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    Clinical Trial Results:
    A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent Asthma

    Summary
    EudraCT number
    2008-007844-33
    Trial protocol
    DE   GB   BG  
    Global end of trial date
    03 Aug 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP199
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00873860
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Rene van de Merwe, Senior Director, Clinical Development, MedImmune, LLC., vandermerwer@medimmune.com
    Scientific contact
    Rene van de Merwe, Senior Director, Clinical Development, MedImmune, LLC., vandermerwer@medimmune.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
    03 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of 3 subcutaneous (SC) treatment regimens of CAT-354 versus placebo on asthma control at Study Day 92 in adults with uncontrolled, moderate-to-severe, persistent asthma.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jun 2009
    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
    Poland: 37
    Country: Number of subjects enrolled
    Romania: 77
    Country: Number of subjects enrolled
    Bulgaria: 52
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    United Kingdom: 7
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    194
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 357 participants were screened in this study, out of which 194 participants were enrolled and randomized.

    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, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo matched to CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Arm title
    CAT-354 150 mg
    Arm description
    CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
    Arm type
    Experimental

    Investigational medicinal product name
    CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CAT-354 150 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Arm title
    CAT-354 300 mg
    Arm description
    CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
    Arm type
    Experimental

    Investigational medicinal product name
    CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Arm title
    CAT-354 600 mg
    Arm description
    CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
    Arm type
    Experimental

    Investigational medicinal product name
    CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Number of subjects in period 1
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Started
    48
    47
    51
    48
    Treated
    47
    47
    51
    48
    Completed
    44
    47
    48
    47
    Not completed
    4
    0
    3
    1
         Adverse event, serious fatal
             1
             -
             -
             -
         Unspecified
             1
             -
             1
             -
         Consent withdrawn by subject
             1
             -
             2
             -
         Lost to follow-up
             1
             -
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 150 mg
    Reporting group description
    CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 300 mg
    Reporting group description
    CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 600 mg
    Reporting group description
    CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg Total
    Number of subjects
    48 47 51 48 194
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    48 47 51 48 194
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    47.2 ± 9.8 43.4 ± 11.1 48.7 ± 11 49.8 ± 10.4 -
    Gender, Male/Female
    Units: participants
        Female
    33 19 36 28 116
        Male
    15 28 15 20 78

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 150 mg
    Reporting group description
    CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 300 mg
    Reporting group description
    CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 600 mg
    Reporting group description
    CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Primary: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92

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    End point title
    Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
    End point description
    ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline), Day 92
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day 1 (n=46, 46, 50, 47)
    2.63 ± 0.51
    2.72 ± 0.58
    2.62 ± 0.5
    2.72 ± 0.76
        Change at Day 92 (n= 46, 46, 51, 47)
    -0.61 ± 0.9
    -0.73 ± 1.12
    -0.7 ± 0.93
    -0.86 ± 1.09
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.573 [1]
    Method
    ANOVA
    Confidence interval
    Notes
    [1] - Change at Day 92: p-value was based on analysis of variance (ANOVA).
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.64 [2]
    Method
    ANOVA
    Confidence interval
    Notes
    [2] - Change at Day 92: p-value was based on ANOVA.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.224 [3]
    Method
    ANOVA
    Confidence interval
    Notes
    [3] - Change at Day 92: p-value was based on ANOVA.

    Secondary: Time to First Observed Asthma Control

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    End point title
    Time to First Observed Asthma Control
    End point description
    Time to first asthma control defined as number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 92 and Day 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: days
    median (confidence interval 95%)
        Day 1 to 92
    25.5 (15 to 71)
    22 (15 to 43)
    15 (15 to 43)
    15 (15 to 36)
        Day 1 to 169
    25.5 (15 to 71)
    22 (15 to 43)
    15 (15 to 43)
    15 (15 to 36)
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4686 [4]
    Method
    Logrank
    Confidence interval
    Notes
    [4] - Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.317 [5]
    Method
    Logrank
    Confidence interval
    Notes
    [5] - Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1664 [6]
    Method
    Logrank
    Confidence interval
    Notes
    [6] - Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3234 [7]
    Method
    Logrank
    Confidence interval
    Notes
    [7] - Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3133 [8]
    Method
    Logrank
    Confidence interval
    Notes
    [8] - Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2108 [9]
    Method
    Logrank
    Confidence interval
    Notes
    [9] - Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.

