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    Clinical Trial Results:
    A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF TWICE-DAILY ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE COMPARED WITH TWICE-DAILY SALMETEROL/FLUTICASONE PROPIONATE FOR 24-WEEKS TREATMENT IN SYMPTOMATIC PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

    Summary
    EudraCT number
    2013-000116-14
    Trial protocol
    HU   GB   IT   LT   CZ   AT   ES   NL   BG  
    Global end of trial date
    04 Aug 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    M-40464-39
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01908140
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Avenida Diagonal 615, 2nd Floor, Barcelona, Spain, 08028
    Public contact
    Senior Director, Clinical Development, AstraZeneca, esther.garciagil@astrazeneca.com
    Scientific contact
    Study Information Center, AstraZeneca Barcelona, information.center@astrazeneca.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
    04 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate 400 μg/12 μg and salmeterol/fluticasone propionate 50/500 μg in patients with chronic obstructive pulmonary disease (COPD)
    Protection of trial subjects
    This study was performed according to the regulations of each country where it was carried out, the directives of the Declaration of Helsinki for biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki (1964), revised at Tokyo (1975), Venice (1983), Hong Kong (1989), Somerset West (1996) and Edinburgh (2000) including the Notes of clarification made by the World Medical Assembly (WMA) of Washington (2002) and Tokyo (2004), and the 59th WMA General Assembly, Seoul (2008), as well as in compliance with the guidelines of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local regulations Every patient was provided with sufficient salbutamol for inhalation (pMDI 100μg/puff) to be used as relief medication during the study. Administration was on as needed basis, as per the investigator’s instructions in accordance with the clinical status of the patient
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 47
    Country: Number of subjects enrolled
    Bulgaria: 62
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Czech Republic: 25
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 254
    Country: Number of subjects enrolled
    Hungary: 98
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Lithuania: 27
    Country: Number of subjects enrolled
    Netherlands: 22
    Country: Number of subjects enrolled
    Poland: 122
    Country: Number of subjects enrolled
    South Africa: 134
    Country: Number of subjects enrolled
    Spain: 62
    Country: Number of subjects enrolled
    United Kingdom: 37
    Worldwide total number of subjects
    933
    EEA total number of subjects
    781
    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)
    550
    From 65 to 84 years
    382
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 140 activated sites. A total of 121 sites randomised patients. The first patient was screened in Oct 2013 and the last patient visit was in Aug 2014.

    Pre-assignment
    Screening details
    Patients fulfilling inclusion/exclusion criteria at the time of the screening visit were entered into a run-in period of 14-21 days to assess disease stability.

    Pre-assignment period milestones
    Number of subjects started
    933
    Number of subjects completed
    933

    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
    Aclidinium Bromide / Formoterol Fumarate
    Arm description
    Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Aclidinium Bromide / Formoterol Fumarate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    400μg/12μg BID

    Arm title
    Salmeterol / Fluticasone
    Arm description
    Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
    Arm type
    Active comparator

    Investigational medicinal product name
    Salmeterol / Fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50μg/500μg BID

    Number of subjects in period 1
    Aclidinium Bromide / Formoterol Fumarate Salmeterol / Fluticasone
    Started
    468
    465
    Completed
    402
    386
    Not completed
    66
    79
         Protocol deviation
    8
    9
         Lack of efficacy
    7
    5
         Other or Progressive Disease
    5
    12
         Adverse event, non-fatal
    22
    23
         Consent withdrawn by subject
    23
    24
         Lost to follow-up
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    -

    Reporting group values
    Overall study Total
    Number of subjects
    933 933
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    550 550
        From 65-84 years
    382 382
        85 years and over
    1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.4 ± 7.8 -
    Gender, Male/Female
    Units: participants
        Female
    326 326
        Male
    607 607

    End points

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    End points reporting groups
    Reporting group title
    Aclidinium Bromide / Formoterol Fumarate
    Reporting group description
    Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks

