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    Clinical Trial Results:
    A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects with House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis

    Summary
    EudraCT number
    		 2012-001855-38
    Trial protocol
    		 AT  
    Global end of trial date
    27 Aug 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Jan 2017
    First version publication date
    28 Jan 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    P07627
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01644617
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 P07627: SCH 900237, MK-8237-003: Merck Registration
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose-related efficacy of MK-8237 sublingual house dust mite (HDM) tablet versus placebo in the treatment of HDM-induced rhinitis based on the average total nasal symptom score (TNSS) determined during the chamber challenge session at Week 24.
    Protection of trial subjects
    The 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
    01 Oct 2012
    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
    Austria: 124
    Worldwide total number of subjects
    124
    EEA total number of subjects
    124
    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)
    0
    Adults (18-64 years)
    124
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from one study site in Austria.

    Pre-assignment
    Screening details
    		 This study enrolled male and female participants, 18 years of age and older, with a history of allergic rhinitis/rhinoconjunctivitis to house dust of 1-year duration or more (with or without asthma).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MK-8237 6 DU
    Arm description
    		 Participants receive MK-8237 6 Development Units (DU) sublingual tablets once daily (QD), preferably at the same time each day, for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-8237 6 DU sublingual tablets
    Investigational medicinal product code
    Other name
    SCH 900237
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    One MK-8237 6 DU sublingual tablet once daily for 24 weeks

    Arm title
    		 MK-8237 12 DU
    Arm description
    		 Participants receive MK-8237 12 DU sublingual tablets, QD, preferably at the same time each day, for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-8237 12 DU sublingual tablets
    Investigational medicinal product code
    Other name
    SCH 900237
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    One MK-8237 12 DU sublingual tablet once daily for 24 weeks

    Arm title
    		 Placebo
    Arm description
    		 Participants receive Placebo sublingual tablets, QD, preferably at the same time each day, for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo sublingual tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Placebo sublingual tablets once daily for 24 weeks

    Number of subjects in period 1
    		MK-8237 6 DU MK-8237 12 DU Placebo
    Started
    41
    42
    41
    Completed
    36
    36
    34
    Not completed
    5
    6
    7
         Consent withdrawn by subject
    4
    3
    1
         Adverse event, non-fatal
    -
    3
    6
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MK-8237 6 DU
    Reporting group description
    		 Participants receive MK-8237 6 Development Units (DU) sublingual tablets once daily (QD), preferably at the same time each day, for 24 weeks.

    Reporting group title
    MK-8237 12 DU
    Reporting group description
    		 Participants receive MK-8237 12 DU sublingual tablets, QD, preferably at the same time each day, for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo sublingual tablets, QD, preferably at the same time each day, for 24 weeks.

    Reporting group values
    		 MK-8237 6 DU MK-8237 12 DU Placebo Total
    Number of subjects
    		 41 42 41 124
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 41 42 41 124
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 30 19 17 66
        Male
    		 11 23 24 58

    End points

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    End points reporting groups
    Reporting group title
    MK-8237 6 DU
    Reporting group description
    		 Participants receive MK-8237 6 Development Units (DU) sublingual tablets once daily (QD), preferably at the same time each day, for 24 weeks.

    Reporting group title
    MK-8237 12 DU
    Reporting group description
    		 Participants receive MK-8237 12 DU sublingual tablets, QD, preferably at the same time each day, for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo sublingual tablets, QD, preferably at the same time each day, for 24 weeks.

    Primary: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24

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    End point title
    		 Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
    End point description
    TNSS was the total score for 4 nasal symptoms (itchy nose, blocked nose, runny nose and sneezing), each scored on a 4-point scale (0=No symptoms to 3=Severe symptoms). Total TNSS ranged from 0 to 12 points, with a higher score indicating more severe nasal symptoms. The end point was calculated based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    36 [1]
    36 [2]
    34 [3]
    Units: Score on a Scale
        least squares mean (confidence interval 95%)
    5.47 (4.55 to 6.39)
    3.83 (2.94 to 4.72)
    7.45 (6.57 to 8.33)
    Notes
    [1] - Full Analysis Set (FAS): Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [2] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [3] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    Statistical analysis title
    		 Difference in Least Squares (LS) Means at Week 24
    Statistical analysis description
    Difference in TNSS LS means at Week 24: MK-8237 6 DU vs. Placebo - Analysis via analysis of covariance (ANCOVA) with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.24
         upper limit
    		 -0.72
    Statistical analysis title
    		 Difference in LS Means at Week 24
    Statistical analysis description
    Difference in TNSS LS means at Week 24: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline endpoint score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -3.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.85
         upper limit
    		 -2.39

