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    Clinical Trial Results:
    A pilot double-blind, placebo-controlled, 2 period crossover clinical study to assess the effect of aclidinium bromide 400 μg BID on COPD symptoms and sleep quality after 3 weeks of treatment in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)

    Summary
    EudraCT number
    2013-003373-10
    Trial protocol
    DE  
    Global end of trial date
    02 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Jun 2016
    First version publication date
    17 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M/34273/47
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02153489
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    2 Kingdom St, London, United Kingdom, W2 6BD
    Public contact
    Study Director, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Study Director, AstraZeneca, ClinicalTrialTransparency@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
    02 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2015
    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 objectives of this study were to assess the effect of aclidinium bromide versus placebo in improving bronchodilation, chronic obstructive pulmonary disease (COPD) symptoms, sleep quality and physical activity after 3 weeks of treatment in patients with stable moderate and severe COPD and to assess the safety and tolerability of aclidinium bromide 400 μg administered twice daily (BID) in the same target population
    Protection of trial subjects
    This study was conducted in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly of Helsinki (1964), revised at Tokyo (1975), Venice (1983), Hong-Kong (1989) and Somerset West (1996) as well as in compliance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Patients were provided with relief medication, salbutamol pressurised metered dose inhaler (pMDI), 100 μg/puff, which could be used on from the time of signing of the informed consent until the end of treatment period
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Apr 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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    15
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted by 3 investigators at 3 sites in Germany. The first patient was screened in April 2015 and the last patient visit was in June 2015

    Pre-assignment
    Screening details
    All patients who met the study entry criteria and completed the screening assessments and the 7-day run-in period were randomised. Nine (9/39) subjects were not randomized due to screening failure (primarily for non-fulfillment of inclusion/exclusion criteria)

    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
    Sequence A
    Arm description
    Aclidinium 400 μg - Placebo
    Arm type
    Experimental

    Investigational medicinal product name
    Aclidinium bromide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    400 μg twice-daily (BID)

    Arm title
    Sequence B
    Arm description
    Placebo - Aclidinium 400 μg
    Arm type
    Experimental

    Investigational medicinal product name
    Aclidinium bromide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    400 μg twice-daily (BID)

    Number of subjects in period 1
    Sequence A Sequence B
    Started
    15
    15
    Started Period 1
    15
    15
    Completed Period 1
    15
    15
    Started Period 2
    15
    15
    Completed Period 2
    15
    15
    Completed
    15
    15

    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
    30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    15 15
        Elderly (From 65-84 years)
    15 15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.4 ± 7 -
    Gender categorical
    Units: Subjects
        Female
    15 15
        Male
    15 15

    End points

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    End points reporting groups
    Reporting group title
    Sequence A
    Reporting group description
    Aclidinium 400 μg - Placebo

    Reporting group title
    Sequence B
    Reporting group description
    Placebo - Aclidinium 400 μg

    Subject analysis set title
    Aclidinium
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Aclidinium bromide 400 ug BID

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Placebo BID

    Primary: Change from baseline in normalised forced expiratory volume in one second (FEV1) AUC0-24hr

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    End point title
    Change from baseline in normalised forced expiratory volume in one second (FEV1) AUC0-24hr
    End point description
    End point type
    Primary
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: L/sec.hr
        least squares mean (standard error)
    0.0953 ± 0.0381
    -0.0429 ± 0.0381
    Statistical analysis title
    Aclidinium v Placebo
    Comparison groups
    Aclidinium v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0035
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.1382
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.0515
         upper limit
    0.225
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0415

    Other pre-specified: Change from baseline in morning trough FEV1

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    End point title
    Change from baseline in morning trough FEV1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Litres/sec
        least squares mean (standard error)
    0.1128 ± 0.0395
    -0.0106 ± 0.0395
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in peak FEV1

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    End point title
    Change from baseline in peak FEV1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Litres/sec
        least squares mean (standard error)
    0.1605 ± 0.0391
    -0.0149 ± 0.0391
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in normalised FEV1 AUC0-12hr

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    End point title
    Change from baseline in normalised FEV1 AUC0-12hr
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: L/sec.hr
        least squares mean (standard error)
    0.1394 ± 0.0406
    -0.01 ± 0.0406
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in normalised FEV1 AUC12-24hr

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    End point title
    Change from baseline in normalised FEV1 AUC12-24hr
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: L/sec.hr
        least squares mean (standard error)
    0.0513 ± 0.0369
    -0.0758 ± 0.0369
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in the average rating of COPD symptoms limiting early morning activities

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    End point title
    Change from baseline in the average rating of COPD symptoms limiting early morning activities
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Score
        arithmetic mean (standard deviation)
    -0.02 ± 0.457
    0.16 ± 0.43
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in the average rating of overall early morning COPD symptom severity

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    End point title
    Change from baseline in the average rating of overall early morning COPD symptom severity
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Score
        arithmetic mean (standard deviation)
    -0.07 ± 0.575
    0.09 ± 0.476
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in the average rating of COPD symptoms limiting evening activities

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    End point title
    Change from baseline in the average rating of COPD symptoms limiting evening activities
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Score
        arithmetic mean (standard deviation)
    -0.18 ± 0.488
    0.03 ± 0.45
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in the average rating of overall evening COPD symptom severity

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    End point title
    Change from baseline in the average rating of overall evening COPD symptom severity
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Score
        arithmetic mean (standard deviation)
    -0.15 ± 0.661
    0.11 ± 0.559
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in the average rating of overall night-time COPD symptom severity

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    End point title
    Change from baseline in the average rating of overall night-time COPD symptom severity
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Score
        arithmetic mean (standard deviation)
    -0.14 ± 0.612
    -0.03 ± 0.526
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in duration of at least moderate activity

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    End point title
    Change from baseline in duration of at least moderate activity
    End point description
    Moderate activity was defined as any physical activity >3 metabolic equivalents
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Minutes
        least squares mean (standard error)
    9.446 ± 6.7081
    -8.5943 ± 6.5879
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in number of steps

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    End point title
    Change from baseline in number of steps
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Steps
        least squares mean (standard error)
    268.5891 ± 326.3649
    22.2652 ± 320.6754
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in oxygen desaturation index (ODI) per hour of total sleep time

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    End point title
    Change from baseline in oxygen desaturation index (ODI) per hour of total sleep time
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: /hr
        least squares mean (standard error)
    -0.3033 ± 0.9754
    2.24 ± 0.9754
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in sleep efficiency

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    End point title
    Change from baseline in sleep efficiency
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Percentage
        least squares mean (standard error)
    1 ± 2.4046
    -2.55 ± 2.4046
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in sleep stage REM

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    End point title
    Change from baseline in sleep stage REM
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Percentage
        arithmetic mean (standard error)
    1.41 ± 0.9851
    -1.1167 ± 0.9851
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in total sleep time

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    End point title
    Change from baseline in total sleep time
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: Minutes
        least squares mean (standard error)
    6.92 ± 11.5802
    -11.85 ± 11.5802
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in apnea-hypopnea index (AHI) per hour of total sleep time

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    End point title
    Change from baseline in apnea-hypopnea index (AHI) per hour of total sleep time
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Week 3 of treatment
    End point values
    Aclidinium Placebo
    Number of subjects analysed
    30
    30
    Units: /hr
        least squares mean (standard error)
    0.4767 ± 0.4478
    0.77 ± 0.4478
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days after last study drug administration
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo BID

    Reporting group title
    Aclidinium
    Reporting group description
    Aclidinium bromide 400 μg BID

    Serious adverse events
    Placebo Aclidinium
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Aclidinium
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3

    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
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