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    Clinical Trial Results:
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects with Uncontrolled, Persistent Asthma

    Summary
    EudraCT number
    		 2012-004920-39
    Trial protocol
    		 GB   DE   IT  
    Global end of trial date
    23 Jul 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    38518168ASH2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01823016
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Archimedesweg 29-2333CM, Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, 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
    23 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to assess the efficacy (as measured by the change from baseline in prebronchodilator [preBD] percent-predicted forced expiratory volume in 1 second [FEV1]) of JNJ 38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment (inhaled corticosteroids [ICS] with or without long-acting beta-2-agonist [LABA], montelukast).
    Protection of trial subjects
    The safety assessments included clinical laboratory tests (hematology, serum chemistry and urinalysis), spirometry, electrocardiogram (ECG), vital signs and physical examinations. Adverse events were assessed throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 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
    Canada: 15
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Israel: 22
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    United States: 61
    Worldwide total number of subjects
    165
    EEA total number of subjects
    67
    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)
    146
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 82 of the 83 subjects randomized to the placebo group were treated with placebo and 82 of the 82 subjects randomized to the JNJ-38518168 30 mg group were treated with JNJ‑38518168 30 mg.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching Placebo film coated tablet orally once daily for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo film coated tablet orally once daily for 24 Weeks.

    Arm title
    		 JNJ-38518168, 30 milligram (mg)
    Arm description
    		 Subjects received JNJ-38518168 30 milligram film coated tablet orally once daily for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-38518168
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-38518168 30 mg film coated tablet orally once daily for 24 Weeks.

    Number of subjects in period 1
    		Placebo JNJ-38518168, 30 milligram (mg)
    Started
    83
    82
    Completed
    65
    68
    Not completed
    18
    14
         Consent withdrawn by subject
    4
    5
         Adverse event, non-fatal
    4
    2
         Other
    9
    6
         Lost to follow-up
    -
    1
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching Placebo film coated tablet orally once daily for 24 weeks.

    Reporting group title
    JNJ-38518168, 30 milligram (mg)
    Reporting group description
    		 Subjects received JNJ-38518168 30 milligram film coated tablet orally once daily for 24 weeks.

    Reporting group values
    		 Placebo JNJ-38518168, 30 milligram (mg) Total
    Number of subjects
    		 83 82 165
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 75 71 146
        From 65 to 84 years
    		 8 11 19
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.5 ± 12.63 48.8 ± 13.25 -
    Title for Gender
    Units: subjects
        Female
    		 46 40 86
        Male
    		 37 42 79

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching Placebo film coated tablet orally once daily for 24 weeks.

    Reporting group title
    JNJ-38518168, 30 milligram (mg)
    Reporting group description
    		 Subjects received JNJ-38518168 30 milligram film coated tablet orally once daily for 24 weeks.

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

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    End point title
    		 Change From Baseline in Prebronchodilator (preBD) Percent Predicted Forced Expiratory Volume in one Second (FEV1) at Week 16
    End point description
    FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function. The modified intent-to-treat (mITT) analysis set included all randomized subjects who received at least one dose (partial or complete) of study agent and had at least 1 post treatment efficacy measurement. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo JNJ-38518168, 30 milligram (mg)
    Number of subjects analysed
    82
    82
    Units: percent change
    arithmetic mean (standard deviation)
        Baseline (n= 82, 82)
    62.84 ± 9.773
    62.77 ± 10.528
        Change at Week 16 (n= 81, 82)
    3.72 ± 8.976
    3.53 ± 9.203
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-38518168, 30 milligram (mg)
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.896
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) means difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.01
         upper limit
    		 2.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.431

    Secondary: Change From Baseline in Asthma Control Questionnaire (ACQ) at Week 16

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    End point title
    		 Change From Baseline in Asthma Control Questionnaire (ACQ) at Week 16
    End point description
    ACQ is used to evaluate asthma control, the full range of clinical impairment (well controlled to life threatening) for the participant with asthma. There are 7 questions (5 for symptoms [night-time awakenings, morning symptoms, limitation of activities, shortness of breath, and wheezing], use of daily rescue bronchodilator, and percent predicted forced expiratory volume value). All 7 items are scored on a 7-point scale (0 = good control, 6 = poor control), with the mean score as an overall summary score. The recall period is 7 days. Higher scores indicate worsening. The mITT analysis set included all randomized subjects who received at least one dose (partial or complete) of study agent and had at least 1 post treatment efficacy measurement. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo JNJ-38518168, 30 milligram (mg)
    Number of subjects analysed
    82
    82
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 82, 82)
    2.54 ± 0.628
    2.43 ± 0.512
        Change at Week 16 (n= 81, 82)
    -0.77 ± 0.734
    -0.65 ± 0.743
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    JNJ-38518168, 30 milligram (mg) v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.512
    Method
    		 ANCOVA
    Parameter type
    		 LS means difference
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.113

