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    Clinical Trial Results:
    A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of CNTO 6785 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

    Summary
    EudraCT number
    		 2012-003607-36
    Trial protocol
    		 CZ   DE   HU  
    Global end of trial date
    28 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    08 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO6785OPD2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01966549
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    JanssenCilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, JanssenCilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, JanssenCilag International NV, ClinicalTrialsEU@its.jnj.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
    28 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess the efficacy of CNTO 6785 compared with placebo in subjects with symptomatic Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade II and GOLD Grade III COPD.
    Protection of trial subjects
    To protect the subjects in the study, a series of risk management actions were considered, excluding subjects with potential risks entering into the study, designed the discontinuation criteria during the study, applying for the comprehensive medical monitoring of clinical data on an ongoing basis and an independent Data Monitoring Committee to review unblinded data during the study to monitor patient safety and provide recommendation to the study implementation when identify significant safety signals. Safety monitoring also include assessing adverse Events, brief physical examinations, vital signs measurements, electrocardiogram (ECG) measurements, signs and symptoms of active tuberculosis (TB), laboratory assessments including chemistry, hematology and urinalysis during the study.
    Background therapy
    		 Subjects received Inhalation of long acting bronchodilators.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 53
    Country: Number of subjects enrolled
    Germany: 55
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 13
    Country: Number of subjects enrolled
    Malaysia: 9
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Taiwan: 2
    Worldwide total number of subjects
    187
    EEA total number of subjects
    144
    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)
    116
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 187 male and female subjects with moderate to severe COPD subjects despite inhaled long acting bronchodilators with or without inhaled corticosteroids were enrolled and and randomized equally to the placebo and CNTO 6785 group.

    Pre-assignment
    Screening details
    		 The study consisted of Screening phase (Week -3 to immediately prior to randomization at Study Visit 3), Treatment phase (at Study Visit 3 through Study Visit 8 at Week 12) and follow-up phase (after Study Visit 8 through Week 24). Prior to enrollment, subjects were screened to assess their eligibility for participation in the study.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received intravenous (IV) infusion of placebo (for not less than 30 minutes in duration) at Week 0, 2, 4, 8 and 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo IV infusion at Week 0, 2, 4, 8 and 12.

    Arm title
    		 CNTO 6785
    Arm description
    		 Subjects received IV infusion (for not less than 30 minutes in duration) of CNTO 6785 6 milligram per kilogram (mg/kg) at Week 0, 2, 4, 8 and 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO 6785
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received CNTO 6785 6 mg/kg IV infusion at Week 0, 2, 4, 8 and 12.

    Number of subjects in period 1
    		Placebo CNTO 6785
    Started
    94
    93
    Completed
    86
    81
    Not completed
    8
    12
         Consent withdrawn by subject
    3
    4
         Adverse event, non-fatal
    1
    4
         COPD Exacerbation
    -
    3
         Other
    -
    1
         Adverse event, serious non-fatal
    3
    -
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo (for not less than 30 minutes in duration) at Week 0, 2, 4, 8 and 12.

    Reporting group title
    CNTO 6785
    Reporting group description
    		 Subjects received IV infusion (for not less than 30 minutes in duration) of CNTO 6785 6 milligram per kilogram (mg/kg) at Week 0, 2, 4, 8 and 12.

    Reporting group values
    		 Placebo CNTO 6785 Total
    Number of subjects
    		 94 93 187
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 59 57 116
        From 65 to 84 years
    		 35 36 71
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.4 ± 7.22 62 ± 6.44 -
    Title for Gender
    Units: subjects
        Female
    		 29 32 61
        Male
    		 65 61 126

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo (for not less than 30 minutes in duration) at Week 0, 2, 4, 8 and 12.

    Reporting group title
    CNTO 6785
    Reporting group description
    		 Subjects received IV infusion (for not less than 30 minutes in duration) of CNTO 6785 6 milligram per kilogram (mg/kg) at Week 0, 2, 4, 8 and 12.

