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    Clinical Trial Results:
    Study 201012: A Dose-Finding Study of batefenterol (GSK961081) via Dry Powder Inhaler in Patients with COPD.

    Summary
    EudraCT number
    		 2015-001409-15
    Trial protocol
    		 DE  
    Global end of trial date
    06 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2017
    First version publication date
    19 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    201012
    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, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose response, efficacy and safety of five dosage regimens of batefenterol delivered via the DPI in participants with COPD.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 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
    Germany: 89
    Country: Number of subjects enrolled
    South Africa: 70
    Country: Number of subjects enrolled
    United States: 164
    Worldwide total number of subjects
    323
    EEA total number of subjects
    89
    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)
    183
    From 65 to 84 years
    140
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants (par.) with an established clinical history of Chronic Obstructive Pulmonary Disease (COPD), were included in this dose-finding study of batefenterol (BAT). Of 585 par. screened, 324 par. were randomized in the study, out of which one par. was randomized in error and was not included in the Intent-to-Treat analysis.

    Pre-assignment
    Screening details
    		 Pre-bronchodilator and post albuterol/salbutamol spirometry testing were performed at Screening visit. Post-albuterol/salbutamol (Forced expiratory Volume in One Second) FEV1 and FEV1/ (Forced Vital Capacity) FVC values were used to determine subject eligibility. Participants underwent 2 weeks run-in period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo drug was administered once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Arm title
    		 Batefenterol 37.5 µg
    Arm description
    		 Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Batefenterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Batefenterol of strengths 37.5 µg, 75 µg, 150 µg, 300 µg or 600 µg were administered to randomized participants once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Arm title
    		 Batefenterol 75 µg
    Arm description
    		 Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Batefenterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Batefenterol of strengths 37.5 µg, 75 µg, 150 µg, 300 µg or 600 µg were administered to randomized participants once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Arm title
    		 Batefenterol 150 µg
    Arm description
    		 Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Batefenterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Batefenterol of strengths 37.5 µg, 75 µg, 150 µg, 300 µg or 600 µg were administered to randomized participants once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Arm title
    		 Batefenterol 300 µg
    Arm description
    		 Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Batefenterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Batefenterol of strengths 37.5 µg, 75 µg, 150 µg, 300 µg or 600 µg were administered to randomized participants once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Arm title
    		 Batefenterol 600 µg
    Arm description
    		 Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Batefenterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Batefenterol of strengths 37.5 µg, 75 µg, 150 µg, 300 µg or 600 µg were administered to randomized participants once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Arm title
    		 UMEC/VI 62.5/25 µg
    Arm description
    		 Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    UMEC/VI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    UMEC/VI (62.5/25 µg) inhalation powder was administered once daily in the morning for 42 days in 2 strips via Dry Powder Inhaler (DPI)

    Number of subjects in period 1
    		Placebo Batefenterol 37.5 µg Batefenterol 75 µg Batefenterol 150 µg Batefenterol 300 µg Batefenterol 600 µg UMEC/VI 62.5/25 µg
    Started
    46
    46
    46
    45
    47
    46
    47
    Completed
    44
    43
    41
    40
    41
    44
    47
    Not completed
    2
    3
    5
    5
    6
    2
    0
         Physician decision
    -
    1
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    2
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    2
    -
    -
    -
    -
         Withdrawal Request by GSK
    -
    -
    2
    -
    -
    -
    -
         Par. Reached Stopping Criteria
    1
    1
    -
    2
    1
    1
    -
         Par. did not Meet Continuation Criteria
    -
    -
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    1
    -
    -
    -
         Lack of efficacy
    -
    1
    -
    -
    4
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.

    Reporting group title
    Batefenterol 37.5 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 75 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 150 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 300 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 600 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    UMEC/VI 62.5/25 µg
    Reporting group description
    		 Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.

    Reporting group values
    		 Placebo Batefenterol 37.5 µg Batefenterol 75 µg Batefenterol 150 µg Batefenterol 300 µg Batefenterol 600 µg UMEC/VI 62.5/25 µg Total
    Number of subjects
    		 46 46 46 45 47 46 47
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 61.1 ( 6.6 ) 61.9 ( 8.16 ) 63 ( 7.21 ) 63.6 ( 8.11 ) 61.9 ( 8.7 ) 63.7 ( 7.06 ) 62.8 ( 8.46 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 19 19 13 26 20 25 21 143
        Male
    		 27 27 33 19 27 21 26 180
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 6 3 3 2 4 3 2 23
        White
    		 38 35 40 35 40 38 39 265
        Multiple Geographic Ancestries
    		 2 8 3 8 3 5 6 35

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.

    Reporting group title
    Batefenterol 37.5 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 75 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 150 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 300 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 600 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    UMEC/VI 62.5/25 µg
    Reporting group description
    		 Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.