    Secondary: Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169

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    End point title
    Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
    End point description
    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.Here, ''n'' signifies participants evaluable for specified category for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline), 15, 29, 43, 57, 71, 85, 92, 127 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: liters
    arithmetic mean (standard deviation)
        Day 1 (n=46,46,51,47)
    1.949 ± 0.479
    2.178 ± 0.661
    1.907 ± 0.586
    1.977 ± 0.646
        Change at Day 15 (n=44,46,50,46)
    0.019 ± 0.42
    0.122 ± 0.316
    0.116 ± 0.378
    0.134 ± 0.348
        Change at Day 29 (n=46,46,49,47)
    0.051 ± 0.424
    0.138 ± 0.315
    0.149 ± 0.303
    0.222 ± 0.354
        Change at Day 43 (n=45,44,47,47)
    0.125 ± 0.399
    0.131 ± 0.38
    0.164 ± 0.358
    0.147 ± 0.373
        Change at Day 57 (n=45,46,49,47)
    0.043 ± 0.436
    0.127 ± 0.339
    0.187 ± 0.349
    0.201 ± 0.344
        Change at Day 71 (n=45,45,49,47)
    0.047 ± 0.397
    0.158 ± 0.314
    0.179 ± 0.381
    0.19 ± 0.335
        Change at Day 85 (n=45,46,48,47)
    0.087 ± 0.397
    0.135 ± 0.342
    0.286 ± 0.393
    0.265 ± 0.473
        Change at Day 92 (n=42,44,49,44)
    0.063 ± 0.476
    0.158 ± 0.348
    0.211 ± 0.374
    0.262 ± 0.408
        Change at Day 127 (n=44,44,49,47)
    0.094 ± 0.489
    0.144 ± 0.263
    0.241 ± 0.381
    0.237 ± 0.285
        Change at Day 169 (n=42,42,47,47)
    0.101 ± 0.442
    0.204 ± 0.378
    0.211 ± 0.394
    0.236 ± 0.366
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169

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    End point title
    Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
    End point description
    The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day -7 to 1 (predose), Day 2 to 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: liters/minute
    arithmetic mean (standard deviation)
        Day -7 to 1 (n=46,46,51,47)
    282.63 ± 100.65
    351.06 ± 130.41
    291.54 ± 119.46
    325.23 ± 123.9
        Change in Day 2 to 8 (n=44,46,51,47)
    -5.77 ± 22.74
    1.91 ± 23.81
    -4.53 ± 19.02
    5.94 ± 29.93
        Change in Day 9 to 15 (n=45,46,51,47)
    -7.46 ± 29.68
    -4.1 ± 28.15
    -2.83 ± 24.4
    5.75 ± 42.34
        Change in Day 16 to 22 (n=45,46,51,47)
    -8.94 ± 35.72
    -6.53 ± 32.7
    -0.37 ± 33.85
    10.55 ± 51.26
        Change in Day 23 to 29 (n=44,46,51,47)
    -10.53 ± 40.06
    -6.61 ± 37.95
    -0.79 ± 36.94
    10.61 ± 52.64
        Change in Day 30 to 36 (n=45,46,51,47)
    -5.69 ± 44.69
    -5.69 ± 41.87
    -1.98 ± 36.06
    6.52 ± 50.15
        Change in Day 37 to 43 (n=44,46,50,47)
    -11.08 ± 41.52
    -2 ± 49.76
    -4.07 ± 39.8
    5.55 ± 54.28
        Change in Day 44 to 50 (n=44,46,50,47)
    -6.37 ± 41.5
    -9.02 ± 47.51
    -5.3 ± 36.57
    -0.84 ± 50.67
        Change in Day 51 to 57 (n=45,46,50,47)
    -7 ± 41.7
    -6.01 ± 47.36
    -4.85 ± 41.27
    -3.57 ± 52.84
        Change in Day 58 to 64 (n=45,46,50,46)
    -9.84 ± 38.73
    -2.83 ± 47.42
    -1.42 ± 41.9
    -0.73 ± 55.98
        Change in Day 65 to 71 (n=45,46,50,46)
    -11.81 ± 43.87
    -3.98 ± 47.2
    -0.92 ± 49.95
    -1.82 ± 49.79
        Change in Day 72 to 78 (n=44,45,50,47)
    -3.72 ± 44.07
    -3.42 ± 53.55
    2.54 ± 45.58
    1.78 ± 49.45
        Change in Day 79 to 85 (n=45,45,50,46)
    -10.83 ± 43.99
    -6.67 ± 54.49
    -0.35 ± 40.29
    5.3 ± 60.62
        Change in Day 86 to 92 (n=45,46,50,47)
    -3.26 ± 47.36
    -6.66 ± 51.23
    5.04 ± 40.52
    0.31 ± 62.86
        Change in Day 93 to 99 (n=45,46,50,47)
    -2.52 ± 47.94
    -4.99 ± 49.91
    5.16 ± 40.99
    7.81 ± 58.29
        Change in Day 100 to 106 (n=44,46,49,47)
    -9.6 ± 55.47
    -7.33 ± 52.64
    1.93 ± 43.08
    2 ± 62.18
        Change in Day 107 to 113 (n=44,45,48,47)
    -7.53 ± 56.29
    -11.29 ± 57.33
    0.53 ± 45.6
    0.39 ± 61.52
        Change in Day 114 to 120 (n=42,45,47,47)
    -2.19 ± 61.74
    -8.97 ± 55.61
    4.85 ± 39.54
    -3.03 ± 59.68
        Change in Day 121 to 127 (n=42,46,46,46)
    -3.58 ± 65.64
    -8.99 ± 64.6
    3.61 ± 46.18
    -4.21 ± 57.88
        Change in Day 128 to 134 (n=42,45,45,47)
    -4.39 ± 61.22
    -14.81 ± 61.39
    4.62 ± 44.65
    -2.64 ± 56.87
        Change in Day 135 to 141 (n=40,45,47,47)
    -0.26 ± 58.83
    -17.03 ± 58.99
    1.11 ± 44.36
    -6.03 ± 63.13
        Change in Day 142 to 148 (n=40,45,47,47)
    5.16 ± 66.54
    -11.63 ± 61.02
    -2.69 ± 51.65
    -9.65 ± 65.62
        Change in Day 149 to 155 (n=40,45,46,47)
    0.43 ± 60.53
    -9.56 ± 60.13
    -7.65 ± 47.44
    -11.07 ± 62.16
        Change in Day 156 to 162 (n=40,45,46,46)
    -1.38 ± 65.53
    -11.6 ± 62.14
    -10.05 ± 43.11
    -10.68 ± 66.86
        Change in Day 163 to 169 (n=37,41,42,40)
    -0.36 ± 58.66
    -5.68 ± 60.69
    -4.71 ± 49.29
    -3.23 ± 66.84
    No statistical analyses for this end point