    Secondary: Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Sessions at Weeks 8, 16 and 24

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    End point title
    		 Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Sessions at Weeks 8, 16 and 24
    End point description
    TSS was the sum of the TNSS and Total Ocular Symptom Score (TOSS). TOSS was the total of scores for 2 ocular symptom scores (gritty feeling/red/itchy eyes and watery eyes), each scored on a 4-point scale (0=No symptoms to 3=Severe symptoms; TOSS range: 0 to 6 points). Total TSS ranged from 0 to 18 points, with a higher score indicating more severe nasal and ocular symptoms. The end point was calculated based on participant diary entries over the last 4 hours of the EEC challenge sessions at Weeks 8, 16 and 24.
    End point type
    Secondary
    End point timeframe
    Week 8, Week 16, Week 24
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39 [4]
    40 [5]
    40 [6]
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Week 8 (n=39, 40, 39)
    7.65 (6.81 to 8.48)
    6.51 (5.52 to 7.51)
    8.48 (7.56 to 9.39)
        Week 16 (n=36, 39, 38)
    7.21 (6.05 to 8.37)
    5.95 (4.92 to 6.99)
    8.58 (7.46 to 9.69)
        Week 24 (n=36, 36, 34)
    6.62 (5.48 to 7.77)
    4.43 (3.2 to 5.66)
    9.27 (7.98 to 10.57)
    Notes
    [4] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [5] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [6] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    Statistical analysis title
    		 Difference in LS Means at Week 24
    Statistical analysis description
    Difference in TSS LS means at Week 24: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=70.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -2.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.35
         upper limit
    		 -0.95
    Statistical analysis title
    		 Difference in LS Means at Week 24
    Statistical analysis description
    Difference in TSS LS means at Week 24: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=70.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -4.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.59
         upper limit
    		 -3.09
    Statistical analysis title
    		 Difference in LS Means at Week 8
    Statistical analysis description
    Difference in TSS LS means at Week 8: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=78.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.181
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.06
         upper limit
    		 0.4
    Statistical analysis title
    		 Difference in LS Means at Week 8
    Statistical analysis description
    Difference in TSS LS means at Week 8: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=79.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -0.64
    Statistical analysis title
    		 Difference in LS Means at Week 16
    Statistical analysis description
    Difference in TSS LS means at Week 16: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=74.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.091
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.96
         upper limit
    		 0.22
    Statistical analysis title
    		 Difference in LS Means at Week 16
    Statistical analysis description
    Difference in TSS LS means at Week 16: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=77.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.12
         upper limit
    		 -1.13

    Secondary: Average Total Ocular Symptom Score (TOSS) During EEC Challenge Sessions at Weeks 8, 16 and 24

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    End point title
    		 Average Total Ocular Symptom Score (TOSS) During EEC Challenge Sessions at Weeks 8, 16 and 24
    End point description
    TOSS was the total of scores for 2 ocular symptom scores (gritty feeling/red/itchy eyes and watery eyes), each scored on a 4-point scale (0=No symptoms to 3=Severe symptoms). Total TOSS ranged from 0 to 6 points, with a higher score indicating more severe ocular symptoms. The end point was calculated based on participant diary entries over the last 4 hours of the EEC challenge sessions at Weeks 8, 16 and 24.
    End point type
    Secondary
    End point timeframe
    Week 8, Week 16, Week 24
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39 [7]
    40 [8]
    40 [9]
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Week 8 (n=39, 40, 39)
    1.45 (0.68 to 1.53)
    1.18 (0.86 to 1.5)
    1.79 (1.36 to 2.22)
        Week 16 (n=36, 39, 38)
    1.54 (1.08 to 1.83)
    1.14 (0.72 to 1.55)
    1.67 (1.22 to 2.12)
        Week 24 (n=36, 36, 34)
    1.1 (1.05 to 2.03)
    0.61 (0.21 to 1)
    1.87 (1.35 to 2.4)
    Notes
    [7] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [8] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [9] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    Statistical analysis title
    		 Difference in LS Means at Week 24
    Statistical analysis description
    Difference in TOSS LS means at Week 24: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=70.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.43
         upper limit
    		 -0.11
    Statistical analysis title
    		 Difference in LS Means at Week 24
    Statistical analysis description
    Difference in TOSS LS means at Week 24: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=70.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 -0.62
    Statistical analysis title
    		 Difference in LS Means at Week 8
    Statistical analysis description
    Difference in TOSS LS means at Week 8: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=78.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.235
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.22
    Statistical analysis title
    		 Difference in LS Means at Week 8
    Statistical analysis description
    Difference in TOSS LS means at Week 8: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=79.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.14
         upper limit
    		 -0.09
    Statistical analysis title
    		 Difference in LS Means at Week 16
    Statistical analysis description
    Difference in TOSS LS means at Week 16: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=74.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.691
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 0.52
    Statistical analysis title
    		 Difference in LS Means at Week 16
    Statistical analysis description
    Difference in TOSS LS means at Week 16: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=77.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.082
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.13
         upper limit
    		 0.07

