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    Clinical Trial Results:
    A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis

    Summary
    EudraCT number
    		 2008-001530-27
    Trial protocol
    		 GB   DE   SE   DK  
    Global end of trial date
    20 Jan 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2016
    First version publication date
    24 Feb 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D0520C00009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D Charnwood
    Sponsor organisation address
    Bakewell Road, Loughborough,, United Kingdom,
    Public contact
    Kulasiri Gunawardena MD, AstraZeneca R&D Charnwood, LE11 5RH. +44 1509 647103,
    Scientific contact
    Professor Stuart Elborn MD, Belfast City Hospital, BT9 7AB. +44 289 0329241,
    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
    20 Jan 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to investigate whether AZD9668 showed evidence of efficacy in CF patients by investigation of: • Absolute and differential neutrophil count in induced sputum. • Signs and symptoms of CF (including effects on Quality of Life [QoL])
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2008
    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: 13
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Sweden: 13
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    55
    EEA total number of subjects
    41
    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)
    55
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient enrolled: 30 October 2008 . Last patient last visit: 04 August 2009. Fifteen centres across 6 countries participated in this study: Denmark (4), Germany (13), Poland (6),Russia (14), Sweden(13)and United Kingdom (5)

    Pre-assignment
    Screening details
    		 506 patients enrolled were not randomized due to eligibility not fulfilled (10 patients), voluntary discontinuation (1 patient) and Adverse event (2)

    Period 1
    Period 1 title
    Overrall 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
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet to AZD9668

    Arm title
    		 AZD9668
    Arm description
    		 60 mg bd [twice daily]
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD9668
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30mg ,twice a day

    Number of subjects in period 1
    		Placebo AZD9668
    Started
    29
    26
    Completed
    27
    24
    Not completed
    2
    2
         Voluntary Discontinuation by Subject
    -
    1
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    AZD9668
    Reporting group description
    		 60 mg bd [twice daily]

    Reporting group values
    		 Placebo AZD9668 Total
    Number of subjects
    		 29 26
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27 ± 8.5 29 ± 10 -
    Gender Categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 29 25 54
    Subject analysis sets

    Subject analysis set title
    Efficacy Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set comprised all patients randomised into the study, who received at least one dose of study medication and had at least one piece of evaluable data.

    Subject analysis sets values
    		 Efficacy Analysis Set
    Number of subjects
    54
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    28 ± 9.2
    Gender Categorical
    Units: Subjects
        Female
    1
        Male
    53

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    AZD9668
    Reporting group description
    		 60 mg bd [twice daily]

    Subject analysis set title
    Efficacy Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set comprised all patients randomised into the study, who received at least one dose of study medication and had at least one piece of evaluable data.

    Primary: Absolute neutrophil counts in sputum

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    End point title
    		 Absolute neutrophil counts in sputum
    End point description
    The end point was the arithmetic mean of the counts in the end of the treatment samples (Visit 3a and 4)
    End point type
    Primary
    End point timeframe
    Baseline and End of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    28
    24
    Units: 10^6/g
        geometric mean (geometric coefficient of variation)
    9 ± 227.728
    13.95 ± 105.813
    Statistical analysis title
    		 absolute sputum neutrophils
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.891
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of AZD9668 to Placebo
    Point estimate
    0.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.38

    Primary: percentage neutrophil counts in sputum

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    End point title
    		 percentage neutrophil counts in sputum
    End point description
    The endpoint was the arithmetic mean of the counts in the end of treatment samples (Visits 3a and 4).
    End point type
    Primary
    End point timeframe
    End of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    28
    24
    Units: percent
        arithmetic mean (standard deviation)
    90.19 ± 16.628
    96.48 ± 3.931
    Statistical analysis title
    		 % sputum neutrophils
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.581
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.53
         upper limit
    		 5.04

    Primary: Peak Expiratory Flow

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    End point title
    		 Peak Expiratory Flow
    End point description
    The endpoint was the difference between the mean of theassessment for the last 7 days of the treatment period and themean of the last 7 days before the first day of dosing (baseline).
    End point type
    Primary
    End point timeframe
    Baseline and post treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    24
    Units: L/min
    arithmetic mean (standard deviation)
        PEF morning
    8.38 ± 34.187
    -4.83 ± 36.81
        PEF evening
    3.15 ± 28.252
    -2.29 ± 33.586
    Statistical analysis title
    		 BronkoTest© diary card variables: PEF morning
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.143
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -32.37
         upper limit
    		 1.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.21
    Statistical analysis title
    		 BronkoTest© diary card variable PEF Evening
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.516
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.72
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -20.39
         upper limit
    		 8.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.735

