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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared with Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

    Summary
    EudraCT number
    		 2006-002791-18
    Trial protocol
    		 FI   DK   DE   IT   LT   FR   Outside EU/EEA  
    Global end of trial date
    12 Aug 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2016
    First version publication date
    05 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00337675
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MK-0476-302: Merck Registration
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000012-PIP01-07
    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
    12 Aug 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the regimen-related efficacy of montelukast (daily dosing and intermittent, episode-driven dosing) compared with placebo in decreasing the number of asthma episodes culminating in asthma attack over a 52-week treatment period.
    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 measure defined for this individual study was in place for the protection of trial subjects: Participants were provided with short-acting ß-agonist (SABA; oral, inhaled or nebulized) which was to be used every 4 to 6 hours as needed throughout the study. The formulation of SABA was provided by investigators to participants according to the investigator's usual clinical practice.
    Background therapy
    		 Participants were provided with SABA (oral, inhaled or nebulized) which was to be used every 4 to 6 hours as needed throughout the study. The formulation of SABA was provided by investigators to participants according to the investigator's usual clinical practice.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2006
    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
    Australia: 35
    Country: Number of subjects enrolled
    Brazil: 77
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    Chile: 228
    Country: Number of subjects enrolled
    Colombia: 154
    Country: Number of subjects enrolled
    Costa Rica: 251
    Country: Number of subjects enrolled
    Guatemala: 120
    Country: Number of subjects enrolled
    Israel: 47
    Country: Number of subjects enrolled
    Mexico: 159
    Country: Number of subjects enrolled
    Russian Federation: 139
    Country: Number of subjects enrolled
    Singapore: 39
    Country: Number of subjects enrolled
    South Africa: 98
    Country: Number of subjects enrolled
    United States: 163
    Country: Number of subjects enrolled
    Peru: 128
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    Finland: 30
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Italy: 24
    Country: Number of subjects enrolled
    Lithuania: 3
    Worldwide total number of subjects
    1771
    EEA total number of subjects
    106
    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)
    277
    Children (2-11 years)
    1494
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 Pediatric participants who were 6 months to 5 years of age and had episodic asthma were screened for this study.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daily Montelukast
    Arm description
    		 Participants received montelukast 4-5 mg (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Chewable tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 4-5 mg, once daily at bedtime for 52 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, once daily at bedtime for 12 days as needed for symptoms of imminent respiratory infection or episode of breathing problems

    Arm title
    		 Intermittent Montelukast
    Arm description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4-5 mg (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, once daily at bedtime for 52 weeks

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Chewable tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 4-5 mg, once daily at bedtime for 12 days as needed for symptoms of imminent respiratory infection or episode of breathing problems

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, once daily at bedtime for 52 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, once daily at bedtime for 12 days as needed for symptoms of imminent respiratory infection or episode of breathing problems

    Number of subjects in period 1
    		Daily Montelukast Intermittent Montelukast Placebo
    Started
    589
    591
    591
    Treated
    587
    589
    590
    Completed
    492
    488
    492
    Not completed
    97
    103
    99
         Physician decision
    9
    17
    14
         Consent withdrawn by subject
    25
    25
    19
         Trial terminated
    -
    -
    2
         Adverse event, non-fatal
    10
    9
    19
         Lost to follow-up
    22
    19
    17
         Progressive disease
    -
    2
    -
         Lack of efficacy
    10
    7
    9
         Protocol deviation
    21
    24
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Daily Montelukast
    Reporting group description
    		 Participants received montelukast 4-5 mg (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group title
    Intermittent Montelukast
    Reporting group description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4-5 mg (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group values
    		 Daily Montelukast Intermittent Montelukast Placebo Total
    Number of subjects
    		 589 591 591 1771
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 86 92 99 277
        Children (2-11 years)
    		 503 499 492 1494
    Gender categorical
    Units: Subjects
        Female
    		 239 226 238 703
        Male
    		 350 365 353 1068

    End points

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    End points reporting groups
    Reporting group title
    Daily Montelukast
    Reporting group description
    		 Participants received montelukast 4-5 mg (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group title
    Intermittent Montelukast
    Reporting group description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4-5 mg (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Primary: Number of Asthma Episodes Culminating in Asthma Attack Over the 52-week Treatment Period

