
    3
    3
         Protocol defined stopping criteria reach
    1
    -
         Adverse event, non-fatal
    4
    8
         Lost to follow-up
    2
    2
         Protocol deviation
    1
    2
         Lack of efficacy
    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: A total of 439 participants were screened, of which 12 participants were inclusion/exclusion criteria failures; remaining 4 were not randomized due to physician decision, withdrawal by subject and protocol deviation. There were 3 participants who were randomized but not included in the ITT Population because they did not receive study treatment. These 3 participants were withdrawn from the study due to physician decision, withdrawal by subject and protocol deviation.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Usual ICS/LABA
    Reporting group description
    		 Eligible participants received fixed combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) (Fluticasone propionate [FP]/ Salmeterol [S] 250/50 micrograms [mcg] or 500/50 mcg, 1 inhalation twice daily; or Budesonide [BUD]/ Formoterol [F] 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.

    Reporting group title
    FF/VI
    Reporting group description
    		 Eligible participants received Fluticasone Furoate (FF)/ Vilanterol (VI) 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.

    Reporting group values
    		 Usual ICS/LABA FF/VI Total
    Number of subjects
    		 210 210
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.5 ( 14.99 ) 49.3 ( 14.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 124 145 269
        Male
    		 86 65 151
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 3 4 7
        Asian - Central/South Asian Heritage
    		 0 1 1
        Asian - East Asian Heritage
    		 2 0 2
        Asian - South East Asian Heritage
    		 0 1 1
        Native Hawaiian Or Other Pacific Islander
    		 1 1 2
        White - Arabic/North African Heritage
    		 8 6 14
        White - White/Caucasian/European Heritage
    		 196 196 392
        Mixed White Race
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Usual ICS/LABA
    Reporting group description
    		 Eligible participants received fixed combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) (Fluticasone propionate [FP]/ Salmeterol [S] 250/50 micrograms [mcg] or 500/50 mcg, 1 inhalation twice daily; or Budesonide [BUD]/ Formoterol [F] 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.

    Reporting group title
    FF/VI
    Reporting group description
    		 Eligible participants received Fluticasone Furoate (FF)/ Vilanterol (VI) 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.

    Primary: Change from Baseline in asthma control test (ACT) total score at Week 12

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    End point title
    		 Change from Baseline in asthma control test (ACT) total score at Week 12
    End point description
    The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control during the past 4 weeks on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant’s asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant’s asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Usual ICS/LABA FF/VI
    Number of subjects analysed
    188 [1]
    188 [2]
    Units: Scores on a Scale
    least squares mean (standard error)
        Scores on a Scale
    2.8 ( 0.26 )
    3.6 ( 0.26 )
    Notes
    [1] - ITT Population. Only those participants available at the specified time points were analyzed.
    [2] - ITT Population. Only those participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.
    Comparison groups
    Usual ICS/LABA v FF/VI
    Number of subjects included in analysis
    376
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.033
    Method
    		 Mixed model repeated measures (MMRM)
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.5
    Notes
    [3] - Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.

    Secondary: Change from Baseline in ACT total score at Week 24

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    End point title
    		 Change from Baseline in ACT total score at Week 24
    End point description
    The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant’s asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant’s asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Usual ICS/LABA FF/VI
    Number of subjects analysed
    184 [4]
    180 [5]
    Units: Scores on a Scale
    least squares mean (standard error)
        Scores on a Scale
    3.6 ( 0.25 )
    4.0 ( 0.25 )
    Notes
    [4] - ITT Population. Only those participants available at the specified time points were analyzed.
    [5] - ITT Population. Only those participants available at the specified time points were analyzed.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.
    Comparison groups
    Usual ICS/LABA v FF/VI
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 = 0.224
    Method
    		 Mixed model repeated measures (MMRM)
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 1.1
    Notes
    [6] - Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.

    Secondary: Percentage of participants with correct use of device, defined as not making any critical or non-critical errors, at Week 12, and at Week 24 independently of the use at Week 12

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    End point title
    		 Percentage of participants with correct use of device, defined as not making any critical or non-critical errors, at Week 12, and at Week 24 independently of the use at Week 12
    End point description
    Participants were asked to read the appropriate package insert for their prescribed inhaler and then the investigator (or suitably qualified designee) demonstrated the proper use of the inhaler. The participant was then asked to self-administer their first dose of study treatment under the supervision of the investigator and any critical and non-critical errors were recorded. Individual instruments for assessing correct inhaler use were provided for each of the three devices used in this study.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Usual ICS/LABA FF/VI
    Number of subjects analysed
    210 [7]
    210 [8]
    Units: Percentage of participants
        Week 12; n= 195, 197
    93
    94
        Week 24; n= 191, 192
    96
    97
    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.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.
    Comparison groups
    FF/VI v Usual ICS/LABA
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.82 [9]
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted Odds Ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 2.62
    Notes
    [9] - Week 12
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.
    Comparison groups
    FF/VI v Usual ICS/LABA
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.566 [10]
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted Odds Ratio
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 4.6
    Notes
    [10] - Week 24

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24
    Adverse event reporting additional description
    On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    FF/VI
    Reporting group description
    		 Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.

    Reporting group title
    Usual ICS/LABA
    Reporting group description
    		 Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events above 5% threshold.
    Serious adverse events
    		 FF/VI Usual ICS/LABA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 209 (1.44%)
    4 / 210 (1.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Varicose vein ruptured
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adnexa uteri pain
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chronic sinusitis
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian abscess
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FF/VI Usual ICS/LABA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 209 (0.00%)
    0 / 210 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Aug 2015
    This protocol amendment has been created to correct mistakes in the wording of the inhaler errors questionnaires for the Ellipta®, Diskus® and Turbuhaler inhalers, which are included in Section 7.3.1 of the protocol. All references to ‘Type A errors’ and ‘overall errors’ within the protocol, have been changed to ‘critical’ and ‘non-critical’ errors, respectively, for consistency with the inhaler errors questionnaire worksheets. Storage condition instructions for Seretide® (fluticasone propionate/salmeterol) in Section 6.7 have been amended. The wording for the recommended number of spirometry efforts has been revised. New text has been included with regards to investigational product malfunction in Section 6.8. The secondary medical monitor contact information has been revised to include a new study physician. Other minor corrections and edits have been made.
    28 Apr 2016
    This amendment has been written primarily to allow the addition of a new country/countries to the study. This includes: • Removing reference to France unless specifically required • Amending text to make language more applicable to participating countries • Updating the number of sites • Defining permitted ‘usual ICS/LABA combinations’ The endpoint associated with Inhaler Correct Use has been further defined. The objective and associated endpoint of adherence with study medication has been amended to compliance with study medication. Mepolizumab (Nucala®) has been added as a prohibited medication at screening and during the study. The option to rescreen a participant following approval by the medical monitor has been added. The section describing planned dose adjustments has been updated to clarify that dose increases are permitted but switching between treatments is not permitted, in accordance with the intention of the protocol. It has been clarified that GSK will not provide treatment following the study. The T&E table has been updated to reflect that Screening, Visit 6 and Withdrawal Visit should be logged on RAMOS NG. This was previously omitted in error. The description of the Per Protocol Population has been updated to reflect terminology now used as standard at GSK. Other minor corrections and edits have been made.

    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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