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    Clinical Trial Results:
    A Double-blind Placebo-controlled, Randomized, Parallel-group, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study

    Summary
    EudraCT number
    		 2014-004917-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Jan 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Mar 2016
    First version publication date
    29 Jul 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    P05155
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00552032
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-0887-138
    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
    25 Jan 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in children.
    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
    31 Aug 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
    Mexico: 125
    Country: Number of subjects enrolled
    Venezuela, Bolivarian Republic of: 7
    Worldwide total number of subjects
    132
    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)
    132
    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
    		 This study enrolled children aged 2 to 11 years with adenoid hypertrophy (AH) with or without otitis media effusion (OME).

    Pre-assignment
    Screening details
    		 135 participants were screened, of those, 132 were randomized in the intent-to-treat (ITT) population (MFNS n=66, placebo=66) and 96 in the per protocol (PP) population (MFNS n=49, placebo n=47).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mometasone Furoate nasal spray
    Arm description
    		 1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    mometasone furoate
    Investigational medicinal product code
    Other name
    Nasonex, SCH 032088, MK-0887
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Arm title
    		 Placebo nasal spray
    Arm description
    		 1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
    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
    1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Number of subjects in period 1
    		Mometasone Furoate nasal spray Placebo nasal spray
    Started
    66
    66
    Completed
    49
    47
    Not completed
    17
    19
         Consent withdrawn by subject
    2
    2
         Lost to follow-up
    8
    5
         Protocol deviation
    7
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone Furoate nasal spray
    Reporting group description
    		 1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Reporting group values
    		 Mometasone Furoate nasal spray Placebo nasal spray Total
    Number of subjects
    		 66 66 132
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.56 ( 2.27 ) 5.36 ( 2.5 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 32 23 55
        Male
    		 34 43 77
    Adenoid/Choana (A/C) Index Grade
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    		 3.3 ( 0.44 ) 3.4 ( 0.49 ) -

    End points

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    End points reporting groups
    Reporting group title
    Mometasone Furoate nasal spray
    Reporting group description
    		 1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Primary: Change From Baseline in Adenoid/Choana (A/C) Index Grade

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    End point title
    		 Change From Baseline in Adenoid/Choana (A/C) Index Grade
    End point description
    Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.
    End point type
    Primary
    End point timeframe
    Baseline (visit 2), Week 4 (visit 3), Week 8 (visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    65 [1]
    63 [2]
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Visit 3 (n=65 MFNS, n=63 Placebo)
    0.3 ( 0.6 )
    0.2 ( 0.5 )
        Change at Visit 4 (n=61 MFNS, n=58 Placebo)
    0.4 ( 0.7 )
    0.3 ( 0.7 )
    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 from Baseline to Visit 5
    Comparison groups
    Mometasone Furoate nasal spray v Placebo nasal spray
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.23

    Secondary: Total Severity Symptom Scores: Morning and Evening (AM & PM)

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    End point title
    		 Total Severity Symptom Scores: Morning and Evening (AM & PM)
    End point description
    Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3) and PM.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [3]
    66 [4]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 2 AM (n=66 MFNS, n=66 Placebo)
    9.4 ( 2.5 )
    9.9 ( 3.3 )
        Visit 3 AM (n=64 MFNS, n=65 Placebo)
    5.4 ( 3.8 )
    6.4 ( 3.7 )
        Visit 4 AM (n=62 MFNS, n=60 Placebo)
    4.2 ( 3.6 )
    5.5 ( 3.5 )
        Visit 2 PM (n=66 MFNS, n=66 Placebo)
    9.9 ( 3.2 )
    10.2 ( 2.8 )
        Visit 3 PM (n=64 MFNS, n=65 Placebo)
    6.3 ( 3.7 )
    7 ( 3.6 )
        Visit 4 PM (n=62 MFNS, n=60 Placebo)
    4.8 ( 3.8 )
    5.7 ( 3.8 )
    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.
    No statistical analyses for this end point