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    End point title
    		 Number of Asthma Episodes Culminating in Asthma Attack Over the 52-week Treatment Period
    End point description
    The rate per year of asthma episodes culminating in an asthma attack is presented. An asthma episode started the day intermittent treatment was initiated. An asthma episode ended when intermittent treatment of the episode was stopped (treatment lasted for 12 calendar days) or when a "No" was recorded for both questions on the Symptom Calendar, whichever was longer. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal or inhaled), or hospitaliation. Each day during an asthma episode, the participant's guardian recorded all the HRU that was required spcifically for breathing problems.
    End point type
    Primary
    End point timeframe
    52 weeks
    End point values
    		 Daily Montelukast Intermittent Montelukast Placebo
    Number of subjects analysed
    584 [1]
    588 [2]
    585 [3]
    Units: Number of asthma episodes
        arithmetic mean (confidence interval 95%)
    0.99 (0.86 to 1.14)
    1.06 (0.92 to 1.22)
    1.05 (0.92 to 1.2)
    Notes
    [1] - All randomized participants who took ≥1 dose of study drug and were evaluable for this end point.
    [2] - All randomized participants who took ≥1 dose of study drug and were evaluable for this end point.
    [3] - All randomized participants who took ≥1 dose of study drug and were evaluable for this end point.
    Statistical analysis title
    		 Rate Ratio of Daily Montelukast vs. Placebo
    Statistical analysis description
    Rate ratio of Daily Montelukast compared to Placebo for the number of asthma episodes culminating in asthma attacks. Analysis is based on Poisson regression with factors for treatment, age category and geographical region.
    Comparison groups
    Daily Montelukast v Placebo
    Number of subjects included in analysis
    1169
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.51 [4]
    Method
    		 Poisson Regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.11
    Notes
    [4] - Multiplicity adjustment across regimens was addressed through step-down testing. Daily Montelukast vs. Placebo was tested first; if this comparison was significant, Intermittent Montelukast vs. Placebo was tested. The significance level was 5%.
    Statistical analysis title
    		 Rate Ratio of Intermittent Montelukast vs. Placebo
    Statistical analysis description
    Rate ratio of Intermittent Montelukast compared to Placebo for the number of asthma episodes culminating in asthma attacks. Analysis is based on Poisson regression with factors for treatment, age category and geographical region.
    Comparison groups
    Intermittent Montelukast v Placebo
    Number of subjects included in analysis
    1173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.884 [5]
    Method
    		 Poisson Regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.19
    Notes
    [5] - Multiplicity adjustment across regimens was addressed through step-down testing. Daily Montelukast vs. Placebo was tested first; if this comparison was significant, Intermittent Montelukast vs. Placebo was tested. The significance level was 5%.

    Secondary: Daily Average of Wheeze and Difficulty Breathing Score in the 3 Days Prior to Start of Asthma Attack

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    End point title
    		 Daily Average of Wheeze and Difficulty Breathing Score in the 3 Days Prior to Start of Asthma Attack
    End point description
    Each day during an asthma episode, the participant's guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (0=best to 5=worst). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was calculated. If a participant had multiple episodes during the 52-week study period, the symptom scores were averaged across all episodes. Only participants who experienced an asthma attack within an episode and did not start their intermittent study drug on the day of the attack were included in this analysis.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Daily Montelukast Intermittent Montelukast Placebo
    Number of subjects analysed
    138 [6]
    162 [7]
    152 [8]
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    1.69 (1.49 to 1.88)
    1.7 (1.52 to 1.89)
    1.88 (1.69 to 2.07)
    Notes
    [6] - Participants who had an asthma attack and did not start intermittent study drug on day of attack.
    [7] - Participants who had an asthma attack and did not start intermittent study drug on day of attack.
    [8] - Participants who had an asthma attack and did not start intermittent study drug on day of attack.
    Statistical analysis title
    		 Difference in Pre-attack Scores
    Statistical analysis description
    Difference in least squares (LS) means of Daily Montelukast compared to Placebo for the daily average of wheeze and difficulty breathing score in the 3 days prior to the start of an asthma attack. Analysis based on analysis of variance (ANOVA) with terms for treatment, age category and geographical region.
    Comparison groups
    Daily Montelukast v Placebo
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.176 [9]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.09
    Notes
    [9] - Multiplicity adjustment across regimens and across primary and secondary end points was addressed through step-down testing. Within the 2 secondary end points assessing severity, adjustment for multiplicity was performed using Hochberg's method.
    Statistical analysis title
    		 Difference in Pre-attack Scores
    Statistical analysis description
    Difference in LS means of Intermittent Montelukast compared to Placebo for the daily average of wheeze and difficulty breathing score in the 3 days prior to the start of an asthma attack. Analysis based on ANOVA with terms for treatment, age category and geographical region.
    Comparison groups
    Intermittent Montelukast v Placebo
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.202 [10]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 0.09
    Notes
    [10] - Multiplicity adjustment across regimens and across primary and secondary end points was addressed through step-down testing. Within the 2 secondary end points assessing severity, adjustment for multiplicity was performed using Hochberg's method.