    Reporting group title
    Salmeterol / Fluticasone
    Reporting group description
    Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

    Subject analysis set title
    Aclidinium Bromide / Formoterol Fumarate
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks

    Subject analysis set title
    Salmeterol / Fluticasone
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

    Primary: Peak forced expiratory volume in one second (FEV1) at week 24

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    End point title
    Peak forced expiratory volume in one second (FEV1) at week 24
    End point description
    Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
    End point type
    Primary
    End point timeframe
    At Week 24
    End point values
    Aclidinium Bromide / Formoterol Fumarate Salmeterol / Fluticasone
    Number of subjects analysed
    357
    344
    Units: Liters
        least squares mean (standard error)
    1.66 ± 0.011
    1.559 ± 0.011
    Statistical analysis title
    Peak FEV1 at week 24
    Statistical analysis description
    This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0.055 L
    Comparison groups
    Aclidinium Bromide / Formoterol Fumarate v Salmeterol / Fluticasone
    Number of subjects included in analysis
    701
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    Least squares mean difference
    Point estimate
    0.101
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.07
         upper limit
    0.131
    Variability estimate
    Standard deviation
    Notes
    [1] - non-inferiority margin=-0.055 L

    Secondary: Transition Dyspnoea Index (TDI) focal score at week 24

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    End point title
    Transition Dyspnoea Index (TDI) focal score at week 24
    End point description
    The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 (“major deterioration”) to zero (“no change”) to +3 (“major improvement”). Category scores are added to compute the Focal Score (from -9 to 9)
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Aclidinium Bromide / Formoterol Fumarate Salmeterol / Fluticasone
    Number of subjects analysed
    353
    341
    Units: TDI Focal Score
        least squares mean (standard error)
    1.877 ± 0.171
    1.878 ± 0.173
    Statistical analysis title
    TDI focal score at week 24
    Statistical analysis description
    The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0.5
    Comparison groups
    Aclidinium Bromide / Formoterol Fumarate v Salmeterol / Fluticasone
    Number of subjects included in analysis
    694
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    P-value
    > 0.05
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.001
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.461
         upper limit
    0.459
    Notes
    [2] - non-inferiority limit -0.5 units

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 Weeks treatment + 2 weeks follow-up (±3 days)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Aclidinium Bromide / Formoterol Fumarate
    Reporting group description
    Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks

    Reporting group title
    Salmeterol / Fluticasone
    Reporting group description
    Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

    Serious adverse events
    Aclidinium Bromide / Formoterol Fumarate Salmeterol / Fluticasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 467 (7.49%)
    33 / 466 (7.08%)
         number of deaths (all causes)
    3
    1
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 467 (0.00%)
    2 / 466 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of head
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizoaffective disorder depressive
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine prolapse
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adnexa uteri mass
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grastroenteritis radiation
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 467 (0.00%)
    2 / 466 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary Artery Disease
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial Infarction
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Artrial fibrillation
         subjects affected / exposed
    1 / 467 (0.21%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Artrial flutter
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arrhythmogenic right ventricular dysp
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    COPD (exacerbation)
         subjects affected / exposed
    13 / 467 (2.78%)
    8 / 466 (1.72%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 467 (0.43%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 467 (0.21%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Hiatus hernia
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder disorder
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (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
    Malnutrition
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Endometritis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 467 (0.43%)
    4 / 466 (0.86%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract and infection
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Aclidinium Bromide / Formoterol Fumarate Salmeterol / Fluticasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    124 / 467 (26.55%)
    135 / 466 (28.97%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    70 / 467 (14.99%)
    75 / 466 (16.09%)
         occurrences all number
    82
    81
    Nervous system disorders
    Headache
         subjects affected / exposed
    28 / 467 (6.00%)
    32 / 466 (6.87%)
         occurrences all number
    42
    46
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    26 / 467 (5.57%)
    28 / 466 (6.01%)
         occurrences all number
    30
    33

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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