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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older with Perennial Allergic Rhinitis

    Summary
    EudraCT number
    		 2015-004891-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Feb 2011

    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
    FFR110537
    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
    Final
    Date of interim/final analysis
    29 Mar 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2011
    Was the trial ended prematurely?
    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
    30 Jun 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 548
    Worldwide total number of subjects
    548
    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)
    66
    Adults (18-64 years)
    475
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total 548 participants were 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
    		 Placebo
    Arm description
    		 The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
    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
    Self-administration of Placebo two sprays per nostril each morning once daily

    Arm title
    		 FF 110 mcg QD
    Arm description
    		 FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Furoate (FF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Self-administration of FF nasal spray: two sprays per nostril each morning QD for a total dose of 110 mcg

    Number of subjects in period 1
    		Placebo FF 110 mcg QD
    Started
    181
    367
    Completed
    104
    199
    Not completed
    77
    168
         Physician decision
    2
    6
         Consent withdrawn by subject
    19
    53
         Met Protocol-defined Stopping Criteria
    3
    4
         Adverse event, non-fatal
    12
    23
         Lost to follow-up
    1
    6
         Lack of efficacy
    2
    -
         Protocol deviation
    38
    76

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.

    Reporting group title
    FF 110 mcg QD
    Reporting group description
    		 FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.

    Reporting group values
    		 Placebo FF 110 mcg QD Total
    Number of subjects
    		 181 367
    Age categorical
    Units: Subjects
    Age continuous
    Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who were randomized and received at least one dose of double-blind study drug. One participant in the placebo group and one participant in the FF 110 mcg QD group did not receive any study drug and were thus not included in the ITT Population.
    Units: years
        arithmetic mean (standard deviation)
    		 38 ± 13.34 37 ± 13.48 -
    Gender categorical
    Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who were randomized and received at least one dose of double-blind study drug. One participant in the placebo group and one participant in the FF 110 mcg QD group did not receive any study drug and were thus not included in the ITT Population.
    Units: Subjects
        Female
    		 116 255 371
        Male
    		 65 112 177
    Race/Ethnicity, Customized
    Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who were randomized and received at least one dose of double-blind study drug. One participant in the placebo group and one participant in the FF 110 mcg QD group did not receive any study drug and were thus not included in the ITT Population.
    Units: Subjects
        African American/African Heritage
    		 29 50 79
        American Indian or Alaska Native
    		 1 4 5
        Central/South Asian Heritage
    		 0 1 1
        Japanese/East Asian/South East Asian Heritage
    		 2 6 8
        Mixed Asian Heritage
    		 0 1 1
        Native Hawaiian or other Pacific Islander
    		 2 2 4
        White
    		 146 303 449
        African American/African Heritage & White
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.

    Reporting group title
    FF 110 mcg QD
    Reporting group description
    		 FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.

    Primary: Cumulative proportion (CU) of participants (par.) with an event, as measured as a percentage, for posterior subcapsular opacity (P)

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    End point title
    		 Cumulative proportion (CU) of participants (par.) with an event, as measured as a percentage, for posterior subcapsular opacity (P)
    End point description
    An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table. ITT Population: All participants (par.) with post-base line ophthalmic examination data were included in the analysis for this endpoint. Par. without post-base line ophthalmic exam data were censored at the randomization data . Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.
    End point type
    Primary
    End point timeframe
    Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    168 [1]
    344
    Units: Percentage of participants
    number (not applicable)
        Week 12
    0.6
    0.88
        Week 24
    1.24
    1.84
        Week 36
    1.93
    2.56
        Week 52
    2.68
    3.72
        Week 64
    2.68
    3.72
        Week 76
    2.68
    3.72
        Week 88
    2.68
    4.59
        Week 104
    2.68
    5.09
    Notes
    [1] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FF 110 mcg QD v Placebo
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.395
    Method
    		 Wald Chi-square
    Confidence interval
    Notes
    [2] - Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value

    Primary: Cumulative proportion of participants, as measured as a percentage, with an intraocular pressure (IOP) event

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    End point title
    		 Cumulative proportion of participants, as measured as a percentage, with an intraocular pressure (IOP) event
    End point description
    An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.
    End point type
    Primary
    End point timeframe
    Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    168 [3]
    344
    Units: percentage of participants
    number (not applicable)
        Week 12
    0
    0
        Week 24
    0
    0.32
        Week 36
    0
    0.32
        Week 52
    0
    0.71
        Week 64
    0
    1.12
        Week 76
    0
    1.98
        Week 88
    0.84
    1.98
        Week 104
    0.84
    2.96
    Notes
    [3] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 mcg QD
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.342
    Method
    		 Wald Chi-square
    Confidence interval
    Notes
    [4] - Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value

    Secondary: Change from baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104