    Secondary: Daily Average of Wheeze, Difficulty Breathing, Daytime Cough, and Interference with Daily Activity Score Over the 12-day Treatment Period of an Asthma Episode (Before Asthma Attack)

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    End point title
    		 Daily Average of Wheeze, Difficulty Breathing, Daytime Cough, and Interference with Daily Activity Score Over the 12-day Treatment Period of an Asthma Episode (Before Asthma Attack)
    End point description
    Each day during an asthma episode, the participant's guardian was asked to rate each of the symptoms of wheeze, difficulty breathing, daytime cough, and interference with daily activity on a 6-point scale (0=best to 5=worst). The average of the individual symptoms on each of the 12 days of intermittent treatment for an asthma episode (before the first attack) was reported. If a participant had multiple episodes over the 52-week treatment period, the symptom scores were averaged across all the episodes. Only participants who had ≥1 asthma episode that culminated in an asthma attack were included in the analysis.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Daily Montelukast Intermittent Montelukast Placebo
    Number of subjects analysed
    365 [11]
    387 [12]
    368 [13]
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    1.08 (1 to 1.16)
    1.09 (1.01 to 1.17)
    1.2 (1.12 to 1.28)
    Notes
    [11] - Participants who had ≥1 asthma episode that culminated in an asthma attack.
    [12] - Participants who had ≥1 asthma episode that culminated in an asthma attack.
    [13] - Participants who had ≥1 asthma episode that culminated in an asthma attack.
    Statistical analysis title
    		 Difference in Asthma Episode Scores
    Statistical analysis description
    Difference in LS means of Daily Montelukast compared to Placebo for daily average of wheeze, difficulty breathing, daytime cough, and interference with daily activity score over the 12-day treatment period of an asthma episode (before attack). Analysis based on ANOVA with terms for treatment, age category and geographical region.
    Comparison groups
    Daily Montelukast v Placebo
    Number of subjects included in analysis
    733
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.045 [14]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS means
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0
    Notes
    [14] - Multiplicity adjustment across regimens and across primary and secondary end points was addressed through step-down testing. Within the 2 secondary end points assessing severity, adjustment for multiplicity was performed using Hochberg's method.
    Statistical analysis title
    		 Difference in Asthma Episode Scores
    Statistical analysis description
    Difference in LS means of Intermittent Montelukast compared to Placebo for daily average of wheeze, difficulty breathing, daytime cough, and interference with daily activity score over the 12-day treatment period of an asthma episode (before attack). Analysis based on ANOVA with terms for treatment, age category and geographical region.
    Comparison groups
    Intermittent Montelukast v Placebo
    Number of subjects included in analysis
    755
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061 [15]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS means
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0
    Notes
    [15] - Multiplicity adjustment across regimens and across primary and secondary end points was addressed through step-down testing. Within the 2 secondary end points assessing severity, adjustment for multiplicity was performed using Hochberg's method.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks
    Adverse event reporting additional description
    Population includes all randomized participants who received ≥1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Daily Montelukast
    Reporting group description
    		 Participants received montelukast 4-5 mg (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group title
    Intermittent Montelukast
    Reporting group description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4-5 mg (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (chewable tablets or oral granules, depending on participant age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching placebo (chewable tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

