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    Clinical Trial Results:
    A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg compared with Glycopyrronium 44 mcg in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

    Summary
    EudraCT number
    		 2014-000885-23
    Trial protocol
    		 SE   DE   ES   HU   CZ  
    Global end of trial date
    02 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2016
    First version publication date
    27 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    201315
    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
    23 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare the efficacy and safety of umeclidinium (UMEC) 62.5 micrograms (mcg) with glycopyrronium (GLYCO) 44 mcg in subjects with COPD over 12 weeks of treatment.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2014
    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
    Argentina: 103
    Country: Number of subjects enrolled
    Chile: 174
    Country: Number of subjects enrolled
    Czech Republic: 131
    Country: Number of subjects enrolled
    Germany: 185
    Country: Number of subjects enrolled
    Hungary: 104
    Country: Number of subjects enrolled
    Norway: 93
    Country: Number of subjects enrolled
    Romania: 97
    Country: Number of subjects enrolled
    Russian Federation: 309
    Country: Number of subjects enrolled
    Spain: 57
    Country: Number of subjects enrolled
    Sweden: 99
    Worldwide total number of subjects
    1352
    EEA total number of subjects
    766
    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)
    668
    From 65 to 84 years
    673
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 1290 par. were screened; 1037 par. were randomized and 1034 were in the ITT population which comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Two par. were randomized in error and one par. was randomized, but did not take any study medication.

    Pre-assignment
    Screening details
    		 Participants (par.), with clinical history of chronic obstructive pulmonary disease, who meet the eligibility criteria at screening were enrolled in a 7 to 14 day run-in period. Par. meeting continuation criteria, during run-in period, were randomized (1:1) to receive umeclidinium or glycopyrronium.

    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
    		 UMEC 62.5 mcg QD
    Arm description
    		 Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Umeclidinium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single dose of umeclidinium (UMEC) 62.5 microgram (mcg) in morning via dry powder inhaler for 12 weeks

    Arm title
    		 GLYCO 44 mcg QD
    Arm description
    		 Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glycopyrronium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single dose of glycopyrronium bromide (GLYCO) 44 mcg in morning via dry powder inhaler for 12 weeks

    Number of subjects in period 1 [1]
    		UMEC 62.5 mcg QD GLYCO 44 mcg QD
    Started
    516
    518
    Completed
    490
    484
    Not completed
    26
    34
         Adverse event, serious fatal
    1
    2
         Adverse event, non-fatal
    9
    14
         Protocol deviation
    3
    5
         Withdrew consent
    9
    4
         Lost to follow-up
    -
    2
         Lack of efficacy
    4
    7
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 1290 par. were screened; 1037 par. were randomized and 1034 were in the intent-to-treat ITT population which comprised all par. randomized to treatment who received at least one dose of randomized study medication. Two par. were randomized in error and 1 par. was randomized, but did not take any study medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UMEC 62.5 mcg QD
    Reporting group description
    		 Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.

    Reporting group title
    GLYCO 44 mcg QD
    Reporting group description
    		 Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.

    Reporting group values
    		 UMEC 62.5 mcg QD GLYCO 44 mcg QD Total
    Number of subjects
    		 516 518 1034
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 8.35 ) 64 ( 8.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 161 168 329
        Male
    		 355 350 705
    Race, Customized
    Units: Subjects
        Central/South Asian Heritage (HRTG)
    		 3 0 3
        Japanese/East Asian Heritage/South East Asian HRTG
    		 0 1 1
        White
    		 513 517 1030

    End points

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    End points reporting groups
    Reporting group title
    UMEC 62.5 mcg QD
    Reporting group description
    		 Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.

    Reporting group title
    GLYCO 44 mcg QD
    Reporting group description
    		 Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.

    Primary: Change from Baseline in trough FEV1 on Day 85

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    End point title
    		 Change from Baseline in trough FEV1 on Day 85
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the Baseline value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here. Per Protocol (PP) Population: Participants in the Intent-To-Treat (ITT) Population who did not have a full protocol deviation considered to impact efficacy.
    End point type
    Primary
    End point timeframe
    Baseline (BL) and Day 85
    End point values
    		 UMEC 62.5 mcg QD GLYCO 44 mcg QD
    Number of subjects analysed
    431 [1]
    425 [2]
    Units: Liter
        least squares mean (standard error)
    0.123 ( 0.0105 )
    0.099 ( 0.0105 )
    Notes
    [1] - PP population
    [2] - PP population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Participants represent those with data available at time point presented; however, all participants in the PP population without missing covariate information and >=1 post Baseline measurement are included in analysis.
    Comparison groups
    UMEC 62.5 mcg QD v GLYCO 44 mcg QD
    Number of subjects included in analysis
    856
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.005
         upper limit
    		 0.054
    Notes
    [3] - Alternate hypothesis: the difference between the treatment means (umeclidinium minus glycopyrronium) would be > -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks).
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    GLYCO 44 mcg QD
    Reporting group description
    		 Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.

    Reporting group title
    UMEC 62.5 mcg QD
    Reporting group description
    		 Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.

    Serious adverse events
    		 GLYCO 44 mcg QD UMEC 62.5 mcg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 518 (2.90%)
    17 / 516 (3.29%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Laryngeal cancer
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 518 (0.19%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sudden death
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    0 / 518 (0.00%)
    1 / 516 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    5 / 518 (0.97%)
    7 / 516 (1.36%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 518 (0.00%)
    2 / 516 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 518 (0.19%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 GLYCO 44 mcg QD UMEC 62.5 mcg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 518 (15.44%)
    77 / 516 (14.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    51 / 518 (9.85%)
    42 / 516 (8.14%)
         occurrences all number
    86
    70
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    39 / 518 (7.53%)
    42 / 516 (8.14%)
         occurrences all number
    42
    43

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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