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    Clinical Trial Results:
    An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control

    Summary
    EudraCT number
    		 2017-002266-45
    Trial protocol
    		 GB   DE   NL   ES   FR   IT  
    Global end of trial date
    24 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2020
    First version publication date
    08 Feb 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    207040
    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, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    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
    08 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5)
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2018
    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
    Canada: 127
    Country: Number of subjects enrolled
    Germany: 63
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Netherlands: 34
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    United States: 112
    Worldwide total number of subjects
    437
    EEA total number of subjects
    198
    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)
    380
    From 65 to 84 years
    56
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was an open-label, randomized, multi-center, parallel group study to evaluate the effect of the connected inhaler system (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic participants (Par) with poor control.

    Pre-assignment
    Screening details
    		 A total of 528 participants were screened and 437 participants were enrolled and randomized in this study.

    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
    		 Cohort 1: Data on maintenance use supplied to Par and HCP
    Arm description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar/Breo ELLIPTA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Relvar/Breo maintenance therapy was available at doses of 100/25 microgram (mcg) and 200/25 mcg administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily

    Investigational medicinal product name
    Salbutamol MDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol rescue medication was available at dose of 100 mcg administered via metered dose inhaler (MDI), as and when required

    Arm title
    		 Cohort 2: Data on maintenance use supplied to Par
    Arm description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar/Breo ELLIPTA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Relvar/Breo maintenance therapy was available at doses of 100/25 microgram (mcg) and 200/25 mcg administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily

    Investigational medicinal product name
    Salbutamol MDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol rescue medication was available at dose of 100 mcg administered via metered dose inhaler (MDI), as and when required

    Arm title
    		 Cohort 3: Data on maintenance and rescue use to Par and HCP
    Arm description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar/Breo ELLIPTA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Relvar/Breo maintenance therapy was available at doses of 100/25 microgram (mcg) and 200/25 mcg administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily

    Investigational medicinal product name
    Salbutamol MDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol rescue medication was available at dose of 100 mcg administered via metered dose inhaler (MDI), as and when required

    Arm title
    		 Cohort 4: Data on maintenance and rescue use supplied to Par
    Arm description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar/Breo ELLIPTA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Relvar/Breo maintenance therapy was available at doses of 100/25 microgram (mcg) and 200/25 mcg administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily

    Investigational medicinal product name
    Salbutamol MDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol rescue medication was available at dose of 100 mcg administered via metered dose inhaler (MDI), as and when required

    Arm title
    		 Cohort 5: No data supplied to Par or HCP
    Arm description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar/Breo ELLIPTA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Relvar/Breo maintenance therapy was available at doses of 100/25 microgram (mcg) and 200/25 mcg administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily

    Investigational medicinal product name
    Salbutamol MDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol rescue medication was available at dose of 100 mcg administered via metered dose inhaler (MDI), as and when required

    Number of subjects in period 1
    		Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Started
    87
    88
    88
    88
    86
    Completed
    82
    81
    77
    78
    81
    Not completed
    5
    7
    11
    10
    5
         Consent withdrawn by subject
    3
    3
    5
    2
    1
         Physician decision
    -
    1
    -
    1
    1
         Adverse event, non-fatal
    1
    1
    1
    2
    -
         Lost to follow-up
    -
    2
    4
    3
    1
         Protocol deviation
    1
    -
    1
    -
    1
         Lack of efficacy
    -
    -
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Data on maintenance use supplied to Par and HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.

    Reporting group title
    Cohort 2: Data on maintenance use supplied to Par
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.

    Reporting group title
    Cohort 3: Data on maintenance and rescue use to Par and HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.

    Reporting group title
    Cohort 4: Data on maintenance and rescue use supplied to Par
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.

    Reporting group title
    Cohort 5: No data supplied to Par or HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.