    Primary: Change from Baseline in Weighted Mean FEV1 over 0 to 6 hours post-dose at Day 42

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    End point title
    		 Change from Baseline in Weighted Mean FEV1 over 0 to 6 hours post-dose at Day 42
    End point description
    FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline and Day 42
    End point values
    		 Placebo Batefenterol 37.5 µg Batefenterol 75 µg Batefenterol 150 µg Batefenterol 300 µg Batefenterol 600 µg UMEC/VI 62.5/25 µg
    Number of subjects analysed
    44 [1]
    42 [2]
    41 [3]
    39 [4]
    41 [5]
    44 [6]
    47 [7]
    Units: Milliliters (mL)
        arithmetic mean (standard error)
    -9.9 ( 31.21 )
    181.2 ( 30.85 )
    221.68 ( 21.09 )
    251.87 ( 16.3 )
    271.47 ( 19.49 )
    282.94 ( 24.2 )
    275.43 ( 29.91 )
    Notes
    [1] - ITT Population.
    [2] - ITT Population.
    [3] - ITT Population.
    [4] - ITT Population.
    [5] - ITT Population.
    [6] - ITT Population.
    [7] - ITT Population.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.
    Comparison groups
    Batefenterol 37.5 µg v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    191.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 101.07
         upper limit
    		 284.26
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.
    Comparison groups
    Placebo v Batefenterol 75 µg
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    231.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 149.31
         upper limit
    		 310.02
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.
    Comparison groups
    Placebo v Batefenterol 150 µg
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    261.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 189.85
         upper limit
    		 332.25
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.
    Comparison groups
    Placebo v Batefenterol 300 µg
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    281.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 212.35
         upper limit
    		 351.3
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.
    Comparison groups
    Placebo v Batefenterol 600 µg
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    292.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 223.02
         upper limit
    		 364.42

    Secondary: Change from Baseline in Trough FEV1 at Day 42

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    End point title
    		 Change from Baseline in Trough FEV1 at Day 42
    End point description
    Trough FEV1 at Day 42 is the mean volume of air that can be forced out in one second after taking a deep breath at the approximately 23 Hrs and 24 Hrs assessments after the last administration of study drug. Batefenterol dose for each individual was compared with placebo or UMEC/VI. Change from Baseline was calculated as trough FEV1 on Day 42 minus baseline, where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The Maximum Likelihood Estimation (MLE) method of dose response modeling with Emax modeling without Bayesian priors was used. Participants with FEV1 values available at Baseline and Day 42 after 24 hrs after the last administration of study drug were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 42
    End point values
    		 Placebo Batefenterol 37.5 µg Batefenterol 75 µg Batefenterol 150 µg Batefenterol 300 µg Batefenterol 600 µg UMEC/VI 62.5/25 µg
    Number of subjects analysed
    44 [8]
    43 [9]
    41 [10]
    40 [11]
    41 [12]
    44 [13]
    47 [14]
    Units: mL
        arithmetic mean (standard error)
    -35.7 ( 30.8 )
    146.5 ( 28.3 )
    160.8 ( 15.6 )
    168.9 ( 15 )
    173.2 ( 18.2 )
    175.4 ( 20.5 )
    209 ( 29.8 )
    Notes
    [8] - ITT Population
    [9] - ITT Population
    [10] - ITT Population
    [11] - ITT Population
    [12] - ITT Population
    [13] - ITT Population
    [14] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.
    Comparison groups
    Batefenterol 37.5 µg v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    182.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 99.8
         upper limit
    		 264.6
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.
    Comparison groups
    Batefenterol 75 µg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    196.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 128.4
         upper limit
    		 264.8
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.
    Comparison groups
    Batefenterol 150 µg v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    204.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 137.2
         upper limit
    		 272.1
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.
    Comparison groups
    Batefenterol 300 µg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    208.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 138.7
         upper limit
    		 279.2
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.
    Comparison groups
    Batefenterol 600 µg v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    211.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 138.6
         upper limit
    		 283.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
    Adverse event reporting additional description
    AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.

    Reporting group title
    Batefenterol 75 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.

    Reporting group title
    Batefenterol 37.5 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 150 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 300 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    Batefenterol 600 µg
    Reporting group description
    		 Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.

    Reporting group title
    UMEC/VI 62.5/25 µg
    Reporting group description
    		 Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.

    Serious adverse events
    		 Placebo Batefenterol 75 µg Batefenterol 37.5 µg Batefenterol 150 µg Batefenterol 300 µg Batefenterol 600 µg UMEC/VI 62.5/25 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Infections and infestations
    Scrotal abscess
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo Batefenterol 75 µg Batefenterol 37.5 µg Batefenterol 150 µg Batefenterol 300 µg Batefenterol 600 µg UMEC/VI 62.5/25 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 46 (4.35%)
    8 / 46 (17.39%)
    3 / 46 (6.52%)
    5 / 45 (11.11%)
    7 / 47 (14.89%)
    18 / 46 (39.13%)
    4 / 47 (8.51%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    1
    0
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    2 / 45 (4.44%)
    1 / 47 (2.13%)
    6 / 46 (13.04%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    6
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    2 / 45 (4.44%)
    4 / 47 (8.51%)
    5 / 46 (10.87%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    1
    2
    4
    5
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 46 (6.52%)
    1 / 46 (2.17%)
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    3 / 46 (6.52%)
    0 / 47 (0.00%)
         occurrences all number
    2
    3
    1
    1
    0
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    2 / 46 (4.35%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    0
    2
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2015
    To correct IND number on the Sponsor Information page.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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