    Secondary: Change From Baseline in House Dust Mite (HDM)-specific Immunoglobulin E (IgE) Levels at Week 8

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    End point title
    		 Change From Baseline in House Dust Mite (HDM)-specific Immunoglobulin E (IgE) Levels at Week 8
    End point description
    Participant IgE levels against Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) were measured using the Immunocap® assay at baseline and Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Mean Week 8 IgE levels were compared to the mean IgE levels at baseline. Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39 [10]
    40 [11]
    40 [12]
    Units: Log 10 kU/L
    least squares mean (confidence interval 95%)
        D. pteronyssinus
    0.5 (0.41 to 0.59)
    0.63 (0.51 to 0.75)
    0.08 (0.03 to 0.12)
        D. farinae
    0.46 (0.38 to 0.55)
    0.59 (0.48 to 0.7)
    0.07 (0.03 to 0.11)
    Notes
    [10] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [11] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [12] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    Statistical analysis title
    		 Difference in LS Means - D. farinae
    Statistical analysis description
    Difference in LS means for D. farinae IgE levels: MK-8237 6 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.48
    Statistical analysis title
    		 Difference in LS Means - D. farinae
    Statistical analysis description
    Difference in LS means for D. farinae IgE levels: MK-8237 12 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.64
    Statistical analysis title
    		 Difference in LS Means - D. pteronyssinus
    Statistical analysis description
    Difference in LS means for D. pteronyssinus IgE levels: MK-8237 6 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 0.52
    Statistical analysis title
    		 Difference in LS Means - D. pteronyssinus
    Statistical analysis description
    Difference in LS means for D. pteronyssinus IgE levels: MK-8237 12 DU vs Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 0.68

    Secondary: Change From Baseline in HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8

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    End point title
    		 Change From Baseline in HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8
    End point description
    D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at baseline and Week 8. IgG4 levels were expressed in Log 10 scale miligrams/Liter (mg/L). Mean Week 8 IgG4 levels were compared to the mean IgG4 levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39 [13]
    40 [14]
    40 [15]
    Units: Log 10 mg/L
    least squares mean (confidence interval 95%)
        D. pteronyssinus
    0.19 (0.12 to 0.25)
    0.23 (0.13 to 0.33)
    0 (-0.01 to 0.01)
        D. farinae
    0.24 (0.16 to 0.32)
    0.32 (0.22 to 0.41)
    -0.01 (-0.03 to 0.01)
    Notes
    [13] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [14] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [15] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    Statistical analysis title
    		 Difference in LS Means - D. pteronyssinus
    Statistical analysis description
    Difference in LS means in D. pteronyssinus IgG4 levels: MK-8237 6 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 0.25
    Statistical analysis title
    		 Difference in LS Means - D. pteronyssinus
    Statistical analysis description
    Difference in LS means in D. pteronyssinus IgG4 levels: MK-8237 12 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.33
    Statistical analysis title
    		 Difference in LS Means - D. farinae
    Statistical analysis description
    Difference in LS means in D. farinae IgG4 levels: MK-8237 6 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.33
    Statistical analysis title
    		 Difference in LS Means - D. farinae
    Statistical analysis description
    Difference in LS means in D. farinae IgG4 levels: MK-8237 12 DU vs. Placebo - Analysis via ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 0.42