    Reporting group values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP Total
    Number of subjects
    		 87 88 88 88 86 437
    Age categorical
    Units: Subjects
        Total Participants
    		 87 88 88 88 86 437
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.7 ± 15.79 47.0 ± 14.70 47.8 ± 15.28 47.8 ± 13.23 47.2 ± 15.91 -
    Sex: Female, Male
    Units: Participants
        Female
    		 64 54 59 60 47 284
        Male
    		 23 34 29 28 39 153
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian (AI) or Alaska native (AN)
    		 1 0 0 0 2 3
        Asian-Central/South Asian Heritage
    		 1 3 1 2 1 8
        Asian-East Asian Heritage
    		 1 0 0 0 1 2
        Asian-South East (SE) Asian Heritage (AH)
    		 2 2 3 2 3 12
        Black or African American
    		 10 3 8 9 4 34
        Native Hawaiian or other Pacific Islander
    		 0 1 0 0 0 1
        White-Arabic/North African heritage
    		 0 0 0 1 1 2
        White-White/Caucasian/European Heritage (EH)
    		 72 76 76 74 73 371
        AI or AN and Black or African American
    		 0 2 0 0 0 2
        AI or AN and White- White/Caucasian/EH
    		 0 1 0 0 0 1
        Asian-SE AH and White- White/Caucasian/EH
    		 0 0 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Data on maintenance use supplied to Par and HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.

    Reporting group title
    Cohort 2: Data on maintenance use supplied to Par
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.

    Reporting group title
    Cohort 3: Data on maintenance and rescue use to Par and HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.

    Reporting group title
    Cohort 4: Data on maintenance and rescue use supplied to Par
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.

    Reporting group title
    Cohort 5: No data supplied to Par or HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.

    Primary: Percentage of ELLIPTA doses taken (daily adherence) between Month 4 and Month 6 as determined by the maintenance sensor for arms; ("cohort 1: data on maintenance use supplied to participant and HCP" and"Cohort 5: no data supplied to participant or HCP")

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    End point title
    		 Percentage of ELLIPTA doses taken (daily adherence) between Month 4 and Month 6 as determined by the maintenance sensor for arms; ("cohort 1: data on maintenance use supplied to participant and HCP" and"Cohort 5: no data supplied to participant or HCP") [1]
    End point description
    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
    End point type
    Primary
    End point timeframe
    Month 4 to Month 6
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    83 [2]
    85 [3]
    Units: Percentage of ELLIPTA doses
        least squares mean (standard error)
    80.9 ± 3.19
    69.0 ± 3.19
    Notes
    [2] - ITT Population
    [3] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.2
         upper limit
    		 18.8
    Notes
    [4] - p-value was calculated using ANCOVA.

    Secondary: Percentage of ELLIPTA doses taken (daily adherence) between Month 4 and Month 6 as determined by the maintenance sensor

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    End point title
    		 Percentage of ELLIPTA doses taken (daily adherence) between Month 4 and Month 6 as determined by the maintenance sensor [5]
    End point description
    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Month 4 to Month 6
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    84 [6]
    84 [7]
    82 [8]
    85 [9]
    Units: Percentage of ELLIPTA doses
        least squares mean (standard error)
    77.2 ± 3.04
    78.3 ± 3.11
    77.1 ± 3.25
    69.0 ± 3.19
    Notes
    [6] - ITT Population
    [7] - ITT Population
    [8] - ITT Population
    [9] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 = 0.016
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 14.9
    Notes
    [10] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 16
    Notes
    [11] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 = 0.018
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 14.8
    Notes
    [12] - p-value was calculated using ANCOVA.

    Secondary: Percentage of ELLIPTA doses taken (daily adherence) between Month 1 and Month 3 as determined by the maintenance sensor

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    End point title
    		 Percentage of ELLIPTA doses taken (daily adherence) between Month 1 and Month 3 as determined by the maintenance sensor
    End point description
    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentageof ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Month 1 to Month 3
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    86 [13]
    87 [14]
    88 [15]
    88 [16]
    86 [17]
    Units: Percentage of ELLIPTA doses
        least squares mean (standard error)
    85.7 ± 2.82
    84.2 ± 2.66
    82.0 ± 2.74
    79.2 ± 2.78
    76.4 ± 2.82
    Notes
    [13] - ITT Population
    [14] - ITT Population
    [15] - ITT Population
    [16] - ITT Population
    [17] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 15.3
    Notes
    [18] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.011
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 13.7
    Notes
    [19] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 = 0.066
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 11.4
    Notes
    [20] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.359
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 8.7
    Notes
    [21] - p-value was calculated using ANCOVA.