    Primary: Change From Baseline in Prebronchodilator Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 16

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    End point title
    		 Change From Baseline in Prebronchodilator Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 16
    End point description
    FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function. Modified intent-to-treat (mITT) analysis set included subjects who received at least 1 or partial dose of study agent and had at least 1 post-treatment efficacy measurement.
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo CNTO 6785
    Number of subjects analysed
    93 [1]
    92 [2]
    Units: percentage
    arithmetic mean (standard deviation)
        Baseline
    50.07 ± 10.663
    51.92 ± 10.297
        Change at Week 16
    -0.56 ± 6.363
    -1.12 ± 6.23
    Notes
    [1] - Here "N" signifies number of subjects analysed for this endpoint.
    [2] - Here "N" signifies number of subjects analysed for this endpoint.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    CNTO 6785 v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.599
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.03
         upper limit
    		 1.05

    Secondary: Change From Baseline in Postbronchodilator Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 16

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    End point title
    		 Change From Baseline in Postbronchodilator Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 16
    End point description
    FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function. mITT analysis set included subjects who received at least 1 or partial dose of study agent and had at least 1 post-treatment efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and WeeK 16
    End point values
    		 Placebo CNTO 6785
    Number of subjects analysed
    93 [3]
    92 [4]
    Units: percentage
    arithmetic mean (standard deviation)
        Baseline
    53.87 ± 10.113
    56.18 ± 9.306
        Change at Week 16
    -0.82 ± 6.37
    -1.82 ± 6.372
    Notes
    [3] - Here "N" signifies number of subjects analysed for this endpoint.
    [4] - Here "N" signifies number of subjects analysed for this endpoint.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    CNTO 6785 v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.286
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.57
         upper limit
    		 0.551

    Secondary: Change from Baseline in Use of Rescue Medication at Week 16

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    End point title
    		 Change from Baseline in Use of Rescue Medication at Week 16
    End point description
    Rescue medication is a relief medication for chronic obstructive pulmonary disease symptoms. example; when subjects feel breathless, chest tight, or frequent cough. The reduction of number of the occasions indicates disease improvement with less symptoms. mITT analysis set included subjects who received at least 1 or partial dose of study agent and had at least 1 post-treatment efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo CNTO 6785
    Number of subjects analysed
    93 [5]
    92 [6]
    Units: day
    arithmetic mean (standard deviation)
        Baseline
    4.37 ± 4.825
    3.91 ± 4.608
        Change at Week 16
    -1.03 ± 5.482
    -0.57 ± 4.703
    Notes
    [5] - Here "N" signifies number of subjects analysed for this endpoint.
    [6] - Here "N" signifies number of subjects analysed for this endpoint.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v CNTO 6785
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.843
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.762
         upper limit
    		 0.971

    Secondary: Change from Baseline in Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16

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    End point title
    		 Change from Baseline in Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
    End point description
    E-RS is a 11-item respiratory system scoring algorithm to assess the severity of respiratory symptoms in participants with chronic obstructive pulmonary disease (COPD). Each item has either 5 or 6 response options. Higher score indicates more severe COPD. mITT analysis set included subjects who received at least 1 or partial dose of study agent and had at least 1 post-treatment efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo CNTO 6785
    Number of subjects analysed
    93 [7]
    92 [8]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    13.29 ± 6.18
    13.12 ± 5.955
        Change at Week 16
    -1.22 ± 5.145
    -1.13 ± 4.54
    Notes
    [7] - Here "N" signifies number of subjects analysed for this endpoint.
    [8] - Here "N" signifies number of subjects analysed for this endpoint.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v CNTO 6785
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.953
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.077
         upper limit
    		 1.156

    Secondary: Change From Baseline in St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease (COPD) Subjects (SGRQ-C) at Week 16

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    End point title
    		 Change From Baseline in St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease (COPD) Subjects (SGRQ-C) at Week 16
    End point description
    SGRQ-C is a 40-item questionnaire designed to measure health impairment in participants with COPD. SGRQ-C is divided into two components: 1) symptoms, 2) activity and impacts. Total SGRQ-C score ranges from 0 (best) and 100 (worst). Higher scores indicate greater health impairment. mITT analysis set included subjects who received at least 1 or partial dose of study agent and had at least 1 post-treatment efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo CNTO 6785
    Number of subjects analysed
    89 [9]
    90 [10]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    48.7 ± 17.759
    51.58 ± 18.448
        Change at WeeK 16
    -1.94 ± 12.166
    -2.56 ± 13.099
    Notes
    [9] - Here "N" signifies number of subjects analysed for this endpoint.
    [10] - Here "N" signifies number of subjects analysed for this endpoint.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v CNTO 6785
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.922
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.246
         upper limit
    		 2.885

