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    Clinical Trial Results:
    Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

    Summary
    EudraCT number
    		 2014-004923-40
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    30 Sep 2009

    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
    P04367 - Lebanon
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01098071
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Registration Number: MK-0887-096
    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
    30 Sep 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To document the short term & long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae).
    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
    01 May 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
    Lebanon: 34
    Worldwide total number of subjects
    34
    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)
    2
    Children (2-11 years)
    32
    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
    		 34 participants enrolled in the study, 19 completed treatment and follow-up, and 15 patients discontinued the study.

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

    Arms
    Arm title
    		 Mometasone furoate nasal spray
    Arm description
    		 One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone Furoate nasal spray
    Investigational medicinal product code
    Other name
    Nasonex®, MK-0887, SCH 032088
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months. After initial priming, each actuation of the pump delivers a metered spray containing 100 mcg of suspension (50 mcg mometasone furoate monohydrate).

    Number of subjects in period 1
    		Mometasone furoate nasal spray
    Started
    34
    Completed
    19
    Not completed
    15
         Lost to follow-up
    13
         Surgery (adenoidectomy)
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

    Reporting group values
    		 Mometasone furoate nasal spray Total
    Number of subjects
    		 34 34
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (full range (min-max))
    		 4.84 (0.5 to 9.25) -
    Gender, Male/Female
    Units: participants
        Female
    		 15 15
        Male
    		 19 19
    Region of Enrollment
    Units: Subjects
        Lebanon
    		 34 34

    End points

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    End points reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

    Primary: Severity of nasal obstruction symptoms at Baseline and Week 12 as measured by the total clinical score

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    End point title
    		 Severity of nasal obstruction symptoms at Baseline and Week 12 as measured by the total clinical score [1]
    End point description
    Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]). Only participants who completed the study were included in this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12 (Visit 2)
    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 between-group statistical analyses were performed for this endpoint.
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    19
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Baseline score
    3.89 (2 to 5)
        Score at Week 12
    1.26 (0 to 4)
    No statistical analyses for this end point

    Primary: Number of participants referred to surgery (adenoidectomy) within 12 weeks of start of therapy

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    End point title
    		 Number of participants referred to surgery (adenoidectomy) within 12 weeks of start of therapy [2]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 12 weeks (Visit 2)
    Notes
    [2] - 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 between-group statistical analyses were performed for this endpoint.
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    19
    Units: Participants
        number (not applicable)
    2
    No statistical analyses for this end point

    Primary: Degree of posterior choana obstruction at Baseline and Week 12

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    End point title
    		 Degree of posterior choana obstruction at Baseline and Week 12 [3]
    End point description
    The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II, and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12 (Visit 2)
    Notes
    [3] - 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 between-group statistical analyses were performed for this endpoint.
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    19
    Units: Percent obstruction
    arithmetic mean (full range (min-max))
        Baseline score
    85 (70 to 95)
        Score at Week 12
    61 (40 to 80)
    No statistical analyses for this end point

    Secondary: Severity of rhinorrhea at Baseline and Week 12

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    End point title
    		 Severity of rhinorrhea at Baseline and Week 12
    End point description
    Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]) in participants with suspected allergic rhinitis at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12 (Visit 2)
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    10
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Baseline score
    0.95 (0 to 3)
        Score at Week 12
    0.37 (0 to 2)
    No statistical analyses for this end point

    Secondary: Severity of nasal congestion at Baseline and Week 12

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    End point title
    		 Severity of nasal congestion at Baseline and Week 12
    End point description
    Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]) in participants with suspected allergic rhinitis at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    10
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Baseline score
    0.79 (0 to 3)
        Score at Week 12
    0.32 (0 to 3)
    No statistical analyses for this end point

    Secondary: Severity of nasal itching at Baseline and Week 12

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    End point title
    		 Severity of nasal itching at Baseline and Week 12
    End point description
    Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]) in participants with suspected allergic rhinitis at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    10
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Baseline score
    0.74 (0 to 3)
        Score at Week 12
    0.37 (0 to 1)
    No statistical analyses for this end point

    Secondary: Severity of sneezing at Baseline and Week 12

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    End point title
    		 Severity of sneezing at Baseline and Week 12
    End point description
    Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]) in participants with suspected allergic rhinitis at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    10
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Baseline score
    0.89 (0 to 3)
        Score at Week 12
    0.37 (0 to 2)
    No statistical analyses for this end point

    Secondary: Severity of eye symptoms at Baseline and Week 12

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    End point title
    		 Severity of eye symptoms at Baseline and Week 12
    End point description
    Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]) in participants with suspected allergic rhinitis at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Mometasone furoate nasal spray
    Number of subjects analysed
    10
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Baseline score
    0.68 (0 to 3)
        Score at Week 12
    0.16 (0 to 1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From Screening visit up to 30 days after completion or discontinuation from study (up to 15 months)
    Adverse event reporting additional description
    In this study, symptoms of allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing, and eye symptoms) were not reported as adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

    Serious adverse events
    		 Mometasone furoate nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Mometasone furoate nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AEs were reported during the course of the study.

    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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