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    Clinical Trial Results:
    Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis

    Summary
    EudraCT number
    		 2014-004925-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Jul 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    P04824
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00423176
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Registration Number: MK-0887-122
    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
    12 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy was based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography [CT] imaging of the sinuses).
    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
    21 Dec 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
    United States: 237
    Worldwide total number of subjects
    237
    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)
    11
    Adults (18-64 years)
    213
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 237 subjects at 65 centers were enrolled, received randomized treatment assignment, and received at least one dose of study medication (MFNS = 114, Placebo = 123).

    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
    		 Placebo
    Arm description
    		 Matching placebo nasal spray twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 1 gm/clavulanic acid 62.5 mg BID, depending on age).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching Placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Placebo, 2 sprays in each nostril BID for 29 days

    Investigational medicinal product name
    amoxicillin/clavulanic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants 12 to 15 years of age: one tablet of amoxicillin 875 mg/clavulanic acid 125 mg BID for 10 days Participants 16 years of age and older: two tablets of amoxicillin 1 gm/clavulanic acid 62.5 mg BID for 10 days

    Arm title
    		 Mometasone furoate nasal spray (MFNS)
    Arm description
    		 MFNS twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 1 gm/clavulanic acid 62.5mg BID for participants 16 years of age or older).
    Arm type
    		 Experimental

    Investigational medicinal product name
    MFNS
    Investigational medicinal product code
    Other name
    MK-0887, SCH 032088, mometasone furoate monohydrate, Nasonex®
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    MFNS 50 mcg/spray, 2 sprays in each nostril BID for 29 days

    Investigational medicinal product name
    amoxicillin/clavulanic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants 12 to 15 years of age: one tablet of amoxicillin 875 mg/clavulanic acid 125 mg BID for 10 days Participants 16 years of age and older: two tablets of amoxicillin 1 gm/clavulanic acid 62.5 mg BID for 10 days

    Number of subjects in period 1
    		Placebo Mometasone furoate nasal spray (MFNS)
    Started
    123
    114
    Completed
    94
    98
    Not completed
    29
    16
         Did not meet protocol eligibility
    4
    2
         Consent withdrawn by subject
    3
    4
         Adverse event, non-fatal
    6
    4
         Treatment Failure
    6
    1
         Lost to follow-up
    7
    4
         Protocol deviation
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone furoate nasal spray (MFNS)
    Reporting group description
    		 MFNS twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 1 gm/clavulanic acid 62.5mg BID for participants 16 years of age or older).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo nasal spray twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 1 gm/clavulanic acid 62.5 mg BID, depending on age).

    Reporting group values
    		 Mometasone furoate nasal spray (MFNS) Placebo Total
    Number of subjects
    		 114 123 237
    Age Categorical
    Units: participants
        <=18 years
    		 5 6 11
        Between 18 and 65 years
    		 106 107 213
        >=65 years
    		 3 10 13
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.3 ( 13.2 ) 39 ( 14.9 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 80 72 152
        Male
    		 34 51 85

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo nasal spray twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 1 gm/clavulanic acid 62.5 mg BID, depending on age).

    Reporting group title
    Mometasone furoate nasal spray (MFNS)
    Reporting group description
    		 MFNS twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 1 gm/clavulanic acid 62.5mg BID for participants 16 years of age or older).

    Primary: Baseline change in AM/PM PRIOR Major Symptoms Score (MSS) minus sinus headache averaged over Days 1 to 29