    Secondary: Number of Puffs of Rescue Beta-2 Agonist Per Week

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    End point title
    Number of Puffs of Rescue Beta-2 Agonist Per Week
    End point description
    Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day -7 to 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: puffs per week
    arithmetic mean (standard deviation)
        Day -7 to 1 (n=46,46, 51,47)
    2.58 ± 1.7
    2.84 ± 2.03
    2.04 ± 1.51
    2.62 ± 1.96
        Day 2 to 8 (n=45,46, 51,47)
    2.5 ± 1.8
    2.4 ± 2
    1.9 ± 1.5
    2.3 ± 2
        Day 9 to 15 (n=46,46, 51,47)
    2.4 ± 1.8
    2.5 ± 2.3
    1.9 ± 1.5
    2.2 ± 2
        Day 16 to 22 (n=46,46, 51,47)
    2.6 ± 1.9
    2.2 ± 2
    1.9 ± 1.7
    2.3 ± 2.2
        Day 23 to 29 (n=45,46, 51,47)
    2.7 ± 2.1
    2.2 ± 2
    2 ± 1.9
    2.2 ± 2.1
        Day 30 to 36 (n=46,46, 51,47)
    2.5 ± 2
    2.1 ± 2.2
    1.9 ± 2
    2 ± 1.9
        Day 37 to 43 (n=45,46, 50,47)
    2.4 ± 2
    2.1 ± 2.2
    1.9 ± 2
    2 ± 2
        Day 44 to 50 (n=45,46, 50,47)
    2.5 ± 2
    1.9 ± 2.2
    1.7 ± 2
    2 ± 2
        Day 51 to 57 (n=45,46, 50,47)
    2.5 ± 2.1
    2 ± 2
    1.8 ± 1.9
    2 ± 2.1
        Day 58 to 64 (n=46,46, 49,46)
    2.5 ± 2.2
    1.9 ± 2
    1.9 ± 2
    1.8 ± 2
        Day 65 to 71 (n=46,46, 50,47)
    2.7 ± 2.3
    2 ± 2
    1.8 ± 2
    2 ± 1.9
        Day 72 to 78 (n=45,45, 50,46)
    2.5 ± 2.2
    2 ± 2
    1.8 ± 2.1
    1.9 ± 1.8
        Day 79 to 85 (n=46,46, 50,46)
    2.6 ± 2.3
    2.1 ± 2.1
    1.9 ± 2
    1.8 ± 1.8
        Day 86 to 92 (n=46,46, 50,47)
    2.5 ± 2.3
    2 ± 2.1
    1.8 ± 2
    1.7 ± 1.7
        Day 93 to 99 (n=46,46, 50,47)
    2.4 ± 2.2
    1.7 ± 2
    1.8 ± 2.1
    1.6 ± 1.8
        Day 100 to 106 (n=45,46, 49,47)
    2.3 ± 2.1
    1.9 ± 2.2
    1.7 ± 2.2
    1.8 ± 1.8
        Day 107 to 113 (n=45,45, 48,47)
    2.4 ± 2.1
    1.9 ± 2.2
    1.7 ± 1.9
    1.7 ± 1.6
        Day 114 to 120 (n=43,45, 47,47)
    2.3 ± 2
    1.9 ± 2.1
    1.7 ± 1.9
    1.7 ± 1.7
        Day 121 to 127 (n=43,46, 46,47)
    2.2 ± 1.9
    1.9 ± 2.2
    1.8 ± 2
    1.6 ± 1.6
        Day 128 to 134 (n=44,45, 47,47)
    2.2 ± 2.1
    1.8 ± 2
    1.6 ± 1.9
    1.6 ± 1.7
        Day 135 to 141 (n=42,45, 47,47)
    2.2 ± 2
    1.9 ± 1.9
    1.7 ± 2
    1.7 ± 1.8
        Day 142 to 148 (n=42,45, 47,47)
    2.3 ± 2
    1.9 ± 2.1
    1.8 ± 2
    1.8 ± 1.8
        Day 149 to 155 (n=42,45, 46,47)
    2.4 ± 2.2
    1.9 ± 2.1
    1.8 ± 2
    1.8 ± 1.8
        Day 156 to 162 (n=42,45, 46,46)
    2.3 ± 2.1
    1.9 ± 2.1
    1.7 ± 2.2
    2 ± 2
        Day 163 to 169 (n=39,41,42,40)
    2.7 ± 2.6
    1.9 ± 2.1
    1.6 ± 1.8
    1.7 ± 1.9
    No statistical analyses for this end point

