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

    Summary
    EudraCT number
    		 2014-004916-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Jul 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    P05106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00468312
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-0887-135, Merck Protocol Number: P05106
    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
    20 Jul 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jul 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to assess the efficacy of mometasone furoate nasal spray (MFNS) once daily compared with placebo in participants with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score (TNSS) and the total ocular symptom score (TOSS).
    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
    22 Mar 2007
    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: 429
    Worldwide total number of subjects
    429
    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)
    1
    Adolescents (12-17 years)
    55
    Adults (18-64 years)
    365
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants 12 years of age and older with at least a 2-year documented history of SAR which exacerbated during the study season of SAR were selected for this study.

    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 (MFNS)
    Arm description
    		 MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mometasone furoate
    Investigational medicinal product code
    Other name
    Nasonex, MK-0887, SCH 032088
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Two sprays in each nostril once daily in the morning

    Arm title
    		 Placebo
    Arm description
    		 Two sprays in each nostril once daily in the morning
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Two sprays in each nostril once daily in the morning

    Number of subjects in period 1
    		Mometasone Furoate Nasal Spray (MFNS) Placebo
    Started
    220
    209
    Completed
    216
    204
    Not completed
    4
    5
         Did not meet protocol eligibility
    -
    1
         Adverse event, non-fatal
    2
    1
         Protocol deviation
    2
    1
         Lack of efficacy
    -
    1
         Withdrawal by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone Furoate Nasal Spray (MFNS)
    Reporting group description
    		 MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.

    Reporting group title
    Placebo
    Reporting group description
    		 Two sprays in each nostril once daily in the morning

    Reporting group values
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo Total
    Number of subjects
    		 220 209 429
    Age categorical
    Units: Subjects
        6 to <12 years
    		 0 1 1
        12 to <18 years
    		 31 24 55
        18 to <65 years
    		 184 181 365
        ≥65 years
    		 5 3 8
    Gender categorical
    Units: Subjects
        Female
    		 132 125 257
        Male
    		 88 84 172

    End points

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    End points reporting groups
    Reporting group title
    Mometasone Furoate Nasal Spray (MFNS)
    Reporting group description
    		 MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.

    Reporting group title
    Placebo
    Reporting group description
    		 Two sprays in each nostril once daily in the morning

    Primary: Change from Baseline in average AM instantaneous (NOW) Total Nasal Symptom Score (TNSS) averaged over Days 2 to 15

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    End point title
    		 Change from Baseline in average AM instantaneous (NOW) Total Nasal Symptom Score (TNSS) averaged over Days 2 to 15
    End point description
    TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
    End point type
    Primary
    End point timeframe
    Baseline and Days 2 through 15
    End point values
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    220 [1]
    208 [2]
    Units: Score on a scale
    least squares mean (standard deviation)
        Baseline TNSS
    9.31 ± 1.6
    9.31 ± 1.6
        Change from Baseline in TNSS
    -2.54 ± 1.99
    -1.66 ± 1.99
    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
    		 Change in AM NOW TNSS: MFNS vs. Placebo
    Statistical analysis description
    Difference in Least Square (LS) means for average change from Baseline over Days 2 to 15 in AM NOW TNSS: MFNS 200 mcg vs. Placebo. LS means, pooled standard deviation, and 95% Confidence Intervals are obtained from an analysis of covariance (ANCOVA) model with treatment and site effect with baseline score as a covariate.
    Comparison groups
    Placebo v Mometasone Furoate Nasal Spray (MFNS)
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 -0.51

    Primary: Change from Baseline in average AM instantaneous (NOW) Total Ocular Symptom Score (TOSS) averaged over Days 2 to 15

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    End point title
    		 Change from Baseline in average AM instantaneous (NOW) Total Ocular Symptom Score (TOSS) averaged over Days 2 to 15
    End point description
    TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.
    End point type
    Primary
    End point timeframe
    Baseline and Days 2 through 15
    End point values
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    220 [3]
    208 [4]
    Units: Score on a scale
    least squares mean (standard deviation)
        Baseline TOSS
    6.78 ± 1.46
    6.74 ± 1.46
        Change from Baseline in TOSS
    -1.71 ± 1.6
    -1.37 ± 1.6
    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
    		 Change in AM NOW TOSS: MFNS vs. Placebo
    Statistical analysis description
    Difference in Least Square (LS) means for average change from Baseline over Days 2 to 15 in AM NOW TOSS: MFNS 200 mcg vs. Placebo. LS means, pooled standard deviation, and 95% Confident Intervals are obtained from an analysis of covariance (ANCOVA) model with treatment and site effect with baseline score as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.026
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.65
         upper limit
    		 -0.04