    Secondary: Percentage of ELLIPTA doses taken (daily adherence) between Month 1 and Month 6 as determined by the maintenance sensor

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    End point title
    		 Percentage of ELLIPTA doses taken (daily adherence) between Month 1 and Month 6 as determined by the maintenance sensor
    End point description
    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Month 1 to Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    86 [22]
    87 [23]
    88 [24]
    88 [25]
    86 [26]
    Units: Percentage of ELLIPTA doses
        least squares mean (standard error)
    81.5 ± 3.07
    78.8 ± 2.90
    77.7 ± 2.99
    75.2 ± 3.03
    71.8 ± 3.07
    Notes
    [22] - ITT Population
    [23] - ITT Population
    [24] - ITT Population
    [25] - ITT Population
    [26] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 16.3
    Notes
    [27] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    P-value
    		 = 0.032
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 13.5
    Notes
    [28] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 = 0.07
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 12.4
    Notes
    [29] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    P-value
    		 = 0.294
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 9.9
    Notes
    [30] - p-value was calculated using ANCOVA.

    Secondary: Percentage of rescue free days between Month 4 and Month 6 as determined by the rescue medication sensor

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    End point title
    		 Percentage of rescue free days between Month 4 and Month 6 as determined by the rescue medication sensor
    End point description
    Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. Only those participants with rescue data observed/imputed at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Month 4 to Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    87 [31]
    88 [32]
    88 [33]
    88 [34]
    85 [35]
    Units: Percentage of rescue free days
        least squares mean (standard error)
    81.1 ± 2.82
    81.2 ± 2.66
    85.6 ± 2.76
    83.7 ± 2.80
    76.4 ± 2.82
    Notes
    [31] - ITT Population
    [32] - ITT Population
    [33] - ITT Population
    [34] - ITT Population
    [35] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other [36]
    P-value
    		 = 0.118
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 10.8
    Notes
    [36] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.105
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 10.7
    Notes
    [37] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 15.1
    Notes
    [38] - p-value was calculated using ANCOVA.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    P-value
    		 = 0.015
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 13.2
    Notes
    [39] - p-value was calculated using ANCOVA.

    Secondary: Number of doses of rescue medication use between Month 4 and Month 6 as determined by the rescue medication sensor

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    End point title
    		 Number of doses of rescue medication use between Month 4 and Month 6 as determined by the rescue medication sensor
    End point description
    Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Month 4 to Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    83 [40]
    84 [41]
    85 [42]
    82 [43]
    85 [44]
    Units: Doses of rescue medication
        arithmetic mean (standard deviation)
    55.3 ± 107.73
    40.6 ± 91.53
    29.5 ± 54.41
    27.0 ± 45.27
    55.8 ± 158.49
    Notes
    [40] - ITT Population
    [41] - ITT Population
    [42] - ITT Population
    [43] - ITT Population
    [44] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in asthma control test (ACT) total score

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    End point title
    		 Change from Baseline in asthma control test (ACT) total score
    End point description
    The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as 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 latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    82 [45]
    82 [46]
    78 [47]
    78 [48]
    82 [49]
    Units: Scores on a Scale
        least squares mean (standard error)
    3.4 ± 0.40
    4.3 ± 0.40
    4.7 ± 0.41
    4.2 ± 0.41
    3.9 ± 0.40
    Notes
    [45] - ITT Population
    [46] - ITT Population
    [47] - ITT Population
    [48] - ITT Population
    [49] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [50]
    P-value
    		 = 0.4
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.6
    Notes
    [50] - p-value was calculated using Mixed Model Repeated Measures (MMRM).
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    P-value
    		 = 0.441
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 1.5
    Notes
    [51] - p-value was calculated using MMRM.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other [52]
    P-value
    		 = 0.164
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 1.9
    Notes
    [52] - p-value was calculated using MMRM.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other [53]
    P-value
    		 = 0.661
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 1.4
    Notes
    [53] - p-value was calculated using MMRM.

    Secondary: Percentage of participants attaining asthma control (percentage of participants with an ACT total score >=20) at Month 6

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    End point title
    		 Percentage of participants attaining asthma control (percentage of participants with an ACT total score >=20) at Month 6
    End point description
    Percentage of participants attaining asthma control was defined as participants with an ACT total score >=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as 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. Percentage of participants who attained asthma control at Month 6 is presented.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    87 [54]
    88 [55]
    88 [56]
    88 [57]
    86 [58]
    Units: Percentage of participants
    52
    66
    55
    53
    62
    Notes
    [54] - ITT Population
    [55] - ITT Population
    [56] - ITT Population
    [57] - ITT Population
    [58] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [59]
    P-value
    		 = 0.385
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.44
    Notes
    [59] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [60]
    P-value
    		 = 0.517
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 2.42
    Notes
    [60] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [61]
    P-value
    		 = 0.921
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.85
    Notes
    [61] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [62]
    P-value
    		 = 0.321
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.38
    Notes
    [62] - p-value was calculated using logistic regression