    Secondary: Change From Baseline in Postbronchodilator (postBD) Percent-Predicted FEV1 at Week 16

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    End point title
    		 Change From Baseline in Postbronchodilator (postBD) Percent-Predicted FEV1 at Week 16
    End point description
    FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function. The modified intent-to-treat (mITT) analysis set included all randomized subjects who received at least one dose (partial or complete) of study agent and had at least 1 post treatment efficacy measurement. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo JNJ-38518168, 30 milligram (mg)
    Number of subjects analysed
    82
    82
    Units: percent change
    arithmetic mean (standard deviation)
        Baseline (n= 82, 82)
    76.6 ± 12.702
    75.5 ± 13.243
        Change at Week 16 (n= 80, 82)
    -1.15 ± 6.121
    -0.62 ± 6.827
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-38518168, 30 milligram (mg)
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 ANCOVA
    Parameter type
    		 LS means difference
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 2.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.021

    Secondary: Change From Baseline in Weekly Average of Daytime Asthma Diary Symptom Score at Week 16

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    End point title
    		 Change From Baseline in Weekly Average of Daytime Asthma Diary Symptom Score at Week 16
    End point description
    Asthma symptom diary score is an index to access the severity of asthma related symptoms. The symptoms are wheezing, coughing, chest tightness and trouble breathing. The severity of each symptom is assessed by a 5-point ranking scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe, 4 = extremely severe). Subjects are instructed to score and document their symptoms through e-diary every morning and evening. Daytime asthma symptom score is defined as the average of the four symptom scores collected in evening diaries. The modified intent-to-treat (mITT) analysis set included all randomized subjects who received at least one dose (partial or complete) of study agent and had at least 1 post treatment efficacy measurement. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo JNJ-38518168, 30 milligram (mg)
    Number of subjects analysed
    82
    82
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 82, 82)
    0.54 ± 0.472
    0.42 ± 0.35
        Change at Week 16 (n= 81, 81)
    -0.25 ± 0.406
    -0.2 ± 0.349
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-38518168, 30 milligram (mg)
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.794
    Method
    		 Rank Analysis of Covariance
    Parameter type
    		 Median difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.14

    Secondary: Change From Baseline in Weekly Average of Nighttime Asthma Diary Symptom Score at Week 16

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    End point title
    		 Change From Baseline in Weekly Average of Nighttime Asthma Diary Symptom Score at Week 16
    End point description
    Asthma symptom diary score is an index to access the severity of asthma related symptoms. The symptoms are wheezing, coughing, chest tightness and trouble breathing. The severity of each symptom is assessed by a 5-point ranking scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe, 4 = extremely severe). Subjects are instructed to score and document their symptoms through e-diary every morning and evening. Nighttime asthma symptom score is defined as the average of the four symptom scores collected in morning diaries. The modified intent-to-treat (mITT) analysis set included all randomized subjects who received at least one dose (partial or complete) of study agent and had at least 1 post treatment efficacy measurement. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo JNJ-38518168, 30 milligram (mg)
    Number of subjects analysed
    82
    82
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 82, 82)
    0.39 ± 0.449
    0.19 ± 0.246
        Change at Week 16 (n= 81, 81)
    -0.2 ± 0.359
    -0.11 ± 0.228
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-38518168, 30 milligram (mg)
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.295
    Method
    		 Rank Analysis of Covariance
    Parameter type
    		 Median difference (net)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.09

    Secondary: Change From Baseline in Weekly Average of Number of Puffs in a day That Rescue Medication was Used at Week 16

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    End point title
    		 Change From Baseline in Weekly Average of Number of Puffs in a day That Rescue Medication was Used at Week 16
    End point description
    The weekly average of number of puffs in daytime (nighttime) that rescue medication is used for a particular visit (excluding Baseline visit) is calculated as sum of the weekly average of number of puffs in daytime and nighttime the week (7-day period) prior to the visit. The 7-day period does not include the day of visit. If less than 4 data points are available for daytime (nighttime) rescue medication use, the daytime (nighttime) assessment was considered missing. The modified intent-to-treat (mITT) analysis set included all randomized subjects who received at least one dose (partial or complete) of study agent and had at least 1 post treatment efficacy measurement. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo JNJ-38518168, 30 milligram (mg)
    Number of subjects analysed
    82
    82
    Units: number of puffs
    arithmetic mean (standard deviation)
        Baseline (n= 82, 82)
    2.46 ± 2.2
    2.03 ± 2.169
        Change at Week 16 (n= 81, 81)
    -0.86 ± 1.595
    -0.82 ± 1.856
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-38518168, 30 milligram (mg)
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.56
    Method
    		 Rank Analysis of Covariance
    Parameter type
    		 Median difference (net)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.67

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First study agent administration up to follow up (Week 28)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching Placebo tablet orally once daily for 24 weeks.

