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    Clinical Trial Results:
    A study of long-term (12-24 weeks) administration of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis (Protocol No. P06333)

    Summary
    EudraCT number
    		 2014-004922-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Dec 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    15 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P06333
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01165424
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: MK-0887-175
    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
    28 Dec 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric participants (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Participants (participant's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
    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
    08 Apr 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: 80
    Worldwide total number of subjects
    80
    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)
    56
    Adolescents (12-17 years)
    24
    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 at 7 clinical sites in Japan.

    Pre-assignment
    Screening details
    		 Ninety-eight participants were tentatively enrolled after giving consent. Of these, 80 who satisfied the eligibility criteria after the pretreatment observation period of at least 7 days were registered.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Mometasone furoate nasal spray
    Arm description
    		 Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone furoate nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks.

    Number of subjects in period 1
    		Mometasone furoate nasal spray
    Started
    80
    Completed
    76
    Not completed
    4
         Adverse event, non-fatal
    1
         'Laboratory adverse event '
    1
         Met discontinuation criteria
    1
         Moved (relocation)
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks.

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 80 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 56 56
        Adolescents (12-17 years)
    		 24 24
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.2 ± 3.4 -
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 54 54

    End points

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    End points reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks.

    Primary: Number of Participants With Adverse Events and Adverse Drug Reactions

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    End point title
    		 Number of Participants With Adverse Events and Adverse Drug Reactions [1]
    End point description
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse drug reactions are all noxious and unintended responses to a medicinal product related to any dose.
    End point type
    Primary
    End point timeframe
    Up to 28 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed with this primary endpoint as there was only a single study arm and the data was in the form of number of participants with no statistical analysis.
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    80
    Units: Participants
        Number with Adverse Events
    76
        Number with Adverse Drug Reactions
    18
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Total Nasal Symptom Score

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    End point title
    		 Change From Baseline in the Total Nasal Symptom Score
    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, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 (or discontinuation)
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    80
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2, N=80
    -3.1 ± 0.3
        Week 4, N=79
    -3.9 ± 0.3
        Week 8, N=79
    -4.4 ± 0.3
        Week 12, N=77
    -4.5 ± 0.3
        Week 16, N=72
    -4.9 ± 0.3
        Week 20, N=70
    -5 ± 0.3
        Week 24, N=69
    -4.8 ± 0.3
        Week 24 or discontinuation, N=80
    -4.9 ± 0.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 214 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. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks.

    Serious adverse events
    		 MFNS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 80 (1.25%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MFNS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 80 (90.00%)
    Investigations
    Blood cortisol decreased
         subjects affected / exposed
    27 / 80 (33.75%)
         occurrences all number
    30
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    17
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    12
    Epistaxis
         subjects affected / exposed
    24 / 80 (30.00%)
         occurrences all number
    69
    Skin and subcutaneous tissue disorders
    Heat rash
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    15
    Acute tonsillitis
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    8
    Bronchitis
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    17
    Nasopharyngitis
         subjects affected / exposed
    41 / 80 (51.25%)
         occurrences all number
    73
    Pharyngitis
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    12
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6

    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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    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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