    Primary: Summary of change from baseline in BronkoTest© diary card variables

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    End point title
    		 Summary of change from baseline in BronkoTest© diary card variables
    End point description
    The endpoint was the difference between the mean of theassessment for the last 7 days of the treatment period and themean of the last 7 days before the first day of dosing (baseline).
    End point type
    Primary
    End point timeframe
    Baseline and End of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    25
    Units: uints on a scale
    arithmetic mean (standard deviation)
        Night-Time Symptom Score
    0.17 ± 0.668
    0.11 ± 0.406
        Describe Your Breathing
    0.04 ± 0.229
    0.11 ± 0.395
        Sputum Colour
    0 ± 0.277
    -0.16 ± 1.011
        Sputum Amout
    0 ± 0.332
    0.05 ± 0.509
        Sputum Type
    0.04 ± 0.365
    0.06 ± 0.341
        How do you feel
    0.02 ± 0.38
    0.11 ± 0.417
        How often do you cough
    0.01 ± 0.377
    0.11 ± 0.297
        Reliever Medication Taken Today
    -0.19 ± 0.78
    0.04 ± 0.175
    Statistical analysis title
    		 change from baseline in Night-Time Symptom Score
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.373
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.154
    Statistical analysis title
    		 Change from Baseline in Describe Your Breathing
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.093
    Statistical analysis title
    		 Change from Baseline in Sputum Colour
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.612
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Change from Baseline in Sputum Amount
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.234
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.125
    Statistical analysis title
    		 Change from Baseline in Sputum Type
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.581
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.096
    Statistical analysis title
    		 Change from baseline in How do you feel
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.413
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.106
    Statistical analysis title
    		 Change from Baseline in How often do you cough
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.195
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.101
    Statistical analysis title
    		 Reliever Medication Taken Today
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.887
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.083

    Primary: Change from Baseline for the Cystic Fibrosis Questionnaire data

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    End point title
    		 Change from Baseline for the Cystic Fibrosis Questionnaire data
    End point description
    The endpointis change from baseline (Visit 2) at Visit 4.
    End point type
    Primary
    End point timeframe
    Baseline and Visit 4
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    25
    Units: units on a scale
    arithmetic mean (standard deviation)
        Overall Score
    1 ± 56.65
    -8.7 ± 86.78
        Physical
    -1.3 ± 7.27
    -3.6 ± 13.63
        Vitality
    -0.9 ± 13.67
    1.9 ± 12.32
        Emotion
    3 ± 11.23
    1.2 ± 10.26
        Eat
    2.8 ± 7.17
    -1 ± 10.23
        Treatment Burden
    4 ± 13.93
    1.5 ± 12.5
        Health Perceptions
    -2.8 ± 14.06
    -1.5 ± 12.5
        Social
    -4.8 ± 11.29
    -3.5 ± 11.18
        Body
    0.8 ± 17.87
    -0.5 ± 12.11
        Role
    -0.3 ± 8.17
    1.6 ± 11.37
        Weight
    -2.5 ± 26.03
    -7.9 ± 34.81
        Respiratory
    1 ± 8.99
    0 ± 13.17
        Digestion
    4.1 ± 11.99
    2 ± 11.7
    Statistical analysis title
    		 Change from Baseline in Overall Score
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.293
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -24.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -62.9
         upper limit
    		 14.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    22.87
    Statistical analysis title
    		 Change from baselin in Physical
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.344
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 2.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    		 Change from Baseline in Emotion
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.52
    Statistical analysis title
    		 Change from Baseline in Eat
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.081
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.24
    Statistical analysis title
    		 Change from Baseline in Treatment Burden
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.368
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.16
    Statistical analysis title
    		 Change from Baseline in Health Perceptions
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.869
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 6.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.08
    Statistical analysis title
    		 Change from Baseline in Social
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.938
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 6.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.61
    Statistical analysis title
    		 Change from Baseline in Body
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11.9
         upper limit
    		 2.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.33
    Statistical analysis title
    		 Change from Baseline in Role
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.775
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 4.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.09
    Statistical analysis title
    		 Change from Baseline in Weight
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.331
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -19.8
         upper limit
    		 5.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.44
    Statistical analysis title
    		 Change from Baseline in Respirtory
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.611
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 4
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.43
    Statistical analysis title
    		 Change from Baseline in Digestion
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.676
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 3.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.08