    Secondary: Average TNSS During EEC Challenge Sessions at Weeks 8 and 16

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    End point title
    		 Average TNSS During EEC Challenge Sessions at Weeks 8 and 16
    End point description
    TNSS was the total score for 4 nasal symptoms (itchy nose, blocked nose, runny nose and sneezing), each scored on a 4-point scale (0=No symptoms to 3=Severe symptoms). Total TNSS ranged from 0 to 12 points, with a higher score indicating more severe nasal symptoms. The end point was calculated based on participant diary entries over the last 4 hours of the EEC challenge sessions at Weeks 8 and 16.
    End point type
    Secondary
    End point timeframe
    Week 8, Week 16
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39 [16]
    40 [17]
    40 [18]
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Week 8 (n=39, 40, 39)
    6.16 (5.55 to 6.78)
    5.34 (4.53 to 6.15)
    6.71 (6.13 to 7.28)
        Week 16 (n=36, 39, 38)
    5.67 (4.83 to 6.5)
    4.82 (4.07 to 5.56)
    6.9 (6.13 to 7.67)
    Notes
    [16] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [17] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    [18] - FAS: Took ≥1 study drug dose and had ≥1 post-randomization efficacy measurement.
    Statistical analysis title
    		 Difference in LS Means at Week 8
    Statistical analysis description
    Difference in TNSS LS means at Week 8: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=78.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.198
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.38
         upper limit
    		 0.29
    Statistical analysis title
    		 Difference in LS Means at Week 16
    Statistical analysis description
    Difference in TNSS LS means at Week 16: MK-8237 6 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=74.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.36
         upper limit
    		 -0.11
    Statistical analysis title
    		 Difference in LS Means at Week 8
    Statistical analysis description
    Difference in TNSS LS means at Week 8: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=79.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 -0.39
    Statistical analysis title
    		 Difference in LS Means at Week 16
    Statistical analysis description
    Difference in TNSS LS means at Week 16: MK-8237 12 DU vs. Placebo - Analysis via ANCOVA with treatment and Baseline end point score as fixed effects, and adjusted for different error variation for each treatment group. Treatment difference relative to Placebo was calculated by (MK-8237-Placebo)/Placebo * 100%. Confidence intervals were calculated by the bootstrap method. Number of participants included in analysis=77.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -2.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.14
         upper limit
    		 -1.03

    Secondary: Number of Participants Who Experienced At Least One Adverse Event (AE)

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    End point title
    		 Number of Participants Who Experienced At Least One Adverse Event (AE)
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug.
    End point type
    Secondary
    End point timeframe
    Up to 26 weeks (Up to 2 weeks after last dose of study drug)
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    41 [19]
    42 [20]
    41 [21]
    Units: Participants
    36
    38
    32
    Notes
    [19] - All Participants as Treated (APaT): All randomized participants who took ≥1 study drug dose.
    [20] - APaT: All randomized participants who took ≥1 study drug dose.
    [21] - APaT: All randomized participants who took ≥1 study drug dose.
    Statistical analysis title
    		 Difference in Percentage vs. Placebo
    Statistical analysis description
    Difference in percentage of participants who experienced at least one AE vs. Placebo: MK-8237 12 DU vs. Placebo - Analysis based on Miettinen & Nurminen method.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    12.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 28.9
    Statistical analysis title
    		 Difference in Percentage vs. Placebo
    Statistical analysis description
    Difference in percentage of participants who experienced at least one AE vs. Placebo: MK-8237 6 DU vs. Placebo - Analysis based on Miettinen & Nurminen method.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 26.6

    Secondary: Number of Participants Who Discontinued Study Drug Due to an AE

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    End point title
    		 Number of Participants Who Discontinued Study Drug Due to an AE
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    41 [22]
    42 [23]
    41 [24]
    Units: Participants
    0
    3
    6
    Notes
    [22] - APaT: All randomized participants who took ≥1 study drug dose.
    [23] - APaT: All randomized participants who took ≥1 study drug dose.
    [24] - APaT: All randomized participants who took ≥1 study drug dose.
    Statistical analysis title
    		 Difference in Percentage vs. Placebo
    Statistical analysis description
    Difference in percentage of participants who discontinued study drug due to an AE vs. Placebo: MK-8237 6 DU vs. Placebo - Analysis based on Miettinen & Nurminen method.
    Comparison groups
    MK-8237 6 DU v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -14.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.5
         upper limit
    		 -5.4
    Statistical analysis title
    		 Difference in Percentage vs. Placebo
    Statistical analysis description
    Difference in percentage of participants who discontinued study drug due to an AE vs. Placebo: MK-8237 12 DU vs. Placebo - Analysis based on Miettinen & Nurminen method.
    Comparison groups
    MK-8237 12 DU v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.6
         upper limit
    		 6.7

