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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
    2014-004875-21
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    19 Jun 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    P05067
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00453063
    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
    19 Jun 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 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 spay (MFNS) once daily (QD) compared with placebo in subjects 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
    16 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: 426
    Worldwide total number of subjects
    426
    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)
    48
    Adults (18-64 years)
    369
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 426 participants were randomized at 24 study centers in the US to the following treatments: MFNS 200 mcg QD (n=211) and placebo (n=215).

    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

    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 (QD) 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, SCH 032088
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning

    Arm title
    Placebo
    Arm description
    Two sprays in each nostril once daily
    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
    211
    215
    Completed
    208
    212
    Not completed
    3
    3
         Protocol deviation
    1
    -
         Adverse event, non-fatal
    1
    2
         Consent withdrawn by subject
    1
    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 (QD) in the morning. Each spray is equal to 50 mcg.

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

    Reporting group values
    Mometasone Furoate Nasal Spray (MFNS) Placebo Total
    Number of subjects
    211 215 426
    Age categorical
    Units: Subjects
        ≤18 years
    18 30 48
        Between 18 and 65 years
    188 181 369
        ≥65 years
    5 4 9
    Gender categorical
    Units: Subjects
        Female
    140 130 270
        Male
    71 85 156

    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 (QD) in the morning. Each spray is equal to 50 mcg.

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

    Primary: Change from Baseline in the 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 the 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, 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. Participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
    End point type
    Primary
    End point timeframe
    Baseline to Day 15
    End point values
    Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    209 [1]
    213 [2]
    Units: units on a scale
    least squares mean (standard deviation)
        Baseline TNSS
    9.83 ± 1.56
    9.69 ± 1.56
        Change from Baseline in TNSS
    -2.36 ± 2.07
    -1.71 ± 2.07
    Notes
    [1] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    [2] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    Statistical analysis title
    Change from BL in AM NOW TNSS: Day 2-15 average
    Statistical analysis description
    The co-primary statistical comparison of the effects of MFNS in the reduction of TNSS was based on the comparison of MFNS versus placebo in the average AM change from Baseline (BL) in the instantaneous (NOW) scores over Days 2 to 15 at the two-sided alpha = 0.05. Least Squares (LS) means, pooled standard deviation, and 95% Confidence Intervals were obtained from an ANCOVA model with treatment and site effect with baseline TNSS as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    ANCOVA
    Confidence interval
         level
    95%

    Primary: Change from Baseline in the 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 the 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 this scale is 9. Participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
    End point type
    Primary
    End point timeframe
    Baseline to Day 15
    End point values
    Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    209 [3]
    213 [4]
    Units: units on a scale
    least squares mean (standard deviation)
        Baseline TOSS
    7.07 ± 1.54
    7.01 ± 1.54
        Change from Baseline in TOSS
    -1.52 ± 1.59
    -1.36 ± 1.59
    Notes
    [3] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    [4] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    Statistical analysis title
    Change from BL in AM NOW TOSS: Day 2-15 average
    Statistical analysis description
    The co-primary statistical comparison of the effects of MFNS in the reduction of TOSS was based on the comparison of MFNS versus placebo in the average AM change from BL in the instantaneous (NOW) scores over Days 2 to 15 at the two-sided alpha = 0.05. LS means, pooled standard deviation, and 95% Confidence Intervals were obtained from an ANCOVA model with treatment and site effect with baseline TOSS as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.304
    Method
    ANCOVA
    Confidence interval
         level
    95%

    Secondary: Change from Baseline in AM NOW Nasal Congestion Score (NCS) Averaged Over Days 2 to 15

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    End point title
    Change from Baseline in AM NOW Nasal Congestion Score (NCS) 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. Participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 15
    End point values
    Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    209 [5]
    213 [6]
    Units: units on a scale
    least squares mean (standard deviation)
        Baseline Nasal Congestion Score
    2.66 ± 0.4
    2.64 ± 0.4
        Change from Baseline in Nasal Congestion Score
    -0.54 ± 0.54
    -0.39 ± 0.54
    Notes
    [5] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    [6] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    Statistical analysis title
    Change from BL in AM NOW NCS: Day 2-15 average
    Statistical analysis description
    LS means, pooled standard deviation, and 95% Confidence Intervals were obtained from an ANCOVA model with treatment and site effect with baseline Nasal Congestion Score as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004
    Method
    ANCOVA
    Confidence interval
         level
    95%

    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.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 15
    End point values
    Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    189 [7]
    182 [8]
    Units: units on a scale
    least squares mean (standard deviation)
        Baseline RQLQ Total Score
    4.19 ± 0.97
    4.42 ± 0.97
        Change from Baseline in RQLQ Total Score
    -1.63 ± 1.37
    -1.36 ± 1.37
    Notes
    [7] - RQLQ tool only validated in participants ≥18 years of age, so only administered to this age group.
    [8] - RQLQ tool only validated in participants ≥18 years of age, so only administered to this age group.
    Statistical analysis title
    Change from BL in RQLQ at Endpoint
    Statistical analysis description
    LS means, pooled standard deviation, and 95% Confidence Intervals were obtained from an ANCOVA model with treatment and site effect with baseline RQLQ 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
    = 0.063
    Method
    ANCOVA
    Confidence interval
         level
    95%

    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. Participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 15
    End point values
    Mometasone Furoate Nasal Spray (MFNS) Placebo
    Number of subjects analysed
    209 [9]
    213 [10]
    Units: liters/minute
    least squares mean (standard deviation)
        Baseline PNIF
    89.11 ± 37.2
    88.85 ± 37.2
        Change from Baseline in PNIF
    10.15 ± 21.1
    8.24 ± 21.1
    Notes
    [9] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    [10] - All randomized participants were to be included in the analysis (intent-to-treat principle).
    Statistical analysis title
    Change from BL in PNIF: Day 2-15 average
    Statistical analysis description
    LS means, pooled standard deviation, and 95% Confidence Intervals were obtained from an ANCOVA model with treatment and site effect with baseline PNIF as a covariate.
    Comparison groups
    Mometasone Furoate Nasal Spray (MFNS) v Placebo
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.356
    Method
    ANCOVA
    Confidence interval
         level
    95%

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From Day 1 up to 30 days after study completion/discontinuation (up to 45 days total)
    Adverse event reporting additional description
    All randomized participants were to be included in the analysis (intent-to-treat principle).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Two sprays in each nostril once daily

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

    Serious adverse events
    Placebo Mometasone Furoate Nasal Spray (MFNS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 215 (0.00%)
    0 / 211 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Mometasone Furoate Nasal Spray (MFNS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 215 (0.00%)
    0 / 211 (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 adverse events were reported which exceeded the threshold of 5%.

    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
    The primary purpose of Amendment 1 (AM1) was to add TOSS as a co-primary endpoint and add change from baseline in AM PNIF (averaged over Days 2-15) as a key secondary endpoint. AM1 also reduced the planned total enrollment from 500 to 460, designated the Baseline Visit for investigator evaluation, revised inclusion criteria, specified an intent-to treat principle for efficacy analyses, and revised the statistical testing method of the co-primary endpoints.
    28 May 2007
    The primary purpose of AM2 was to add secondary objectives and endpoints for RQLQ and AM NOW nasal congestion, and to clarify AEs and vital signs as Safety endpoints.

    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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