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    Clinical Trial Results:
    Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis

    Summary
    EudraCT number
    		 2014-004748-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Oct 2007

    Results information
    Results version number
    		 v3(current)
    This version publication date
    21 Aug 2016
    First version publication date
    19 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-367
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00442559
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Oct 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measures defined for this individual study were in place for the protection of subjects: adjunct daily inhaler (nebulized salbutamol) therapy on an as needed basis; rescue oral, intramuscular, or intravenous corticosteroid therapy for asthma attacks; and addition of inhaled corticosteroids to study treatments for exacerbation from mild to moderate asthma.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 9 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 191
    Worldwide total number of subjects
    191
    EEA total number of subjects
    0
    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)
    177
    Adolescents (12-17 years)
    14
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Conducted at 5 sites in Korea, Feb2005~ Dec2007 in pediatric participants with comorbid mild asthma and allergic rhinitis. Participant's caregiver understands the study procedures and agrees to participate, signing the informed consent form. Additional inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 Up to 1 week for wash-out - prior to baseline randomization.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Montelukast
    Arm description
    		 Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    montelukast sodium
    Investigational medicinal product code
    Other name
    Singulair, MK-0476
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months

    Arm title
    		 Inhaled Corticosteroids (ICS)
    Arm description
    		 Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    inhaled corticosteroid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

    Number of subjects in period 1
    		Montelukast Inhaled Corticosteroids (ICS)
    Started
    100
    91
    12 weeks after randomization
    68
    60
    Completed
    66
    56
    Not completed
    34
    35
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    32
    34
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Montelukast
    Reporting group description
    		 Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Reporting group title
    Inhaled Corticosteroids (ICS)
    Reporting group description
    		 Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Reporting group values
    		 Montelukast Inhaled Corticosteroids (ICS) Total
    Number of subjects
    		 100 91 191
    Age categorical
    Units: Subjects
    Age Continuous
    24 participants were included in the Montelukast group and 29 participants were included in the ICS group.
    Units: years
        arithmetic mean (standard deviation)
    		 5.4 ( 3 ) 6.1 ( 2.6 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 5 9 14
        Male
    		 19 20 39
        Not reported
    		 76 62 138
    Allergic rhinitis
    Based on GINA guidelines.
    Units: Subjects
        Mild-intermittent
    		 14 17 31
        Mild-persistent
    		 10 12 22
        Not reported
    		 76 62 138
    Type of allergic rhinitis
    Units: Subjects
        Seasonal
    		 13 15 28
        Perennial
    		 11 14 25
        Not reported
    		 76 62 138
    Daily allergic rhinitis symptom score
    The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). 24 participants with baseline scores were included in the Montelukast group and 28 participants with baseline scores were included in the ICS group.
    Units: Units on scale
        arithmetic mean (standard deviation)
    		 0.45 ( 0.35 ) 0.31 ( 0.34 ) -
    Daytime asthma symptom score
    The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). 24 participants with baseline scores were included in the Montelukast group and 29 participants with baseline scores were included in the ICS group.
    Units: Units on scale
        arithmetic mean (standard deviation)
    		 0.32 ( 0.42 ) 0.29 ( 0.4 ) -
    Duration of allergic rhinitis
    24 participants were included in the Montelukast group and 28 participants were included in the ICS group.
    Units: Years
        arithmetic mean (standard deviation)
    		 0.4 ( 0.6 ) 0.8 ( 1 ) -
    Duration of asthma
    24 participants were included in the Montelukast group and 29 participants were included in the ICS group.
    Units: Years
        arithmetic mean (standard deviation)
    		 0.6 ( 0.7 ) 1.1 ( 1.2 ) -

    End points

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    End points reporting groups
    Reporting group title
    Montelukast
    Reporting group description
    		 Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Reporting group title
    Inhaled Corticosteroids (ICS)
    Reporting group description
    		 Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daytime Asthma Symptom Score at Baseline - Montelukast
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daytime Asthma Symptom Score at 12 Weeks - Montelukast
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daytime Asthma Symptom Score at Baseline - ICS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daytime Asthma Symptom Score at 12 Weeks - ICS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daily Allergic Rhinitis Symptom Score at Baseline - ICS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Subject analysis set title
    Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