    Secondary: Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores

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    End point title
    Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
    End point description
    AQLQ[S]: a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 92, 127 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Overall : Day 1 (n=41,41,44,39)
    4.22 ± 0.83
    3.96 ± 0.89
    4.12 ± 0.8
    4.11 ± 0.94
        Overall: Day 29 (n=43,41,44,40)
    4.39 ± 1.04
    4.39 ± 1.01
    4.47 ± 0.97
    4.6 ± 0.91
        Overall: Day 57 (n=44,40,43,45)
    4.57 ± 1.03
    4.56 ± 1.15
    4.47 ± 1.05
    4.73 ± 0.96
        Overall: Day 92 (n=40,42,40,38)
    4.7 ± 1.16
    4.88 ± 1.31
    4.74 ± 1.15
    4.87 ± 0.99
        Overall: Day 127 (n=41,42,44,42)
    4.69 ± 1.22
    4.76 ± 1.29
    4.64 ± 1.11
    4.85 ± 1.13
        Overall: Day 169 (n=41,44,45,44)
    4.72 ± 1.29
    4.73 ± 1.26
    4.61 ± 1.27
    4.76 ± 1.13
        Symptom: Day 1 (n=41,41,44,39)
    4.15 ± 0.88
    3.89 ± 0.84
    4.11 ± 0.71
    4.08 ± 1.06
        Symptom: Day 29 (n=43,41,44,40)
    4.32 ± 1.08
    4.44 ± 1.07
    4.48 ± 0.94
    4.56 ± 1.01
        Symptom: Day 57 (n=44,40,43,45)
    4.61 ± 1.02
    4.68 ± 1.23
    4.49 ± 1.05
    4.73 ± 1.05
        Symptom: Day 92 (n=40,42,40,38)
    4.77 ± 1.17
    4.88 ± 1.4
    4.78 ± 1.17
    4.92 ± 1.01
        Symptom: Day 127 (n=41,42,44,42)
    4.74 ± 1.33
    4.79 ± 1.31
    4.69 ± 1.09
    4.95 ± 1.31
        Symptom: Day 169 (n=41,44,45,44)
    4.82 ± 1.3
    4.76 ± 1.29
    4.63 ± 1.26
    4.77 ± 1.31
        Activity Limitation: Day 1 (n=41,41,44,39)
    4.38 ± 0.83
    4.07 ± 0.88
    4.13 ± 0.97
    4.15 ± 0.91
        Activity Limitation: Day 29 (n=43,41,44,40)
    4.47 ± 1
    4.37 ± 1.07
    4.42 ± 1.08
    4.59 ± 0.92
        Activity Limitation: Day 57 (n=44,40,43,45)
    4.57 ± 1.03
    4.42 ± 1.09
    4.41 ± 1.14
    4.74 ± 0.99
        Activity Limitation: Day 92 (n=40,42,40,38)
    4.68 ± 1.19
    4.89 ± 1.29
    4.73 ± 1.15
    4.91 ± 1.04
        Activity Limitation: Day 127 (n=41,42,44,42)
    4.64 ± 1.2
    4.77 ± 1.32
    4.62 ± 1.13
    4.66 ± 1.08
        Activity Limitation: Day 169 (n=41,44,45,44)
    4.68 ± 1.28
    4.76 ± 1.26
    4.54 ± 1.31
    4.7 ± 1.14
        Emotional Function: Day 1 (n=41,41,44,39)
    4.3 ± 1.08
    4.2 ± 1.18
    4.45 ± 1.1
    4.29 ± 1.24
        Emotional Function: Day 29 (n=43,41,44,40)
    4.64 ± 1.27
    4.82 ± 1.17
    4.82 ± 1.22
    4.88 ± 1.17
        Emotional Function: Day 57 (n=44,40,43,45)
    4.85 ± 1.36
    4.98 ± 1.42
    4.87 ± 1.24
    4.99 ± 1.13
        Emotional Function: Day 92 (n=40,42,40,38)
    5 ± 1.31
    5.24 ± 1.33
    4.99 ± 1.45
    4.98 ± 1.02
        Emotional Function: Day 127 (n=41,42,44,42)
    5.08 ± 1.4
    5.06 ± 1.48
    4.98 ± 1.4
    5.28 ± 1.29
        Emotional Function: Day 169 (n=41,44,45,44)
    5.05 ± 1.56
    5 ± 1.5
    5.06 ± 1.39
    5.13 ± 1.28
        Environment stimuli: Day 1 (n=41,41,44,39)
    3.88 ± 1.28
    3.55 ± 1.43
    3.7 ± 1.11
    3.85 ± 1.1
        Environment stimuli: Day 29 (n=43,41,44,40)
    4.06 ± 1.26
    3.75 ± 1.48
    4.13 ± 1.41
    4.4 ± 1.2
        Environment stimuli: Day 57 (n=44,40,43,45)
    4.07 ± 1.34
    4.04 ± 1.36
    4.09 ± 1.43
    4.37 ± 1.49
        Environment stimuli: Day 92 (n=40,42,40,38)
    4.16 ± 1.56
    4.44 ± 1.63
    4.31 ± 1.43
    4.47 ± 1.47
        Environment stimuli: Day 127 (n=41,42,44,42)
    4.18 ± 1.58
    4.3 ± 1.57
    4.15 ± 1.56
    4.51 ± 1.64
        Environment stimuli: Day 169 (n=41,44,45,44)
    4.13 ± 1.54
    4.26 ± 1.5
    4.18 ± 1.76
    4.45 ± 1.51
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169

