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    Clinical Trial Results:
    Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis (P06332)

    Summary
    EudraCT number
    		 2014-004921-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Oct 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    P06332
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01135134
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: MK-0887-174
    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
    15 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric participants with perennial allergic rhinitis. Participants 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible participants will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jun 2010
    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
    Japan: 333
    Worldwide total number of subjects
    333
    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)
    220
    Adolescents (12-17 years)
    113
    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
    		 This study was performed in 19 clinical sites in Japan.

    Pre-assignment
    Screening details
    		 Male or female outpatients (5 to 15 years) with symptoms of perennial allergic rhinitis of moderate to severe degree (classification of severity in the Practical Guideline for the Management of Allergic Rhinitis in Japan) as well as a total score of at least 4 for nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching)

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mometasone furoate nasal spray (MFNS) (50 μg spray)
    Arm description
    		 MFNS, 50 μg spray device. The dose will be as follows: for ages 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks and for ages 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone furoate nasal spray (MFNS) (50 μg spray)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    MFNS, 50 μg spray device. The dose will be as follows: for ages 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks and for ages 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo Comparator: MF placebo nasal spray, administration will be as follows: for subjects ages 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks and for subjects ages 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo Comparator: MF placebo nasal spray, administration will be as follows: for subjects ages 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks and for subjects ages 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.

    Number of subjects in period 1
    		Mometasone furoate nasal spray (MFNS) (50 μg spray) Placebo
    Started
    220
    113
    Completed
    218
    112
    Not completed
    2
    1
         Adverse event, non-fatal
    1
    1
         Met discontinuation criteria
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone furoate nasal spray (MFNS) (50 μg spray)
    Reporting group description
    		 MFNS, 50 μg spray device. The dose will be as follows: for ages 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks and for ages 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Comparator: MF placebo nasal spray, administration will be as follows: for subjects ages 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks and for subjects ages 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.

    Reporting group values
    		 Mometasone furoate nasal spray (MFNS) (50 μg spray) Placebo Total
    Number of subjects
    		 220 113 333
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 146 74 220
        Adolescents (12-17 years)
    		 74 39 113
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.7 ( 2.9 ) 9.8 ( 2.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 90 38 128
        Male
    		 130 75 205

    End points

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    End points reporting groups
    Reporting group title
    Mometasone furoate nasal spray (MFNS) (50 μg spray)
    Reporting group description
    		 MFNS, 50 μg spray device. The dose will be as follows: for ages 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks and for ages 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Comparator: MF placebo nasal spray, administration will be as follows: for subjects ages 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks and for subjects ages 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.

    Primary: Change From Baseline in the Total Nasal Symptom Score at 2 Weeks

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    End point title
    		 Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
    End point description
    Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12 with higher scores reflecting more severe symptoms.
    End point type
    Primary
    End point timeframe
    Baseline and 2 weeks (or discontinuation)
    End point values
    		 Mometasone furoate nasal spray (MFNS) (50 μg spray) Placebo
    Number of subjects analysed
    220
    113
    Units: Scores on a scale
        least squares mean (standard error)
    -3.985 ( 0.1633 )
    -1.9081 ( 0.2233 )
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Least squares mean change from baseline for Total Nasal Symptom Score at 2 Weeks for MFNS minus least squares mean change from baseline for Total Nasal Symptom Score at 2 Weeks for placebo
    Comparison groups
    Mometasone furoate nasal spray (MFNS) (50 μg spray) v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.0769
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6079
         upper limit
    		 -1.5459
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2699
    Notes
    [1] - An analysis of covariance (ANCOVA) method was performed for the change of total score of 4 nasal symptom scores at 2 weeks (or at the end of the study). The model included variables of baseline total nasal score as covariate, and age strata (5-11 years, 12-15 years) and treatment group as fixed effects.

    Secondary: Change From Baseline in the Total Nasal Symptom Score at 1 Week

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    End point title
    		 Change From Baseline in the Total Nasal Symptom Score at 1 Week
    End point description
    Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12 with a higher score reflecting more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 week
    End point values
    		 Mometasone furoate nasal spray (MFNS) (50 μg spray) Placebo
    Number of subjects analysed
    219
    113
    Units: Score on a scale
        least squares mean (standard error)
    -2.4686 ( 0.1441 )
    -1.1651 ( 0.1967 )
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Least squares mean change from baseline for Total Nasal Symptom Score at 1 Week for MFNS minus least squares mean change from baseline for Total Nasal Symptom Score at 1 Week for placebo
    Comparison groups
    Placebo v Mometasone furoate nasal spray (MFNS) (50 μg spray)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -1.3035
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7716
         upper limit
    		 -0.8355
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2379
    Notes
    [2] - Change of total score of 4 nasal symptom score at Week 1, using pooled variance calculated by the ANCOVA model with baseline total score as covariate and treatment group and age stratum as fixed effects, the 2-sided 95% confidence interval of the difference (MF – MF placebo) were calculated.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 44 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    MFNS
    Reporting group description
    		 MFNS, 50 μg spray device. The dose will be as follows: for ages 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks and for ages 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks. This 44-day analysis period includes a 14-day Treatment period and a 30-day follow-up period.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Comparator: MF placebo nasal spray, administration will be as follows: for subjects ages 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks and for subjects ages 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks. This 44-day analysis period includes a 14-day Treatment period and a 30-day Follow-up period.

    Serious adverse events
    		 MFNS Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 113 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MFNS Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 220 (10.91%)
    19 / 113 (16.81%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    13 / 220 (5.91%)
    11 / 113 (9.73%)
         occurrences all number
    15
    16
    Infections and infestations
    Naspharyngitis
         subjects affected / exposed
    11 / 220 (5.00%)
    10 / 113 (8.85%)
         occurrences all number
    11
    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.
    None reported
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