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    End point title
    		 Baseline change in AM/PM PRIOR Major Symptoms Score (MSS) minus sinus headache averaged over Days 1 to 29
    End point description
    The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the participant's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following participant-evaluated symptoms: facial pain/pressure/tenderness, sinus headache (excluded), purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion. MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom, range is 0 to 12. All randomized participants with both Baseline and postbaseline values were analyzed.
    End point type
    Primary
    End point timeframe
    29-day Treatment Period and 2-week no-treatment Follow-up Period (f/u)
    End point values
    		 Mometasone furoate nasal spray (MFNS) Placebo
    Number of subjects analysed
    105 [1]
    116 [2]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    8.57 ( 1.78 )
    8.78 ( 2.03 )
        Days 1-29
    -4.9 ( 2.69 )
    -4.46 ( 2.54 )
        Days 30-43 (follow-up)
    -6.59 ( 2.81 )
    -5.77 ( 2.98 )
    Notes
    [1] - Days 1-29, n=105 Days 30-43 (f/u), n=96
    [2] - Days 1-29, n=116 Days 30-43 (f/u), n=97
    Statistical analysis title
    		 Change from BL in MSS: Days 1-29 average
    Statistical analysis description
    ANCOVA was not performed as prespecified in the protocol due to early termination of the study. Means, standard deviations (SD) and 95% confidence intervals (CI) were based on summaries without adjusting for model covariates.
    Comparison groups
    Mometasone furoate nasal spray (MFNS) v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.14
         upper limit
    		 0.25
    Statistical analysis title
    		 Change from BL in MSS: Days 30-43 average
    Statistical analysis description
    ANCOVA was not performed as prespecified in the protocol due to early termination of the study. Means, standard deviations (SD) and 95% confidence intervals (CI) were based on summaries without adjusting for model covariates.
    Comparison groups
    Mometasone furoate nasal spray (MFNS) v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 0

    Primary: Change from Baseline to Endpoint in percent of opacification of the maxillary sinus that had the maximum opacification score at Baseline

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    End point title
    		 Change from Baseline to Endpoint in percent of opacification of the maxillary sinus that had the maximum opacification score at Baseline
    End point description
    A coronal computerized tomography was obtained to visualize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported. All randomized participants with both Baseline and postbaseline values were analyzed. Endpoint was defined as the last treatment visit.
    End point type
    Primary
    End point timeframe
    29-day Treatment Period and 2-week no-treatment Follow-up Period
    End point values
    		 Mometasone furoate nasal spray (MFNS) Placebo
    Number of subjects analysed
    99
    103
    Units: Percentage of opacification
    arithmetic mean (standard deviation)
        Baseline
    50.7 ( 30.4 )
    56.8 ( 31.7 )
        Change from Baseline at Endpoint
    -23.7 ( 35.2 )
    -32.5 ( 32 )
    Statistical analysis title
    		 Change from BL in % of Opacification of MS
    Statistical analysis description
    ANCOVA was not performed as prespecified in the protocol due to early termination of the study. Means, standard deviations (SD) and 95% confidence intervals (CI) were based on summaries without adjusting for model covariates.
    Comparison groups
    Mometasone furoate nasal spray (MFNS) v Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 18.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 up to Day 43
    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
    11.1
    Reporting groups
    Reporting group title
    Mometasone Furoate Nasal Spray (MFNS)
    Reporting group description
    		 MFNS twice daily (BID) for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 1 gm/clavulanic acid 62.5mg BID for participants 16 years of age or older).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo nasal spray BID for 29 days, plus antibiotic for the first 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 1 gm/clavulanic acid 62.5mg BID, depending on age).

    Serious adverse events
    		 Mometasone Furoate Nasal Spray (MFNS) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 123 (0.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Neck Pain
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    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
    22 / 114 (19.30%)
    17 / 123 (13.82%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 114 (5.26%)
    1 / 123 (0.81%)
         occurrences all number
    7
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    17 / 114 (14.91%)
    14 / 123 (11.38%)
         occurrences all number
    19
    14
    Infections and infestations
    Fungal Infection
         subjects affected / exposed
    6 / 114 (5.26%)
    3 / 123 (2.44%)
         occurrences all number
    6
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2006
    Amendment 1 (AM1) increased the treatment period from 15 to 29 days, added a co-primary endpoint of change in percent of opacification of the maxillary sinus and revised the primary objective accordingly, revised the secondary endpoints, revised eligibility criteria, and revised the statistical sections to reflect the new co-primary endpoint.
    08 Mar 2007
    AM2 added ~20 additional study centers, added a new treatment assessment scale (Overall Treatment Effect Scale), revised eligibility criteria, clarified some study procedures, and added a subanalysis.
    02 Nov 2007
    AM3 increased the number of study centers to 120 and revised a screening/eligibility criterion.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Jul 2008
    The study was terminated by the sponsor before the planned enrollment of 600 subjects was completed; total enrollment was 237 participants. The decision to terminate the study early was based on business priorities and slower than anticipated enrollment of participants. Study termination was not related to any safety issue and took place before any data were unblinded or analyzed.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early due to a very high screening failure rate (mainly caused by the necessity to demonstrate CT changes at baseline indicative of acute sinusitis), which limits any conclusions.
    For support, Contact us.
    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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