    Secondary: Number of Subjects With Antibodies to CNTO 6785 At Week 24

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    End point title
    		 Number of Subjects With Antibodies to CNTO 6785 At Week 24 [11]
    End point description
    The antibodies to CNTO 6785 analysis set was defined as all subjects who received at least a partial dose of CNTO 6785 and had evaluable samples for antibodies to CNTO 6785 assessment.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [11] - 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: Statistical analysis was not analysed for the outcome measure.
    End point values
    		 CNTO 6785
    Number of subjects analysed
    88 [12]
    Units: subjects
        Positive for antibodies to CNTO 6785
    6
        Negative for antibodies to CNTO 6785
    82
    Notes
    [12] - Here "N" signifies number of subjects analysed for this endpoint.
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
    End point description
    An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse events (SAE) is 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. The safety analysis set is defined as all subjects who had received at least a partial dose of study agent by the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to 24 Weeks
    End point values
    		 Placebo CNTO 6785
    Number of subjects analysed
    94
    92 [13]
    Units: subjects
        TEAEs
    51
    54
        Serious TEAEs
    7
    6
    Notes
    [13] - Here "N" signifies number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered by intravenous (IV) infusion (for not less than 30 minutes in duration) at Study Visit 3, Study Visit 5, Study Visit 6, Study Visit 7 and Study Visit 8.

    Reporting group title
    CNTO 6785
    Reporting group description
    		 CNTO 6785 6 milligram per kilogram (mg/kg) was administered by IV infusion (for not less than 30 minutes in duration) at Study Visit 3, Study Visit 5, Study Visit 6, Study Visit 7 and Study Visit 8.

    Serious adverse events
    		 Placebo CNTO 6785
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 94 (7.45%)
    6 / 92 (6.52%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haemothorax
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Paranasal Sinus Aplasia
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    2 / 94 (2.13%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 94 (1.06%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Dacryostenosis Acquired
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Polyps
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Septum Deviation
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    1 / 94 (1.06%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis Bacterial
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 94 (1.06%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 94 (2.13%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo CNTO 6785
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 94 (24.47%)
    27 / 92 (29.35%)
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    15 / 94 (15.96%)
    19 / 92 (20.65%)
         occurrences all number
    18
    26
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 94 (9.57%)
    10 / 92 (10.87%)
         occurrences all number
    9
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2014
    This Amendment 1 included the following changes in the protocol: 1) More frequent chemistry tests were added during the study to ensure all potential safety signals were captured timely; 2) Nasal brushing test was added as an optional choice for all non-bronchoscopy subjects to mitigate the potential risk of inadequate nasal epithelial samples if only collected from bronchoscopy subjects; 3) Extended the maximum screening period for tuberculosis screening from 4 weeks to 6 weeks; 4) Extended the maximum screening period for tuberculosis screening from 4 weeks to 6 weeks; 5) Clarified the exclusion criteria regarding previous episodes of chronic obstructive pulmonary disease (COPD) exacerbations; 6) Clarified that post-dose pharmacokinetic (PK) samples would be collected 1 hour after study agent administration; 7) Relieved subject load of unnecessary pre-bronchodilator spirometry test in the bronchoscopy subgroup at visit 9 if the bronchoscopy was performed on another day different from the efficacy evaluation day. The bronchoscopy eligibility was only related to the post-bronchodilator spirometry value; 8) Sampling dates/times for lab samples were captured on the requisition form but not in the electronic case report forms (eCRF); 9) Deleted unnecessary requirement on electrocardiogram (ECG) test; 10) Clarified that details of strata used for primary analysis were provided in the statistical analysis plan (SAP); 11) Physical examination was not analyzed and summarized by descriptive analysis; 12) Further clarified Independent Data Monitoring Committee (IDMC) performance and kept the statement to be consistent with IDMC charter and Specified that 5 percent (%) dextrose would be used either as diluent for CNTO 6785 or the placebo.

    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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