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    End point title
    Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
    End point description
    AQLQ[S]: a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score calculated as mean response to all questions. The 4 domain scores were means of the responses to questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing considered as baseline. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies participants who were evaluable at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 92, 127 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Overall: Day 29 (n=34,35,37,31)
    0.32 ± 0.65
    0.38 ± 0.64
    0.39 ± 0.88
    0.66 ± 0.76
        Overall: Day 57 (n=33,33,35,34)
    0.45 ± 0.77
    0.7 ± 0.99
    0.38 ± 0.95
    0.77 ± 1.04
        Overall: Day 92 (n=31,34,35,27)
    0.63 ± 0.88
    0.94 ± 1.21
    0.52 ± 1.07
    1.05 ± 1.25
        Overall: Day 127 (n=32,36,34,31)
    0.71 ± 0.85
    0.78 ± 1.21
    0.49 ± 1.14
    1.05 ± 1.15
        Overall: Day 169 (n=31,37,37,34)
    0.64 ± 1.05
    0.78 ± 1.19
    0.56 ± 1.09
    0.75 ± 1.26
        Symptom: Day 29 (n=34,35,37,31)
    0.31 ± 0.81
    0.49 ± 0.83
    0.43 ± 0.83
    0.62 ± 0.8
        Symptom: Day 57 (n=33,33,35,34)
    0.52 ± 0.86
    0.87 ± 1.1
    0.44 ± 0.85
    0.81 ± 1.11
        Symptom: Day 92 (n=31,34,35,27)
    0.76 ± 1
    1 ± 1.32
    0.61 ± 1.11
    1.14 ± 1.39
        Symptom: Day 127 (n=32,36,34,31)
    0.85 ± 1.03
    0.87 ± 1.24
    0.56 ± 1.14
    1.24 ± 1.23
        Symptom: Day 169 (n=31,37,37,34)
    0.8 ± 1.06
    0.86 ± 1.22
    0.62 ± 1.17
    0.77 ± 1.34
        Activity Limitation: Day 29 (n=34,35,37,31)
    0.21 ± 0.64
    0.25 ± 0.69
    0.32 ± 0.96
    0.57 ± 0.9
        Activity Limitation: Day 57 (n=33,33,35,34)
    0.28 ± 0.79
    0.44 ± 0.89
    0.3 ± 1.08
    0.71 ± 1.07
        Activity Limitation: Day 92 (n=31,34,35,27)
    0.42 ± 0.81
    0.8 ± 1.12
    0.51 ± 1.12
    1.04 ± 1.26
        Activity Limitation: Day 127 (n=32,36,34,31)
    0.43 ± 0.77
    0.65 ± 1.2
    0.45 ± 1.14
    0.72 ± 1.28
        Activity Limitation: Day 169 (n=31,37,37,34)
    0.38 ± 1.09
    0.68 ± 1.16
    0.44 ± 1.09
    0.65 ± 1.37
        Emotional Function: Day 29 (n=34,35,37,31)
    0.5 ± 0.93
    0.57 ± 0.76
    0.36 ± 1.04
    0.86 ± 0.97
        Emotional Function: Day 57 (n=33,33,35,34)
    0.69 ± 1.15
    0.95 ± 1.16
    0.42 ± 1.15
    0.86 ± 1.21
        Emotional Function: Day 92 (n=31,34,35,27)
    0.87 ± 1.25
    1.06 ± 1.25
    0.43 ± 1.26
    0.93 ± 1.39
        Emotional Function: Day 127 (n=32,36,34,31)
    1.02 ± 1.2
    0.87 ± 1.38
    0.41 ± 1.32
    1.32 ± 1.42
        Emotional Function: Day 169 (n=31,37,37,34)
    0.88 ± 1.42
    0.88 ± 1.36
    0.63 ± 1.2
    0.95 ± 1.4
        Environmental Stimuli: Day 29 (n=34,35,37,31)
    0.4 ± 0.85
    0.16 ± 0.78
    0.47 ± 1.18
    0.76 ± 0.8
        Environmental Stimuli: Day 57 (n=33,33,35,34)
    0.36 ± 0.86
    0.58 ± 1.39
    0.38 ± 1.27
    0.65 ± 1.4
        Environmental Stimuli: Day 92 (n=31,34,35,27)
    0.54 ± 0.94
    0.97 ± 1.68
    0.42 ± 1.17
    0.94 ± 1.28
        Environmental Stimuli: Day 127 (n=32,36,34,31)
    0.64 ± 1.11
    0.74 ± 1.68
    0.48 ± 1.45
    1.02 ± 1.22
        Environmental Stimuli: Day 169 (n=31,37,37,34)
    0.52 ± 1.17
    0.75 ± 1.55
    0.58 ± 1.3
    0.74 ± 1.39
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC)