    Primary: Change from Baseline in 24-hour sputum weight

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    End point title
    		 Change from Baseline in 24-hour sputum weight
    End point description
    Patients were asked to collect sputum for a 24 hour periodbefore Visit 1a and Visit 4. The endpoint was change frombaseline (Visit 1a) at Visit 4.
    End point type
    Primary
    End point timeframe
    visit 1a and visit 4
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    27
    24
    Units: gram
        arithmetic mean (standard deviation)
    -4.34 ± 12.206
    -5.19 ± 11.922
    Statistical analysis title
    		 Change from Baseline in 24-hour Sputum Weight
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.341
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.83
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.11
         upper limit
    		 7.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.94

    Primary: Change from Baseline in Lung Function test

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    End point title
    		 Change from Baseline in Lung Function test
    End point description
    Change from baseline (Visit 2) at the end of treatment (Visit 4) was the endpoint.
    End point type
    Primary
    End point timeframe
    visit 2 and visit4
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    25
    Units: Liter L/s %
    arithmetic mean (standard deviation)
        FEV1(L)
    -0.01 ± 0.212
    0 ± 0.199
        SVC(L)
    -0.12 ± 0.32
    0.04 ± 0.468
        FVC(L)
    -0.01 ± 0.265
    0 ± 0.361
        FEF25-75 (L/s)
    0.08 ± 0.46
    -0.04 ± 0.255
        % Predicted FEV1 (%)
    -0.15 ± 4.872
    -0.26 ± 5.089
    Statistical analysis title
    		 Change from Baseline in FEV1
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.651
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.062
    Statistical analysis title
    		 Chnage from Baseline in SVC
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.364
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.125
    Statistical analysis title
    		 Change from Baseline in FEF25-75
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.231
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.118
    Statistical analysis title
    		 Change from Baseline in FVC
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.412
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.085
    Statistical analysis title
    		 Change from Baseline in % Predicted FEV1
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.451
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.53
         upper limit
    		 1.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.445

    Secondary: sputum neutrophil elastase activity

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    End point title
    		 sputum neutrophil elastase activity
    End point description
    Assay of NE activity in induced sputum collections at Visits 1a,2, 3a and 4. The endpoint was end of treatment data (mean ofVisits 3a and 4).
    End point type
    Secondary
    End point timeframe
    end of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    21
    17
    Units: μmol/L AMC/hr
        geometric mean (geometric coefficient of variation)
    106.67 ± 746
    148.4 ± 375
    Statistical analysis title
    		 Ratio of AZD9668 over Placebo
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on logtransformed data. The table presents the results back-transformed after the analysis on the original scale. If ratio CI contains 1, there is no evidence of a difference between AZD9668 and Placebo.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.292
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.63
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.31

    Secondary: Inflammatory markers in sputum

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    End point title
    		 Inflammatory markers in sputum
    End point description
    Assay of induced sputum collections at Visits 1a, 2, 3a and 4 for the following markers: (including, but not limited to) TNFα, IL-6, IL-1β, RANTES, MCP-1 (exploratory non-GLP assays) LTB4 and IL-8 (validated assays). The endpoint was end of treatment data (mean of Visits 3a and 4).
    End point type
    Secondary
    End point timeframe
    End of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    26
    Units: pg/ml
    geometric mean (geometric coefficient of variation)
        TNFα
    30.75 ± 162.984
    28.48 ± 129.895
        IL-6
    36.7 ± 153.923
    20.26 ± 119.341
        IL-8
    16215.69 ± 122.519
    14310.01 ± 58.854
        IL-1β
    732.62 ± 179.177
    1037.34 ± 95.671
        LTB4
    951.76 ± 93.26
    808.64 ± 91.431
        RANTES
    6.26 ± 74.072
    4.41 ± 69.745
        MCP-1
    131.16 ± 98.78
    88.5 ± 65.083
    Statistical analysis title
    		 Ratio of AZD9668 over placebo in TNFα
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log transformed data. The table presents the results back transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.139
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.73
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.04
    Statistical analysis title
    		 Ratio of AZD9668 over placebo in IL-6
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.59
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.8
    Statistical analysis title
    		 Ratio of AZD9668 over placebo in IL-8
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log transformed data. The table presents the results back transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.238
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.08
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in IL-1β
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the resultsback-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.481
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.2
    Statistical analysis title
    		 Ratio of AZD9668 over placebo in LTB4
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.901
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.24
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in RANTES
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1
    Statistical analysis title
    		 Ratio of AZD9668 over placebo in MCP-1
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.129
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.02