    Secondary: Total Frequency Symptom Scores: AM & PM

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    End point title
    		 Total Frequency Symptom Scores: AM & PM
    End point description
    Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [5]
    66 [6]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 2 AM (n=66 MFNS, n=66 Placebo)
    7.3 ( 1.9 )
    7.3 ( 2.4 )
        Visit 3 AM (n=64 MFNS, n=65 Placebo)
    4.4 ( 2.7 )
    5.4 ( 2.6 )
        Visit 4 AM (n=62 MFNS, n=60 Placebo)
    3.7 ( 2.8 )
    4.4 ( 2.5 )
        Visit 2 PM (n=66 MFNS, n=66 Placebo)
    7.6 ( 2.2 )
    8 ( 2.1 )
        Visit 3 PM (n=64 MFNS, n=65 Placebo)
    5.3 ( 2.8 )
    5.7 ( 2.6 )
        Visit 4 PM (n=62 MFNS, n=60 Placebo)
    4.1 ( 2.9 )
    4.6 ( 2.7 )
    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.
    No statistical analyses for this end point

    Secondary: Number of Participants with Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done

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    End point title
    		 Number of Participants with Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
    End point description
    Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones), abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [7]
    66 [8]
    Units: Participants
    number (not applicable)
        Visit 2- Normal (n=66 MFNS, n=66 Placebo)
    35
    39
        Visit 2- Abnormal (n=66 MFNS, n=66 Placebo)
    25
    22
        Visit 2- Not Done (n=66 MFNS, n=66 Placebo)
    6
    5
        Visit 3- Normal (n=65 MFNS, n=65 Placebo)
    44
    33
        Visit 3- Abnormal (n=65 MFNS, n=65 Placebo)
    14
    22
        Visit 3- Not Done (n=65 MFNS, n=65 Placebo)
    7
    10
        Visit 4- Normal (n=62 MFNS, n=60 Placebo)
    45
    39
        Visit 4- Abnormal (n=62 MFNS, n=60 Placebo)
    16
    19
        Visit 4- Not Done (n=62 MFNS, n=60 Placebo)
    1
    2
    Notes
    [7] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [8] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants With Otoscopic Results of: Normal or Abnormal

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    End point title
    		 Number of Participants With Otoscopic Results of: Normal or Abnormal
    End point description
    Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [9]
    66 [10]
    Units: Participants
    number (not applicable)
        Right Otoscopy: Visit 2- Normal (n=66, n=66)
    50
    51
        Right Otoscopy: Visit 2- Abnormal (n=66, n=66)
    16
    15
        Right Otoscopy Visit 3- Normal (n=65, n=65)
    54
    53
        Right Otoscopy Visit 3- Abnormal (n=65, n=65)
    11
    12
        Right Otoscopy Visit 4- Normal (n=62, n=60)
    49
    52
        Right Otoscopy Visit 4- Abnormal (n=62, n=60)
    13
    8
        Left Otoscopy: Visit 2- Normal (n=66, n=66)
    49
    52
        Left Otoscopy: Visit 2- Abnormal (n=66, n=66)
    17
    14
        Left Otoscopy Visit 3- Normal (n=65, n=65)
    51
    55
        Left Otoscopy Visit 3- Abnormal (n=65, n=65)
    14
    10
        Left Otoscopy Visit 4- Normal (n=62, n=60)
    48
    52
        Left Otoscopy Visit 4- Abnormal (n=62, n=60)
    14
    8
    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.
    No statistical analyses for this end point

    Secondary: Number of Participants with Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic

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    End point title
    		 Number of Participants with Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
    End point description
    Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [11]
    66 [12]
    Units: Participants
    number (not applicable)
        Visit 2- Normal Appearance (n=66, n=66)
    50
    46
        Visit 2 Hypertrophic (n=66, n=66)
    16
    20
        Vist 2 Hypotrophic (n=66, n=66)
    0
    0
        Visit 3 Normal Appearance (n=65, n=65)
    46
    48
        Visit 3 Hypertrophic (n=65, n=65)
    19
    17
        Visit 3 Hypotrophic (n=65, n=65)
    0
    0
        Visit 4 Normal Appearance (n=62, n=60)
    45
    42
        Visit 4 Hypertrophic (n=62, n=60)
    17
    18
        Visit 4 Hypotrophic (n=62, n=60)
    0
    0
    Notes
    [11] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [12] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction

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    End point title
    		 Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
    End point description
    Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [13]
    66 [14]
    Units: Participants
    number (not applicable)
        Visit 2- Patent (n=66, n=66)
    62
    60
        Visit 2- Partial Obstruction (n=66, n=66)
    3
    5
        Visit 2- Total Obstruction (n=66, n=66)
    1
    1
        Visit 3- Patent (n=65, n=65)
    61
    61
        Visit 3- Partial Obstruction (n=65, n=65)
    4
    2
        Visit 3- Total Obstruction (n=65, n=65)
    0
    2
        Visit 4- Patent (n=62, n=60)
    56
    53
        Visit 4- Partial Obstruction (n= 62, n=60)
    6
    4
        Visit 4- Total Obstruction (n=62, n=60)
    0
    3
    Notes
    [13] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [14] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance