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    End point title
    Patient Global Impression of Change (PGIC)
    End point description
    Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better). Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day 92 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day 92 (n=40,42,40,38)
    5.1 ± 1.1
    5.3 ± 1.1
    5.3 ± 1
    5.2 ± 1.2
        Day 169 (n=42,44,45,44)
    5.1 ± 1.1
    5.3 ± 1.1
    5 ± 1
    5.1 ± 1.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 but Less Than 1.5

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    End point title
    Percentage of Participants with Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 but Less Than 1.5
    End point description
    Percentage of participants with mean ACQ score less than or equal to (<=) 0.75 or mean ACQ score greater than (>) 0.75 and less than (<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (>) 0.75 but less than (<) 1.5 indicated partly controlled asthma. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
    End point type
    Secondary
    End point timeframe
    Day 92 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: percentage of participants
    number (not applicable)
        ACQ score<=0.75: Day 92
    13
    19.6
    11.8
    17
        ACQ score>0.75 and <1.5: Day 92
    15.2
    13
    15.7
    19.1
        ACQ score<=0.75: Day 169
    13
    19.6
    13.7
    19.1
        ACQ score>0.75 and <1.5: Day 169
    21.7
    10.9
    17.6
    19.1
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v CAT-354 150 mg v CAT-354 300 mg v CAT-354 600 mg
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.592 [10]
    Method
    Fisher exact
    Confidence interval
    Notes
    [10] - ACQ score <=0.75, Day 169: Fisher exact test was used to compare all arms.
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v CAT-354 150 mg v CAT-354 300 mg v CAT-354 600 mg
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.934 [11]
    Method
    Fisher exact
    Confidence interval
    Notes
    [11] - ACQ score <=0.75, Day 92: Fisher exact test was used to compare all arms.

    Secondary: Serum Concentration for CAT-354

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    End point title
    Serum Concentration for CAT-354 [12]
    End point description
    Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169
    Notes
    [12] - 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: No inferential statistical analysis was planned for this end-point
    End point values
    CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    47
    51
    48
    Units: microgram per milliliter (mcg/mL)
    arithmetic mean (standard deviation)
        Day 15 (n=46,48,48)
    14.5 ± 5.57
    27.8 ± 10.3
    56.4 ± 16
        Day 29 (n=45,51,47)
    20.8 ± 7.2
    40.2 ± 15
    81.9 ± 23.5
        Day 43 (n=46,50,47)
    26.9 ± 12.7
    51 ± 16
    98.5 ± 33.4
        Day 57 (n=46,48,46)
    28.4 ± 11.3
    58.8 ± 20.2
    108 ± 35.8
        Day 71 (n=46,49,47)
    29.3 ± 11.9
    61 ± 21.4
    112 ± 41.2
        Day 85 (n=45,49,47)
    31.1 ± 12.5
    62 ± 23.8
    120 ± 44.5
        Day 88 (n=46,48,45)
    43.4 ± 15.8
    85.7 ± 32.7
    157 ± 56.5
        Day 92 (n=45,46,45)
    42 ± 16.3
    86.8 ± 33.1
    156 ± 46.6
        Day 99 (n=46,50,46)
    31.3 ± 13
    69.3 ± 27.2
    125 ± 41.9
        Day 127 (n=47,48,47)
    11.5 ± 6.02
    22.9 ± 12
    43.7 ± 20.5
        Day 169 (n=47,48,46)
    2.94 ± 2.23
    5.87 ± 3.69
    10.1 ± 6.71
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-Drug Antibodies to CAT-354 at any Visit

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    End point title
    Number of Participants With Anti-Drug Antibodies to CAT-354 at any Visit
    End point description
    Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Day 1, 92 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    47
    47
    49
    47
    Units: participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Positive Serum Antibodies to CAT-354 at any Visit