    Secondary: Inflammatory markers in blood

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    End point title
    		 Inflammatory markers in blood
    End point description
    Assay of blood samples taken at Visits 2 and 4 for the following markers: (including, but not limited to) absolute and differential neutrophil cell count, serum amyloid-A and CRP (validated assays) and plasma TNFα, IL-6, IL-8 and IL-1β (exploratory non-GLP assays). The endpoint was end of treatment data (Visit 4).
    End point type
    Secondary
    End point timeframe
    End of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    26
    Units: pg/ml mg/L ng/mL
    geometric mean (geometric coefficient of variation)
        TNFα (pg/mL)
    7.92 ± 43.019
    7.34 ± 38.85
        IL-6 (pg/mL)
    3.83 ± 79.305
    5.02 ± 68.793
        IL-8 (pg/mL)
    6.84 ± 54.726
    7.83 ± 54.68
        IL-1β (pg/mL)
    1.35 ± 27.045
    1.32 ± 24.822
        CRP (mg/L)
    2.31 ± 200.436
    5.73 ± 156.44
        Amyloid A (ng/mL)
    6565.98 ± 356.623
    22609.16 ± 399.631
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in TNFα
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.223
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.02
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in IL-6
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.797
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.28
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in IL-8
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.833
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.3
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in IL-1β
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in CRP
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the resultsback-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.245
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    1.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 2.06
    Statistical analysis title
    		 Ratio of AZD9668 to placebo in Amyloid A
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the resultsback-transformed after the analysis on the original scale
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.278
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    1.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.98

    Secondary: plasma concentration data for AZD9668

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    End point title
    		 plasma concentration data for AZD9668 [1]
    End point description
    End point type
    Secondary
    End point timeframe
    Day1 and Day28
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Concentration of AZD9668 was not measured in the placebo group.
    End point values
    		 AZD9668
    Number of subjects analysed
    26
    Units: nM
    geometric mean (geometric coefficient of variation)
        Day 1 3-4 h
    500 ± 43.8
        Day 28 pre-dose
    189 ± 61.5
        Day28 3-4h
    723 ± 38.2
    No statistical analyses for this end point

    Secondary: AZD9668 Concentration in induced sputum supernatant

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    End point title
    		 AZD9668 Concentration in induced sputum supernatant [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 21-26 and Day28
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Concentration of AZD9668 was not measured in the placebo group.
    End point values
    		 AZD9668
    Number of subjects analysed
    26
    Units: nM
    geometric mean (geometric coefficient of variation)
        Day 21-26
    72.8 ± 106
        Day 28 Pre-dose
    63.4 ± 92.6
    No statistical analyses for this end point

    Secondary: Markers of tissue degradation in urine

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    End point title
    		 Markers of tissue degradation in urine
    End point description
    End of treatment is the data at Visit 4
    End point type
    Secondary
    End point timeframe
    end of treatment
    End point values
    		 Placebo AZD9668
    Number of subjects analysed
    29
    26
    Units: nmol/mmol
    geometric mean (geometric coefficient of variation)
        Desmosine (Free) Normalised by Creatinine
    2.22 ± 51.232
    1.4 ± 35.679
        Desmosine (Total) Normalised by Creatinine
    2.67 ± 104.344
    1.87 ± 44.619
    Statistical analysis title
    		 Ratio of AZD9668 over Placebo in Desmosine (Total)
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.93
    Statistical analysis title
    		 Ratio of AZD9668 over Placebo in Desmosine (free)
    Statistical analysis description
    Analysis of covariance includes treatment, country and baseline as covariates. The analysis is done on log-transformed data. The table presents the results back-transformed after the analysis on the original scale.
    Comparison groups
    Placebo v AZD9668
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.83

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From enrolment to 7 days after the end of treatment (visit 4).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    AZD9668
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 AZD9668 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    pulmonary exacerbation
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    pneumonia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         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: 0%
    Non-serious adverse events
    		 AZD9668 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 26 (46.15%)
    12 / 29 (41.38%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 26 (26.92%)
    5 / 29 (17.24%)
         occurrences all number
    10
    10
    General disorders and administration site conditions
    Fatique
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Non cardiac chest pain
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    4
    Pyrexia
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 29 (10.34%)
         occurrences all number
    2
    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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    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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