    Secondary: Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6

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    End point title
    		 Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6
    End point description
    The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as 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 latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6 is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    87 [63]
    88 [64]
    88 [65]
    88 [66]
    86 [67]
    Units: Percentage of participants
    61
    69
    65
    63
    64
    Notes
    [63] - ITT Population
    [64] - ITT Population
    [65] - ITT Population
    [66] - ITT Population
    [67] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [68]
    P-value
    		 = 0.911
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.98
    Notes
    [68] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [69]
    P-value
    		 = 0.383
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.54
    Notes
    [69] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [70]
    P-value
    		 = 0.814
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 2.04
    Notes
    [70] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [71]
    P-value
    		 = 0.986
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.89
    Notes
    [71] - p-value was calculated using logistic regression

    Secondary: Percentage of participants who have either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6

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    End point title
    		 Percentage of participants who have either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6
    End point description
    The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6 is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Number of subjects analysed
    87 [72]
    88 [73]
    88 [74]
    88 [75]
    86 [76]
    Units: Percentage of participants
    66
    75
    65
    67
    70
    Notes
    [72] - ITT Population
    [73] - ITT Population
    [74] - ITT Population
    [75] - ITT Population
    [76] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 1: Data on maintenance use supplied to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other [77]
    P-value
    		 = 0.833
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.81
    Notes
    [77] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 2: Data on maintenance use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [78]
    P-value
    		 = 0.383
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 2.67
    Notes
    [78] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 3: Data on maintenance and rescue use to Par and HCP v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [79]
    P-value
    		 = 0.628
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.63
    Notes
    [79] - p-value was calculated using logistic regression
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.
    Comparison groups
    Cohort 4: Data on maintenance and rescue use supplied to Par v Cohort 5: No data supplied to Par or HCP
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 other [80]
    P-value
    		 = 0.844
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.8
    Notes
    [80] - p-value was calculated using logistic regression

    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 up to 6 months
    Adverse event reporting additional description
    SAEs and non-serious AEs were reported for the ITT Population which comprised of all randomized participants, excluding those who were randomized in error.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Cohort 1: Data on maintenance use supplied to Par and HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.

    Reporting group title
    Cohort 2: Data on maintenance use supplied to Par
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.

    Reporting group title
    Cohort 3: Data on maintenance and rescue use to Par and HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.

    Reporting group title
    Cohort 4: Data on maintenance and rescue use supplied to Par
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.

    Reporting group title
    Cohort 5: No data supplied to Par or HCP
    Reporting group description
    		 Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.

    Serious adverse events
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 88 (1.14%)
    2 / 88 (2.27%)
    1 / 88 (1.14%)
    4 / 86 (4.65%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian germ cell teratoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    pneumonia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cohort 1: Data on maintenance use supplied to Par and HCP Cohort 2: Data on maintenance use supplied to Par Cohort 3: Data on maintenance and rescue use to Par and HCP Cohort 4: Data on maintenance and rescue use supplied to Par Cohort 5: No data supplied to Par or HCP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 87 (4.60%)
    1 / 88 (1.14%)
    1 / 88 (1.14%)
    1 / 88 (1.14%)
    2 / 86 (2.33%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    fatigue
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    0 / 86 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    1 / 86 (1.16%)
         occurrences all number
    0
    0
    0
    1
    1
    Infections and infestations
    Oral Candidiasis
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2018
    Amendment 01: Sections: synopsis, overall design, number of participants, scientific rationale for study design and method of treatment assignment were modified - sample size re-estimation and interim analysis were deleted. Updated schedule of activities-requirement to collect protocol defined safety events from start of run-in and once a participant has begun treatment with Relvar/Breo added to table and notes. Updated the section: benefit/risk assessment to remove potential risks to align with the latest risk management plan (RMP). Updated objectives and endpoints to delete prescriptions filled from healthcare utilization endpoints, to add asthma control test (ACT) composite endpoint, correction to asthma symptom utility index (ASUI) endpoint and correction to beliefs in medicine questionnaire (BMQ) endpoint. Section: overall design modified to clarify early withdrawal. Text amended in concomitant therapy, discontinuation criteria, BMQ, exit interviews, asthma exacerbations, biomarkers and prescription record for asthma maintenance medication.

    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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