    Secondary: HDM-specific IgE Levels at Week 8

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    End point title
    		 HDM-specific IgE Levels at Week 8
    End point description
    D. pteronyssinus and D. farinae serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kU/L. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgE with a standard deviation.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39
    40
    39
    Units: Log 10 kU/L
    arithmetic mean (standard deviation)
        D. pteronyssinus
    1.64 ( 0.53 )
    1.77 ( 0.67 )
    1.25 ( 0.54 )
        D. farinae
    1.69 ( 0.53 )
    1.8 ( 0.67 )
    1.31 ( 0.55 )
    No statistical analyses for this end point

    Secondary: HDM-specific IgG4 Levels at Week 8

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    End point title
    		 HDM-specific IgG4 Levels at Week 8
    End point description
    D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at Week 8. IgG4 levels were expressed in Log 10 scale mg/L. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgG4 with a standard deviation.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Number of subjects analysed
    39
    40
    39
    Units: Log 10 mg/L
    arithmetic mean (standard deviation)
        D. pteronyssinus
    -0.33 ( 0.31 )
    -0.31 ( 0.4 )
    -0.57 ( 0.11 )
        D. farinae
    -0.31 ( 0.41 )
    -0.32 ( 0.47 )
    -0.62 ( 0.22 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 26 weeks (Up to 2 weeks after last dose of study drug)
    Adverse event reporting additional description
    APaT: All randomized participants who took ≥1 study drug dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    MK-8237 6 DU
    Reporting group description
    		 Participants receive MK-8237 6 Development Units (DU) sublingual tablets once daily (QD), preferably at the same time each day, for 24 weeks

    Reporting group title
    MK-8237 12 DU
    Reporting group description
    		 Participants receive MK-8237 12 DU sublingual tablets, QD, preferably at the same time each day, for 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo sublingual tablets, QD, preferably at the same time each day, for 24 weeks

    Serious adverse events
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-8237 6 DU MK-8237 12 DU Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 41 (85.37%)
    36 / 42 (85.71%)
    24 / 41 (58.54%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 41 (14.63%)
    7 / 42 (16.67%)
    8 / 41 (19.51%)
         occurrences all number
    9
    9
    13
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 42 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    1
    3
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 42 (9.52%)
    0 / 41 (0.00%)
         occurrences all number
    2
    6
    0
    Lip swelling
         subjects affected / exposed
    2 / 41 (4.88%)
    8 / 42 (19.05%)
    1 / 41 (2.44%)
         occurrences all number
    2
    9
    2
    Oedema mouth
         subjects affected / exposed
    10 / 41 (24.39%)
    10 / 42 (23.81%)
    0 / 41 (0.00%)
         occurrences all number
    10
    10
    0
    Oral pruritus
         subjects affected / exposed
    6 / 41 (14.63%)
    6 / 42 (14.29%)
    0 / 41 (0.00%)
         occurrences all number
    6
    7
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    2
    3
    1
    Dyspnoea
         subjects affected / exposed
    8 / 41 (19.51%)
    7 / 42 (16.67%)
    13 / 41 (31.71%)
         occurrences all number
    13
    11
    22
    Oropharyngeal pain
         subjects affected / exposed
    4 / 41 (9.76%)
    4 / 42 (9.52%)
    2 / 41 (4.88%)
         occurrences all number
    4
    5
    2
    Rhinitis allergic
         subjects affected / exposed
    7 / 41 (17.07%)
    5 / 42 (11.90%)
    6 / 41 (14.63%)
         occurrences all number
    8
    5
    7
    Rhinitis seasonal
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
         occurrences all number
    3
    1
    2
    Throat irritation
         subjects affected / exposed
    14 / 41 (34.15%)
    22 / 42 (52.38%)
    0 / 41 (0.00%)
         occurrences all number
    15
    26
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 42 (7.14%)
    3 / 41 (7.32%)
         occurrences all number
    5
    3
    3
    Nasopharyngitis
         subjects affected / exposed
    9 / 41 (21.95%)
    12 / 42 (28.57%)
    8 / 41 (19.51%)
         occurrences all number
    11
    16
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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