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    End point title
    Percentage of Participants With Positive Serum Antibodies to CAT-354 at any Visit
    End point description
    Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Day 1, 92 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    47
    47
    49
    47
    Units: percentage of participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state. Safety population included all participants who received any dose of the investigational product.
    End point type
    Secondary
    End point timeframe
    Day 1 to 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    47
    47
    51
    48
    Units: participants
        TEAEs
    17
    20
    25
    25
        TESAEs
    3
    2
    0
    1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With at least 1 Moderate or Severe Exacerbation

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    End point title
    Percentage of Participants With at least 1 Moderate or Severe Exacerbation
    End point description
    Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons.
    End point type
    Secondary
    End point timeframe
    Day 92 and 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: Percentage of Participants
    number (not applicable)
        Day 92
    4.3
    2.2
    2
    4.3
        Day 169
    4.3
    4.3
    3.9
    6.4
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [13]
    Method
    Fisher exact
    Confidence interval
    Notes
    [13] - Day 92: Fisher exact test was used for the analysis.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6022 [14]
    Method
    Fisher exact
    Confidence interval
    Notes
    [14] - Day 92: Fisher exact test was used for the analysis.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [15]
    Method
    Fisher exact
    Confidence interval
    Notes
    [15] - Day 92: Fisher exact test was used for the analysis.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [16]
    Method
    Fisher exact
    Confidence interval
    Notes
    [16] - Day 169: Fisher exact test was used for the analysis.
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [17]
    Method
    Fisher exact
    Confidence interval
    Notes
    [17] - Day 169: Fisher exact test was used for the analysis.
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [18]
    Method
    Fisher exact
    Confidence interval
    Notes
    [18] - Day 169: Fisher exact test was used for the analysis.

    Secondary: Moderate or Severe Asthma Exacerbations per Person per Annum

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    End point title
    Moderate or Severe Asthma Exacerbations per Person per Annum
    End point description
    Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days*365 days, where X = 92 or 169). Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 92 and Day 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: asthma exacerbations/person/annum
    arithmetic mean (standard error)
        Day 1 to 92
    0.26 ± 0.19
    0.09 ± 0.09
    0.08 ± 0.08
    0.25 ± 0.19
        Day 1 to 169
    0.23 ± 0.19
    0.14 ± 0.1
    0.08 ± 0.06
    0.19 ± 0.11
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.551 [19]
    Method
    Van Elteren Test
    Confidence interval
    Notes
    [19] - Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.492 [20]
    Method
    Van Elteren Test
    Confidence interval
    Notes
    [20] - Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.983 [21]
    Method
    Van Elteren Test
    Confidence interval
    Notes
    [21] - Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.991 [22]
    Method
    Van Elteren Test
    Confidence interval
    Notes
    [22] - Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9 [23]
    Method
    Van Elteren Test
    Confidence interval
    Notes
    [23] - Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.673 [24]
    Method
    Van Elteren Test
    Confidence interval
    Notes
    [24] - Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.

    Secondary: Time to First Moderate or Severe Asthma Exacerbation

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    End point title
    Time to First Moderate or Severe Asthma Exacerbation
    End point description
    Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 92 and Day 169
    End point values
    Placebo CAT-354 150 mg CAT-354 300 mg CAT-354 600 mg
    Number of subjects analysed
    46
    46
    51
    47
    Units: days
    arithmetic mean (standard error)
        Day 1 to 92
    89.67 ± 1.56
    90.43 ± 1.32
    88.16 ± 2.12
    89.94 ± 1.36
        Day 1 to 169
    162.24 ± 3.79
    163.5 ± 3.24
    158.29 ± 4.41
    161.21 ± 3.71
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.546 [25]
    Method
    Logrank
    Confidence interval
    Notes
    [25] - Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.534 [26]
    Method
    Logrank
    Confidence interval
    Notes
    [26] - Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.847 [27]
    Method
    Logrank
    Confidence interval
    Notes
    [27] - Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo v CAT-354 150 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.987 [28]
    Method
    Logrank
    Confidence interval
    Notes
    [28] - Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo v CAT-354 300 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.992 [29]
    Method
    Logrank
    Confidence interval
    Notes
    [29] - Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Placebo v CAT-354 600 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.688 [30]
    Method
    Logrank
    Confidence interval
    Notes
    [30] - Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to 169
    Adverse event reporting additional description
    Safety population included all participants who received any dose of the investigational product.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 600 mg
    Reporting group description
    CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 300 mg
    Reporting group description
    CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Reporting group title
    CAT-354 150 mg
    Reporting group description
    CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