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    End point title
    		 Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
    End point description
    Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [15]
    20 [16]
    Units: Pa/cm^3/sec
    arithmetic mean (standard deviation)
        Visit 2- Left Nasal Fossa (n=19, n=20)
    2.111 ( 4.372 )
    3.28 ( 7.852 )
        Visit 3- Left Nasal Fossa (n=18, n=18)
    6.341 ( 22.759 )
    1.934 ( 2.234 )
        Visit 4- Left Nasal Fossa (n=19, n=19)
    31.074 ( 131.718 )
    54.724 ( 229.437 )
        Visit 2- Right Nasal Fossa (n=19, n=20)
    2.985 ( 8.527 )
    6.535 ( 24.836 )
        Visit 3- Right Nasal Fossa (n=18, n=18)
    1.823 ( 4.454 )
    3.026 ( 8.258 )
        Visit 4- Right Nasal Fossa (n=19, n=19)
    2.56 ( 6.918 )
    43.621 ( 174.535 )
    Notes
    [15] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [16] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance

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    End point title
    		 Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
    End point description
    Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [17]
    20 [18]
    Units: Pa/cm^3/sec
    arithmetic mean (standard deviation)
        Visit 2- Left Nasal Fossa (n=19, n=20)
    1.771 ( 2.764 )
    3.994 ( 9.416 )
        Visit 3- Left Nasal Fossa (n=18, n=18)
    2.937 ( 8.196 )
    1.478 ( 1.647 )
        Visit 4- Left Nasal Fossa (n=19, n=19)
    13.488 ( 32.344 )
    4.148 ( 13.999 )
        Visit 2- Right Nasal Fossa (n=19, n=20)
    2.625 ( 6.868 )
    1.083 ( 1.109 )
        Visit 3- Right Nasal Fossa (n=18, n=18)
    2.189 ( 4.678 )
    3.646 ( 8.313 )
        Visit 4- Right Nasal Fossa (n=19, n=19)
    0.961 ( 0.758 )
    2.792 ( 6.318 )
    Notes
    [17] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [18] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa

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    End point title
    		 Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
    End point description
    Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [19]
    20 [20]
    Units: cm^3/sec
    arithmetic mean (standard deviation)
        Visit 2- Left Nasal Fossa (n=19, n=20)
    200.53 ( 140.492 )
    178.933 ( 129.272 )
        Visit 3- Left Nasal Fossa (n=18, n=18)
    222.152 ( 141.74 )
    151.268 ( 130.115 )
        Visit 4- Left Nasal Fossa (n=19, n=19)
    194.208 ( 100.746 )
    172.346 ( 102.607 )
        Visit 2- Right Nasal Fossa (n=19, n=20)
    183.562 ( 121.78 )
    161.958 ( 138.673 )
        Visit 3- Right Nasal Fossa (n=18, n=18)
    228.661 ( 149.318 )
    197.266 ( 123.763 )
        Visit 4- Right Nasal Fossa (n=19, n=19)
    215.4 ( 157.794 )
    183.368 ( 117.677 )
    Notes
    [19] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [20] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa

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    End point title
    		 Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
    End point description
    Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [21]
    20 [22]
    Units: cm^3/sec
    arithmetic mean (standard deviation)
        Visit 2- Left Nasal Fossa (n=19, n=20)
    190.024 ( 146.067 )
    166.93 ( 116.802 )
        Visit 3- Left Nasal Fossa (n=18, n=18)
    225.911 ( 154.83 )
    173.139 ( 151.783 )
        Visit 4- Left Nasal Fossa (n=19, n=19)
    181.026 ( 119.728 )
    192.374 ( 134.337 )
        Visit 2- Right Nasal Fossa (n=19, n=20)
    160.531 ( 117.988 )
    166.302 ( 132.754 )
        Visit 3- Right Nasal Fossa (n=18, n=18)
    209.676 ( 157.215 )
    209.787 ( 151.298 )
        Visit 4- Right Nasal Fossa (n=19, n=19)
    195.108 ( 163.411 )
    176.587 ( 111.421 )
    Notes
    [21] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [22] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants with Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done

