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    Clinical Trial Results:
    Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)

    Summary
    EudraCT number
    		 2014-004918-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Oct 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    13 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P05528
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00733005
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck, Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck, Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis (SAR). The primary hypothesis is that Mometasone Furoate Nasal Spray (MFNS) is more effective than placebo in reducing the AM/PM PRIOR nasal congestion.
    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
    28 Jul 2008
    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
    United States: 324
    Worldwide total number of subjects
    324
    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)
    0
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    302
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants screened for this study were 12 years of age or older, had at least a 2-year history of seasonal allergic rhinitis (SAR) which exacerbates during the study season, and were clinically symptomatic at the Screening and Baseline visits.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mometasone furoate nasal spray
    Arm description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)
    Arm type
    		 Experimental

    Investigational medicinal product name
    mometasone furoate nasal spray (MFNS)
    Investigational medicinal product code
    Other name
    Nasonex, MK-0887, SCH 032088
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days

    Arm title
    		 Placebo nasal spray
    Arm description
    		 Matching placebo nasal spray
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

    Number of subjects in period 1
    		Mometasone furoate nasal spray Placebo nasal spray
    Started
    162
    162
    Completed
    160
    159
    Not completed
    2
    3
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    1
         Treatment Failure
    -
    1
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 Matching placebo nasal spray

    Reporting group values
    		 Mometasone furoate nasal spray Placebo nasal spray Total
    Number of subjects
    		 162 162 324
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 7 8 15
        Adults (between 18 and 64 years)
    		 148 154 302
        From 65 to 84 years
    		 7 0 7
    Gender categorical
    Units: Subjects
        Female
    		 113 116 229
        Male
    		 49 46 95

    End points

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    End points reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 Matching placebo nasal spray

    Primary: The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days.

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    End point title
    		 The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days.
    End point description
    Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the participant's status over the previous 12 hours [reflective]). A change from baseline score that is negative indicates an improvement in condition.
    End point type
    Primary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Mometasone furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    162 [1]
    162 [2]
    Units: Units on a scale
        least squares mean (standard deviation)
    -0.68 ± 0.59
    -0.57 ± 0.59
    Notes
    [1] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [2] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    Statistical analysis title
    		 AM/PM PRIOR Nasal Congestion
    Statistical analysis description
    LS means, Pstd (pooled std), and 95% Confidence Intervals are obtained from an ANCOVA model with treatment (trt) and site effect with baseline score as a covariate.
    Comparison groups
    Mometasone furoate nasal spray v Placebo nasal spray
    Number of subjects included in analysis
    324
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.102
    Method
    		 ANCOVA
    Confidence interval

    Secondary: The change from Baseline in average AM/PM PRIOR total nasal symptom score over 15 days

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    End point title
    		 The change from Baseline in average AM/PM PRIOR total nasal symptom score over 15 days
    End point description
    Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12 and a higher score indicating more severe nasal symptoms. A change from baseline score that is negative indicates an improvement in condition.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Mometasone furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    162 [3]
    162 [4]
    Units: Units on a scale
        least squares mean (standard deviation)
    -2.61 ± 2.1
    -2.06 ± 2.1
    Notes
    [3] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [4] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    Statistical analysis title
    		 AM/PM PRIOR Total Nasal Symptom Score
    Statistical analysis description
    LS means, Pstd (pooled std), and 95% Confidence Intervals are obtained from an ANCOVA model with treatment (trt) and site effect with baseline score as a covariate.
    Comparison groups
    Mometasone furoate nasal spray v Placebo nasal spray
    Number of subjects included in analysis
    324
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 18
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 Matching placebo nasal spray

    Serious adverse events
    		 Mometasone furoate nasal spray Placebo nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 162 (0.00%)
    0 / 162 (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
    		 Mometasone furoate nasal spray Placebo nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 162 (0.00%)
    0 / 162 (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 non-serious adverse events exceeded the 5% threshold for any reporting group.

    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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