    Serious adverse events
    Placebo CAT-354 600 mg CAT-354 300 mg CAT-354 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    2 / 47 (4.26%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Somatoform disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Post cholecystectomy syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo CAT-354 600 mg CAT-354 300 mg CAT-354 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 47 (36.17%)
    25 / 48 (52.08%)
    25 / 51 (49.02%)
    19 / 47 (40.43%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    1
    1
    Hypertensive crisis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Labile hypertension
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 48 (6.25%)
    2 / 51 (3.92%)
    1 / 47 (2.13%)
         occurrences all number
    2
    4
    2
    1
    Infusion site induration
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    7
    3
    1
    0
    Injection site inflammation
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injection site induration
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
    2 / 47 (4.26%)
         occurrences all number
    0
    7
    8
    3
    Injection site pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    1
    1
    Injection site reaction
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site rash
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Menopausal disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Muscle rupture
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    Blood bilirubin
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Blood chloride increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    2 / 47 (4.26%)
         occurrences all number
    3
    1
    1
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
    3 / 47 (6.38%)
         occurrences all number
    3
    2
    2
    3
    Platelet count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reticulocyte count decreased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 47 (6.38%)
    6 / 48 (12.50%)
    5 / 51 (9.80%)
    5 / 47 (10.64%)
         occurrences all number
    6
    9
    6
    9
    Dyspnoea
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Productive cough
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    1 / 47 (2.13%)
         occurrences all number
    1
    2
    1
    4
    Rhinorrhoea
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 48 (6.25%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    3
    0
    1
    Leukopenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Monocytopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Monocytosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    2 / 47 (4.26%)
         occurrences all number
    1
    0
    1
    2
    Headache
         subjects affected / exposed
    2 / 47 (4.26%)
    6 / 48 (12.50%)
    1 / 51 (1.96%)
    6 / 47 (12.77%)
         occurrences all number
    3
    7
    1
    8
    Hypoaesthesia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lethargy
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    5
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Keratitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 47 (0.00%)
    5 / 48 (10.42%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nausea
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Crystalluria
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 48 (6.25%)
    1 / 51 (1.96%)
    1 / 47 (2.13%)
         occurrences all number
    0
    3
    1
    1
    Leukocyturia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nitrituria
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract inflammation
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Biliary dyskinesia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Muscle tightness
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    2 / 47 (4.26%)
         occurrences all number
    0
    1
    1
    2
    Pain in extremity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    1
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 47 (0.00%)
    4 / 48 (8.33%)
    2 / 51 (3.92%)
    2 / 47 (4.26%)
         occurrences all number
    0
    4
    2
    2
    Acute tonsillitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    2 / 47 (4.26%)
         occurrences all number
    3
    0
    1
    2
    Escherichia infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    H1n1 influenza
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
    0 / 47 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Laryngitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 48 (8.33%)
    3 / 51 (5.88%)
    3 / 47 (6.38%)
         occurrences all number
    4
    5
    4
    5
    Otitis media acute
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
    2 / 47 (4.26%)
         occurrences all number
    0
    1
    2
    2
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
    2 / 47 (4.26%)
         occurrences all number
    0
    1
    2
    3
    Tonsillitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
    3 / 47 (6.38%)
         occurrences all number
    0
    2
    1
    3
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2009
    - Modified the description of the gene and protein expression analyses to be performed as part of the exploratory analyses. - The upper age limit for participants in the study was increased to 65 years from 55 years - The inclusion criteria was modified: 1. To place an upper limit for predicted prebronchodilator FEV1 value of less than or equal to (<=) ) 80% of individual predicted value at Visits 1 and 3. 2. Provide clarification to ensure that only participants with uncontrolled asthma. 3. Clarified that participants should have an ACQ score >= 1.5 at Visits 1 and 3. 4. Clarified for the requirement for a chest x-ray from the previous 12 months that had no findings suggestive of acute or chronic respiratory pathology other than asthma. - Exclusion criteria was amended: 1. For the modification to exclude participants with a history of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to screening rather than 1 month prior to randomization as previously stated. 2. To change from a history of primary immunodeficiency to a history of any known immunodeficiency disorder. 3. Addition of positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or participant’s verbal report, A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or participant’s verbal report. - Protocol was revised to specify that the SC injections of investigational product were to be administered into the SC tissue of the anterior thigh rather than the triceps muscle as previously written. - Gamma-glutamyl transferase was added to the serum chemistry panel. -Definition of asthma exacerbation and resolution of asthma exacerbation was modified. - Text stating that acute exacerbations were to be reported separately was been deleted from the protocol.
    18 Nov 2009
    Modified the description of the gene and protein expression analyses to be performed as part of the exploratory analyses. - The inclusion criteria was modified: 1. To remove the upper limit on the prebronchodilator FEV1 value of greater than or equal to (>=) 40 % and <= 80% of individual predicted value at Visits 1 and 3. 2. To increase the upper limit of body mass index (BMI) 35 to 40 kilogram per meter square (kg/m^2). 3. The use of a condom by a male sexual partner of a female subject of childbearing potential was added to the list of acceptable methods of contraception. - Additional criteria for allowing one repeat screening visit was added to the protocol. - The requirements to withhold agents prior to spirometry were clarified to be consistent with the recommendations of the American Thoracic Society/European Respiratory Society (ATS/ERS) Task Force. - The text describing visits for participants who prematurely discontinue the study was clarified. - The language describing blinding and the planned Stage 1 analysis was clarified to make it clear that group level unblinded data from the Stage 1 analysis would not be shared outside the sponsor.

    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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