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    End point title
    		 Number of Participants with Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
    End point description
    Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [23]
    21 [24]
    Units: Participants
    number (not applicable)
        Visit 2- Normal (n=19 MFNS, n=21 Placebo)
    13
    18
        Visit 2- Abnormal (n=19 MFNS, n=21 Placebo)
    5
    2
        Visit 2- Not Done (n=19 MFNS, n= 21 Placebo)
    1
    1
        Visit 3- Normal (n=20 MFNS, n=21 Placebo)
    15
    20
        Visit 3- Abnormal (n=20 MFNS, n=21 Placebo)
    4
    1
        Visit 3- Not Done (n=20 MFNS, n=21 Placebo)
    1
    0
        Visit 4- Normal (n=19 MFNS, n=20 Placebo)
    15
    18
        Visit 4- Abnormal (n=19 MFNS, n=20 Placebo)
    2
    2
        Visit 4- Not Done (n=19 MFNS, n=20 Placebo)
    2
    0
    Notes
    [23] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [24] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa

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    End point title
    		 Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
    End point description
    Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities. Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) & were reported in cm^3.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [25]
    20 [26]
    Units: cm^3
    arithmetic mean (standard deviation)
        Visit 2- Left Nasal Fossa (n=19, n=20)
    0.599 ( 0.567 )
    0.491 ( 0.265 )
        Visit 3- Left Nasal Fossa (n=18, n=18)
    0.608 ( 0.485 )
    0.594 ( 0.403 )
        Visit 4- Left Nasal Fossa (n=19, n=19)
    0.662 ( 0.444 )
    0.661 ( 0.444 )
        Visit 2- Right Nasal Fossa (n=19, n=20)
    0.532 ( 0.467 )
    0.577 ( 0.381 )
        Visit 3- Right Nasal Fossa (n=18, n=18)
    0.581 ( 0.405 )
    0.596 ( 0.383 )
        Visit 4- Right Nasal Fossa (n=19, n=19)
    0.734 ( 0.599 )
    0.814 ( 0.675 )
    Notes
    [25] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [26] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa

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    End point title
    		 Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
    End point description
    Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    19 [27]
    20 [28]
    Units: cm^3
    arithmetic mean (standard deviation)
        Visit 2- Left Nasal Fossa (n=19, n=20)
    4.245 ( 1.954 )
    4.117 ( 3.554 )
        Visit 3- Left Nasal Fossa (n=18, n=18)
    3.725 ( 1.944 )
    3.489 ( 1.589 )
        Visit 4- Left Nasal Fossa (n=19, n=19)
    3.631 ( 0.905 )
    3.084 ( 1.724 )
        Visit 2- Right Nasal Fossa (n=19, n=20)
    3.566 ( 1.629 )
    4.489 ( 2.941 )
        Visit 3- Right Nasal Fossa (n=18, n=18)
    4.183 ( 1.341 )
    4.884 ( 3.591 )
        Visit 4- Right Nasal Fossa (n=19, n=19)
    3.774 ( 1.24 )
    3.275 ( 1.083 )
    Notes
    [27] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [28] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants with Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe

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    End point title
    		 Number of Participants with Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
    End point description
    PSQ consists of 90 variables divided into 3 different factors: snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1 (never)-3 (always), and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [29]
    65 [30]
    Units: Participants
    number (not applicable)
        Visit 2- Mild (n=66 MFNS, n=65 Placebo)
    33
    30
        Visit 2- Moderate (n=66 MFNS, n=65 Placebo)
    17
    26
        Visit 2- Severe (n=66 MFNS, n=65 Placebo)
    16
    9
        Visit 3- Mild (n=65 MFNS, n=65 Placebo)
    50
    45
        Visit 3- Moderate (n=65 MFNS, n=Placebo)
    11
    17
        Visit 3- Severe (n=65 MFNS, n=65 Placebo)
    4
    3
        Visit 4- Mild (n=62 MFNS, n=59 Placebo)
    49
    47
        Visit 4- Moderate (n=62 MFNS, n=59 Placebo)
    13
    10
        Visit 4- Severe (n=62 MFNS, n= 59 Placebo)
    0
    2
    Notes
    [29] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [30] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)

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    End point title
    		 Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
    End point description
    The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS & 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    23 [31]
    29 [32]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 2 (n= 23 MFNS, n=29 Placebo)
    78.442 ( 13.114 )
    78.017 ( 14.769 )
        Visit 3 (n=22 MFNS, n= 28 Placebo)
    80.438 ( 15.827 )
    78.486 ( 15.707 )
        Visit 4 (n=18 MFNS, n=25 Placebo)
    80.137 ( 15.161 )
    82.701 ( 11.911 )
    Notes
    [31] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [32] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)