    Secondary: Change from Baseline in AM NOW nasal congestion score averaged over Days 2 to 15

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    End point title
    		 Change from Baseline in AM NOW nasal congestion score averaged over Days 2 to 15
    End point description
    Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 2 through 15
    End point values
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    220 [5]
    208 [6]
    Units: Score on a scale
    least squares mean (standard deviation)
        Baseline Nasal Congestion Score
    2.6 ± 0.38
    2.62 ± 0.38
        Change from Baseline in Nasal Congestion Score
    -0.59 ± 0.53
    -0.39 ± 0.53
    Notes
    [5] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [6] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    Statistical analysis title
    		 Change in AM NOW Nasal Congestion Score
    Statistical analysis description
    Difference in Least Square (LS) means for average change from Baseline over Days 2 to 15 in AM NOW Nasal Congestion Score: MFNS 200 mcg vs. Placebo. LS means, pooled standard deviation, and 95% Confidence Intervals are obtained from an analysis of covariance (ANCOVA) model with treatment and site effect with baseline score as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 -0.1

    Secondary: Change from Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)

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    End point title
    		 Change from Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
    End point description
    The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    189 [7]
    182 [8]
    Units: Score on a scale
    least squares mean (standard deviation)
        Baseline RQLQ Total Score
    4.27 ± 1.01
    4.28 ± 1.01
        Change from Baseline in RQLQ Total Score
    -1.81 ± 1.36
    -1.08 ± 1.36
    Notes
    [7] - The RQLQ tool is only validated in participants greater than 18 years of age.
    [8] - The RQLQ tool is only validated in participants greater than 18 years of age.
    Statistical analysis title
    		 Change in RQLQ: MFNS vs. Placebo
    Statistical analysis description
    Change in Least Square (LS) means for average change from Baseline over Days 2 to 15 in RQLQ total score: MFNS 200 mcg vs. Placebo. LS means, pooled standard deviation, and 95% Confidence Intervals are obtained from an analysis of covariance (ANCOVA) model with treatment and site effects with baseline score as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 -0.45

    Secondary: Change from Baseline in AM Peak Nasal Inspiratory Flow (PNIF) averaged over Days 2 to 15

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    End point title
    		 Change from Baseline in AM Peak Nasal Inspiratory Flow (PNIF) averaged over Days 2 to 15
    End point description
    Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 2 through 15
    End point values
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    220 [9]
    208 [10]
    Units: liters/minute
    least squares mean (standard deviation)
        Baseline PNIF
    93.12 ± 41.3
    91.96 ± 41.3
        Change from Baseline in PNIF
    16.55 ± 36.9
    12.59 ± 36.9
    Notes
    [9] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [10] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    Statistical analysis title
    		 Change in PNIF: MFNS vs. Placebo
    Statistical analysis description
    Difference in Least Square (LS) means for average change from Baseline from Days 2 to 15 in PNIF: MFNS 200 mcg vs. Placebo. LS means, pooled standard deviation, and 95% Confidence Intervals are obtained from an analysis of covariance (ANCOVA) model with treatment and site effect with baseline score as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.269
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.07
         upper limit
    		 10.98

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 45 days (including up to 30 days following last dose for serious adverse events)
    Adverse event reporting additional description
    The safety population consisted of all randomized participants who received ≥1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Mometasone Furoate Nasal Spray (MFNS)
    Reporting group description
    		 MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.

    Reporting group title
    Placebo
    Reporting group description
    		 Two sprays in each nostril once daily in the morning

    Serious adverse events
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 209 (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 (MFNS) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 209 (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? Yes
    Date
    Amendment
    08 Mar 2007
    Primary reason for amendment was to incorporate revisions to primary endpoint from assessing total symptom score (TSS) to assessing total nasal symptom score (TNSS) and total ocular symptom score (TOSS).
    28 May 2007
    Primary reason for amendment was to add secondary objectives to assess the efficacy of MFNS in improving congestion, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and AM peak nasal inspiratory flow.

    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
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