    Serious adverse events
    		 Daily Montelukast Intermittent Montelukast Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 584 (4.79%)
    41 / 588 (6.97%)
    33 / 585 (5.64%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Accidental poisoning
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    1 / 584 (0.17%)
    1 / 588 (0.17%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 584 (0.17%)
    1 / 588 (0.17%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    13 / 584 (2.23%)
    17 / 588 (2.89%)
    14 / 585 (2.39%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 20
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    2 / 584 (0.34%)
    4 / 588 (0.68%)
    3 / 585 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Synovitis
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenoiditis
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 584 (0.17%)
    2 / 588 (0.34%)
    2 / 585 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngotracheitis obstructive
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parotid abscess
         subjects affected / exposed
    1 / 584 (0.17%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 584 (0.51%)
    4 / 588 (0.68%)
    4 / 585 (0.68%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 584 (0.17%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 584 (0.34%)
    2 / 588 (0.34%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 584 (0.00%)
    1 / 588 (0.17%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 584 (0.00%)
    0 / 588 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    1 / 584 (0.17%)
    0 / 588 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 584 (0.17%)
    1 / 588 (0.17%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daily Montelukast Intermittent Montelukast Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    481 / 584 (82.36%)
    506 / 588 (86.05%)
    486 / 585 (83.08%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    94 / 584 (16.10%)
    87 / 588 (14.80%)
    80 / 585 (13.68%)
         occurrences all number
    148
    133
    139
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    35 / 584 (5.99%)
    49 / 588 (8.33%)
    43 / 585 (7.35%)
         occurrences all number
    49
    61
    45
    Vomiting
         subjects affected / exposed
    22 / 584 (3.77%)
    31 / 588 (5.27%)
    30 / 585 (5.13%)
         occurrences all number
    26
    38
    38
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    332 / 584 (56.85%)
    338 / 588 (57.48%)
    319 / 585 (54.53%)
         occurrences all number
    834
    944
    807
    Cough
         subjects affected / exposed
    91 / 584 (15.58%)
    101 / 588 (17.18%)
    93 / 585 (15.90%)
         occurrences all number
    261
    259
    266
    Rhinitis allergic
         subjects affected / exposed
    46 / 584 (7.88%)
    44 / 588 (7.48%)
    31 / 585 (5.30%)
         occurrences all number
    64
    62
    40
    Wheezing
         subjects affected / exposed
    33 / 584 (5.65%)
    31 / 588 (5.27%)
    37 / 585 (6.32%)
         occurrences all number
    87
    87
    103
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    33 / 584 (5.65%)
    40 / 588 (6.80%)
    32 / 585 (5.47%)
         occurrences all number
    60
    72
    72
    Influenza
         subjects affected / exposed
    30 / 584 (5.14%)
    31 / 588 (5.27%)
    27 / 585 (4.62%)
         occurrences all number
    59
    54
    51
    Nasopharyngitis
         subjects affected / exposed
    110 / 584 (18.84%)
    110 / 588 (18.71%)
    81 / 585 (13.85%)
         occurrences all number
    253
    230
    198
    Otitis media
         subjects affected / exposed
    44 / 584 (7.53%)
    55 / 588 (9.35%)
    45 / 585 (7.69%)
         occurrences all number
    63
    70
    62
    Pharyngitis
         subjects affected / exposed
    59 / 584 (10.10%)
    64 / 588 (10.88%)
    67 / 585 (11.45%)
         occurrences all number
    75
    82
    84
    Rhinitis
         subjects affected / exposed
    36 / 584 (6.16%)
    33 / 588 (5.61%)
    30 / 585 (5.13%)
         occurrences all number
    61
    52
    42
    Sinusitis
         subjects affected / exposed
    39 / 584 (6.68%)
    49 / 588 (8.33%)
    27 / 585 (4.62%)
         occurrences all number
    51
    62
    38
    Tonsillitis
         subjects affected / exposed
    38 / 584 (6.51%)
    42 / 588 (7.14%)
    37 / 585 (6.32%)
         occurrences all number
    41
    44
    41
    Upper respiratory tract infection
         subjects affected / exposed
    81 / 584 (13.87%)
    76 / 588 (12.93%)
    82 / 585 (14.02%)
         occurrences all number
    189
    172
    184
    Varicella
         subjects affected / exposed
    36 / 584 (6.16%)
    15 / 588 (2.55%)
    28 / 585 (4.79%)
         occurrences all number
    36
    15
    28

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2006
    Amendment 01: The Pre-Episode Symptom List was added to be reviewed with the study coordinator to identify symptoms the participant usually experiences prior to developing an episode of breathing problems. General: “Respiratory Symptom Calendar” was changed to “Symptom Calendar”. References to respiratory symptoms were removed and aligned with symptoms chosen by the parent/guardian on the Pre-Episode Symptom List. “Supplemental Medication” was changed to “Episode Medication”. In Episode Diary, the question on severity of nose symptoms was removed. Used medication and health resource utilization (HRU) for “breathing problems” instead of “respiratory symptoms”. Question on HRU was added: “What made you take your child for this visit?” with a space for the response.
    22 Mar 2007
    Amendment 02: The main reasons for this amendment were to include a younger population of participants, specifically pediatric participants aged 12 to 23 months, and to address clarifications requested by investigators and study coordinators. The sample size was increased 1700 participants from 1350 participants. All references and descriptions of study medication were changed to reflect the addition of the oral granule formulation of montelukast and matching placebo that would be used in participants aged 12 to 23 months.
    13 Dec 2007
    Amendment 03: The main reason for this amendment was to include a younger population of participants, specifically those aged 6 to 12 months. Also the updated United States (US) Product Circular and US Patient Product Information were added.

    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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