    Reporting group title
    JNJ-38518168, 30 mg
    Reporting group description
    		 Subjects received JNJ-38518168 30 mg tablet orally once daily for 24 Weeks.

    Serious adverse events
    		 Placebo JNJ-38518168, 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo JNJ-38518168, 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 82 (58.54%)
    50 / 82 (60.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 82 (1.22%)
    8 / 82 (9.76%)
         occurrences all number
    1
    11
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 82 (2.44%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Pyrexia
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Eye disorders
    Conjunctivitis Allergic
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    4 / 82 (4.88%)
    4 / 82 (4.88%)
         occurrences all number
    4
    6
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    20 / 82 (24.39%)
    24 / 82 (29.27%)
         occurrences all number
    29
    37
    Cough
         subjects affected / exposed
    3 / 82 (3.66%)
    3 / 82 (3.66%)
         occurrences all number
    3
    3
    Dyspnoea
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 82 (2.44%)
         occurrences all number
    3
    2
    Epistaxis
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 82 (2.44%)
         occurrences all number
    0
    2
    Nasal Congestion
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Oropharyngeal Pain
         subjects affected / exposed
    2 / 82 (2.44%)
    3 / 82 (3.66%)
         occurrences all number
    2
    3
    Rhinitis Allergic
         subjects affected / exposed
    1 / 82 (1.22%)
    3 / 82 (3.66%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences all number
    2
    0
    Back Pain
         subjects affected / exposed
    2 / 82 (2.44%)
    2 / 82 (2.44%)
         occurrences all number
    2
    3
    Muscle Spasms
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    3 / 82 (3.66%)
    1 / 82 (1.22%)
         occurrences all number
    3
    1
    Bronchitis
         subjects affected / exposed
    8 / 82 (9.76%)
    1 / 82 (1.22%)
         occurrences all number
    10
    1
    Cystitis
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    11 / 82 (13.41%)
    10 / 82 (12.20%)
         occurrences all number
    14
    12
    Oral Candidiasis
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    3 / 82 (3.66%)
    3 / 82 (3.66%)
         occurrences all number
    3
    3
    Sinusitis
         subjects affected / exposed
    6 / 82 (7.32%)
    3 / 82 (3.66%)
         occurrences all number
    6
    4
    Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 82 (7.32%)
    9 / 82 (10.98%)
         occurrences all number
    10
    9
    Urinary Tract Infection
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 82 (2.44%)
         occurrences all number
    3
    2
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 82 (2.44%)
         occurrences all number
    3
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    The amendment includes the following substantial changes: Based upon preliminary pharmacokinetic (PK) results from the 38518168ARA1003 drug-drug interaction (DDI) study with ketoconazole (a potent CYP3A4/Pgp inhibitor), information regarding DDIs, criteria for subject enrollment, and the list of prohibited medications were updated, allowing greater flexibility in subject enrollment and choice of concomitant medications; Total Nasal and Ocular Symptom Score (TNOSS) assessment was removed from Screening Visit 2 as this assessment was not required at this time point; clarification of wording for primary endpoint and hypothesis; clarification of statistical sections; clarification of repeat testing for induced sputum; clarification added regarding dosing of study agent with water; text regarding epigenetic testing was added; clarification added on ferritin unit values and text on retesting to inclusion criterion #10; clarification added on background inhaled corticosteroids (ICS), long-acting beta-2-agonist (LABA), and montelukast use for stratification; added clarifying text on electrocardiogram (ECG) that if the repeat QTcF continues to be above 480 msec based on the central cardiologist's overread, the study medication should be discontinued; list of substrates of CYP2C8 was revised to include montelukast, which was recently identified as a CYP2C8 substrate in clinical studies; added clarifying text for definition of asthma exacerbations as an emergency room visit because of asthma requiring treatment with systemic corticosteroids for at least 3 consecutive days; a criterion was added excluding women from donating eggs.

    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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