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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent subjects with Allergic Rhinitis

    Summary
    EudraCT number
    		 2015-004889-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2017
    First version publication date
    22 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    113342
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    Interim
    Date of interim/final analysis
    31 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Sep 2009
    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
    China: 365
    Worldwide total number of subjects
    365
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    16
    Adults (18-64 years)
    349
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of the 365 randomized patients, two patients did not take any study dose and are not considered for the baseline characteristics.

    Pre-assignment
    Screening details
    		 A total of 365 participants were screened and randomized into the study

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FFNS 110 mcg
    Arm description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Furoate Nasal Spray (FFNS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    FFNS was provided as an aqueous suspension, with each spray delivering approximately 27.5 µg (micrograms) of fluticasone furoate. Four sprays (two in each nostril), equivalent to 110 mcg, were administered in the morning, once daily for 2 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Matching Vehicle Placebo Nasal Spray QD
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Four sprays (two in each nostril), of the FFNS-matching placebo, were administered in the morning, once daily for 2 weeks. The placebo contained only the vehicle used in FFNS.

    Number of subjects in period 1 [1]
    		FFNS 110 mcg Placebo
    Started
    181
    182
    Completed
    177
    176
    Not completed
    4
    6
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    2
         Protocol deviation
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 365 worldwide randomized participants, two participants did not take any study dose and are not considered in the baseline characteristics.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FFNS 110 mcg
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Vehicle Placebo Nasal Spray QD

    Reporting group values
    		 FFNS 110 mcg Placebo Total
    Number of subjects
    		 181 182
    Age categorical
    Units: Subjects
    Age continuous
    Baseline characteristics are summarized for the Full Analysis Set (FAS), comprised of all participants who were randomized and received at least one dose of study medication.
    Units: years
        arithmetic mean (standard deviation)
    		 31.8 ± 10.72 33 ± 10.95 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 97 99 196
        Male
    		 84 83 167
    Race/Ethnicity, Customized
    Units: Subjects
        Chinese
    		 181 182 363
        Not Chinese
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    FFNS 110 mcg
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Vehicle Placebo Nasal Spray QD

    Primary: Mean change from baseline over the entire treatment period in the daily reflective total nasal symptom score (rTNSS)

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    End point title
    		 Mean change from baseline over the entire treatment period in the daily reflective total nasal symptom score (rTNSS)
    End point description
    The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.
    End point type
    Primary
    End point timeframe
    Baseline through entire treatment period (Day 1 through Day 14)
    End point values
    		 FFNS 110 mcg Placebo
    Number of subjects analysed
    179 [1]
    178 [2]
    Units: Points on a scale
        least squares mean (standard error)
    -4.226 ± 0.1646
    -2.728 ± 0.1656
    Notes
    [1] - Full Analysis Set (FAS):All participants who were randomized and received 1 dose of study medication
    [2] - Full Analysis Set (FAS):All participants who were randomized and received 1 dose of study medication
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FFNS 110 mcg v Placebo
    Number of subjects included in analysis
    357
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -1.498
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.897
         upper limit
    		 -1.009

    Secondary: Mean change from baseline (Visit 2) to the end of study (Visit 4/Early Withdrawal) in nasal finding score by rhinoscopy

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    End point title
    		 Mean change from baseline (Visit 2) to the end of study (Visit 4/Early Withdrawal) in nasal finding score by rhinoscopy
    End point description
    The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
    End point values
    		 FFNS 110 mcg Placebo
    Number of subjects analysed
    176 [3]
    177 [4]
    Units: Points on a scale
        least squares mean (standard error)
    -4.2 ± 0.22
    -2.9 ± 0.22
    Notes
    [3] - FAS Population. Only participants for whom both baseline and post-baseline data were available.
    [4] - FAS Population. Only participants for whom both baseline and post-baseline data were available.
    No statistical analyses for this end point

    Secondary: Mean change from baseline (Visit 2) to the end of study (Visit 4/Early Withdrawal) in severity of overall interference in activities of daily living

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    End point title
    		 Mean change from baseline (Visit 2) to the end of study (Visit 4/Early Withdrawal) in severity of overall interference in activities of daily living
    End point description
    The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
    End point values
    		 FFNS 110 mcg Placebo
    Number of subjects analysed
    160 [5]
    165 [6]
    Units: Points on a scale
        least squares mean (standard error)
    -1.2 ± 0.07
    -0.8 ± 0.07
    Notes
    [5] - FAS Population. Only participants for whom both baseline and post-baseline data were available.
    [6] - FAS Population. Only participants for whom both baseline and post-baseline data were available.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AE data from the time of participants randomization until the follow-up period (approximately 20 days) were collected.
    Adverse event reporting additional description
    Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    FFNS 110 mcg
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Vehicle Placebo Nasal Spray QD

    Serious adverse events
    		 FFNS 110 mcg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 182 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FFNS 110 mcg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 182 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: None of the participants had any non-serious AE at or above 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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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