    Primary: Change from Baseline for Daytime Asthma Symptom Score

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    End point title
    		 Change from Baseline for Daytime Asthma Symptom Score
    End point description
    The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline (Statistical Analyses: Change from BL to Week 12 - Montelukast; Change from BL to Week 12 - ICS). Thus, a negative value for change from baseline indicates a favorable outcome. The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Daytime Asthma Symptom Score at Baseline - Montelukast Daytime Asthma Symptom Score at 12 Weeks - Montelukast Daytime Asthma Symptom Score at Baseline - ICS Daytime Asthma Symptom Score at 12 Weeks - ICS
    Number of subjects analysed
    24
    24
    29
    29
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.32 ( 0.42 )
    0.16 ( 0.35 )
    0.29 ( 0.4 )
    0.13 ( 0.27 )
    Statistical analysis title
    		 Change from BL to Week 12 - Montelukast
    Statistical analysis description
    The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group.
    Comparison groups
    Daytime Asthma Symptom Score at Baseline - Montelukast v Daytime Asthma Symptom Score at 12 Weeks - Montelukast
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.015
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 -0.03
    Notes
    [1] - Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.
    Statistical analysis title
    		 Change from BL to Week 12 - ICS
    Statistical analysis description
    The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group.
    Comparison groups
    Daytime Asthma Symptom Score at Baseline - ICS v Daytime Asthma Symptom Score at 12 Weeks - ICS
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.027
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 -0.02
    Notes
    [2] - Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.

    Secondary: Change from Baseline for Daily Allergic Rhinitis Symptom Score

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    End point title
    		 Change from Baseline for Daily Allergic Rhinitis Symptom Score
    End point description
    The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline (Statistical Analyses: Change from BL to Week 12 - Montelukast; Change from BL to Week 12 - ICS). Thus, a negative value for change from baseline indicates a favorable outcome. The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast Daily Allergic Rhinitis Symptom Score at Baseline - ICS Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS
    Number of subjects analysed
    24
    24
    28
    28
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.45 ( 0.35 )
    0.23 ( 0.26 )
    0.31 ( 0.34 )
    0.19 ( 0.26 )
    Statistical analysis title
    		 Change from BL to Week 12 - Montelukast
    Statistical analysis description
    The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group.
    Comparison groups
    Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast v Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.006
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 -0.07
    Notes
    [3] - Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.
    Statistical analysis title
    		 Change from BL to Week 12 - ICS
    Statistical analysis description
    The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group.
    Comparison groups
    Daily Allergic Rhinitis Symptom Score at Baseline - ICS v Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.032
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 -0.01
    Notes
    [4] - Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Montelukast
    Reporting group description
    		 Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening.

    Reporting group title
    Inhaled Corticosteroids (ICS)
    Reporting group description
    		 Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen.

    Serious adverse events
    		 Montelukast Inhaled Corticosteroids (ICS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 100 (4.00%)
    3 / 91 (3.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    VOMITING
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 91 (1.10%)
         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
    ASTHMA
         subjects affected / exposed
    3 / 100 (3.00%)
    2 / 91 (2.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 91 (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
    CHRONIC SINUSITIS
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    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
    		 Montelukast Inhaled Corticosteroids (ICS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    83 / 100 (83.00%)
    70 / 91 (76.92%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    9 / 100 (9.00%)
    10 / 91 (10.99%)
         occurrences all number
    9
    11
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    31 / 100 (31.00%)
    24 / 91 (26.37%)
         occurrences all number
    41
    34
    Gastrointestinal disorders
    VOMITING
         subjects affected / exposed
    6 / 100 (6.00%)
    7 / 91 (7.69%)
         occurrences all number
    6
    7
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    56 / 100 (56.00%)
    47 / 91 (51.65%)
         occurrences all number
    88
    92
    DYSPNOEA
         subjects affected / exposed
    7 / 100 (7.00%)
    5 / 91 (5.49%)
         occurrences all number
    10
    6
    NASAL DISCOMFORT
         subjects affected / exposed
    15 / 100 (15.00%)
    8 / 91 (8.79%)
         occurrences all number
    21
    9
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    7 / 100 (7.00%)
    8 / 91 (8.79%)
         occurrences all number
    8
    10
    PRODUCTIVE COUGH
         subjects affected / exposed
    12 / 100 (12.00%)
    12 / 91 (13.19%)
         occurrences all number
    12
    17
    RHINORRHOEA
         subjects affected / exposed
    27 / 100 (27.00%)
    21 / 91 (23.08%)
         occurrences all number
    36
    30
    UPPER AIRWAY OBSTRUCTION
         subjects affected / exposed
    30 / 100 (30.00%)
    30 / 91 (32.97%)
         occurrences all number
    42
    43
    SNEEZING
         subjects affected / exposed
    21 / 100 (21.00%)
    18 / 91 (19.78%)
         occurrences all number
    29
    26
    WHEEZING
         subjects affected / exposed
    9 / 100 (9.00%)
    13 / 91 (14.29%)
         occurrences all number
    10
    15
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 91 (2.20%)
         occurrences all number
    6
    2
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    9 / 100 (9.00%)
    7 / 91 (7.69%)
         occurrences all number
    9
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This was an open-label study. Only 53 patients had diary information with daytime asthma symptom score - thus, 138 cases were dropped from analysis due to lack of daytime asthma symptom score.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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