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    End point title
    		 Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
    End point description
    The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS & 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    28 [33]
    24 [34]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 2 (n= 28 MFNS, n=24 Placebo)
    78.14 ( 15.74 )
    79.03 ( 11.35 )
        Visit 3 (n=28 MFNS, n= 23 Placebo)
    81.56 ( 13.64 )
    84.07 ( 12.26 )
        Visit 4 (n=28 MFNS, n=22 Placebo)
    83.54 ( 13.63 )
    82.71 ( 13.52 )
    Notes
    [33] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [34] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)

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    End point title
    		 Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
    End point description
    The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS & 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    15 [35]
    14 [36]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 2 (n= 15 MFNS, n=13 Placebo)
    76.014 ( 10.266 )
    76.839 ( 10.828 )
        Visit 3 (n=15 MFNS, n= 14 Placebo)
    82.971 ( 15.054 )
    84.006 ( 14.033 )
        Visit 4 (n=15 MFNS, n=13 Placebo)
    85.725 ( 12.033 )
    83.946 ( 10.023 )
    Notes
    [35] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [36] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score

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    End point title
    		 Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
    End point description
    18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126). Grading was as follows: -Scores < 60 suggest a slight impact on health related quality of life (HRQL) -Scores 60-80 suggest a moderate impact -Scores over 80 suggest a great impact 1 participant in Placebo group did not answer this questionnaire at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [37]
    65 [38]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 2 (n=66 MFNS, n=65 Placebo)
    62.742 ( 19.951 )
    60.169 ( 19.123 )
        Visit 3 (n=65 MFNS, n= 65 Placebo)
    47.138 ( 18.806 )
    48.769 ( 18.748 )
        Visit 4 (n=62 MFNS, n= 59 Placebo)
    42.742 ( 17.88 )
    43.068 ( 18.87 )
    Notes
    [37] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [38] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation

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    End point title
    		 Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
    End point description
    Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    End point values
    		 Mometasone Furoate nasal spray Placebo nasal spray
    Number of subjects analysed
    66 [39]
    66 [40]
    Units: Participants
    number (not applicable)
        Visit 2 Aligned (n= 66, n=66)
    65
    63
        Visit 2 Non-obstructive Deviation (n= 66, n=66)
    1
    3
        Vist 2 Obstructive Deviation (n=66, n=66)
    0
    0
        Visit 3 Aligned (n=65, n=65)
    64
    62
        Visit 3 Non-obstructive Deviation (n=65, n=65)
    1
    3
        Visit 3 Obstructive Deviation (n=65, n=65)
    0
    0
        Visit 4 Aligned (n=62, n=60)
    61
    57
        Visit 4 Non-obstructive Deviation (n=62, n=60)
    1
    3
        Visit 4 -Obstructive Deviation (n=62, n=60)
    0
    0
    Notes
    [39] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    [40] - All randomized participants who took ≥1 study drug dose and were evaluable for this end point.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Reporting group title
    Mometasone Furoate nasal spray
    Reporting group description
    		 1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

    Serious adverse events
    		 Placebo nasal spray Mometasone Furoate nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 66 (3.03%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Orchitis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
         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
    		 Placebo nasal spray Mometasone Furoate nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 66 (25.76%)
    18 / 66 (27.27%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 66 (6.06%)
    5 / 66 (7.58%)
         occurrences all number
    5
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 66 (6.06%)
    1 / 66 (1.52%)
         occurrences all number
    4
    1
    Epistaxis
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 66 (4.55%)
         occurrences all number
    14
    4
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    3 / 66 (4.55%)
    4 / 66 (6.06%)
         occurrences all number
    4
    7
    Nasopharyngitis
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 66 (4.55%)
         occurrences all number
    4
    3
    Pharyngotonsillitis
         subjects affected / exposed
    4 / 66 (6.06%)
    2 / 66 (3.03%)
         occurrences all number
    6
    2
    Sinusitis
         subjects affected / exposed
    2 / 66 (3.03%)
    4 / 66 (6.06%)
         occurrences all number
    2
    5

    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.
    The results of this study as presented are drawn from the clinical study report and should be reviewed with caution as there were inaccuracies in the database resulting from medication errors in some participants.
    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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