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    End point title
    		 Change from baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
    End point description
    An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [5]
    198
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Left eye, Week 52; n=130, 251
    0 ± 0.042
    0 ± 0.063
        Left eye, Week 104; n=104, 198
    0 ± 0.039
    0 ± 0.083
        Right eye, Week 52; n=130, 251
    0 ± 0.057
    0 ± 0.061
        Right eye, Week 104; n=104, 198
    0 ± 0.042
    -0.01 ± 0.068
    Notes
    [5] - ITT population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated change from baseline in LOCS III posterior subcapsular opacity by increments of 0.1 at Weeks 52 and 104

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    End point title
    		 Number of participants with the indicated change from baseline in LOCS III posterior subcapsular opacity by increments of 0.1 at Weeks 52 and 104
    End point description
    An event for P is defined as an increase of >=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [6]
    251
    Units: participants
        Left eye, Week 52, <-0.3; n=130, 251
    0
    0
        Left eye, Week 52, -0.3; n=130, 251
    0
    0
        Left eye, Week 52, -0.2; n=130, 251
    2
    5
        Left eye, Week 52, -0.1; n=130, 251
    3
    13
        Left eye, Week 52, 0; n=130, 251
    121
    218
        Left eye, Week 52, 0.1; n=130, 251
    3
    12
        Left eye, Week 52, 0.2; n=130, 251
    0
    0
        Left eye, Week 52, 0.3; n=130, 251
    1
    2
        Left eye, Week 52, 0.4; n=130, 251
    0
    0
        Left eye, Week 52, 0.5; n=130, 251
    0
    0
        Left eye, Week 52, 0.6; n=130, 251
    0
    1
        Left eye, Week 52, 0.7; n=130, 251
    0
    0
        Left eye, Week 52, 0.8; n=130, 251
    0
    0
        Left eye, Week 52, >=0.9; n=130, 251
    0
    0
        Left eye, Week 52, >=0.3; n=130, 251
    1
    3
        Left eye, Week 52, >=0.5; n=130, 251
    0
    1
        Left eye, Week 52, >=1.0; n=130, 251
    0
    0
        Right eye, Week 52, <-0.3; n=130, 251
    0
    0
        Right eye, Week 52, -0.3; n=130, 251
    1
    0
        Right eye, Week 52, -0.2; n=130, 251
    1
    5
        Right eye, Week 52, -0.1; n=130, 251
    0
    10
        Right eye, Week 52, 0; n=130, 251
    122
    218
        Right eye, Week 52, 0.1; n=130, 251
    4
    13
        Right eye, Week 52, 0.2; n=130, 251
    0
    2
        Right eye, Week 52, 0.3; n=130, 251
    1
    1
        Right eye, Week 52, 0.4; n=130, 251
    1
    2
        Right eye, Week 52, 0.5; n=130, 251
    0
    0
        Right eye, Week 52, 0.6; n=130, 251
    0
    0
        Right eye, Week 52, 0.7; n=130, 251
    0
    0
        Right eye, Week 52, 0.8; n=130, 251
    0
    0
        Right eye, Week 52, >=0.9; n=130, 251
    0
    0
        Right eye, Week 52, >=0.3; n=130, 251
    2
    3
        Right eye, Week 52, >=0.5; n=130, 251
    0
    0
        Right eye, Week 52, >=1.0; n=130, 251
    0
    0
        Left eye, Week 104, <-0.3; n=104, 198
    0
    0
        Left eye, Week 104, -0.3; n=104, 198
    0
    0
        Left eye, Week 104, -0.2; n=104, 198
    2
    5
        Left eye, Week 104, -0.1; n=104, 198
    3
    11
        Left eye, Week 104, 0; n=104, 198
    94
    175
        Left eye, Week 104, 0.1; n=104, 198
    5
    5
        Left eye, Week 104, 0.2; n=104, 198
    0
    0
        Left eye, Week 104, 0.3; n=104, 198
    0
    0
        Left eye, Week 104, 0.4; n=104, 198
    0
    0
        Left eye, Week 104, 0.5; n=104, 198
    0
    0
        Left eye, Week 104, 0.6; n=104, 198
    0
    1
        Left eye, Week 104, 0.7; n=104, 198
    0
    0
        Left eye, Week 104, 0.8; n=104, 198
    0
    1
        Left eye, Week 104, >=0.9; n=104, 198
    0
    0
        Left eye, Week 104, >=0.3; n=104, 198
    0
    2
        Left eye, Week 104, >=0.5; n=104, 198
    0
    2
        Left eye, Week 104, >=1.0; n=104, 198
    0
    0
        Right eye, Week 104, <-0.3; n=104, 198
    0
    0
        Right eye, Week 104, -0.3; n=104, 198
    1
    0
        Right eye, Week 104, -0.2; n=104, 198
    1
    5
        Right eye, Week 104, -0.1; n=104, 198
    2
    14
        Right eye, Week 104, 0; n=104, 198
    97
    174
        Right eye, Week 104, 0.1; n=104, 198
    3
    2
        Right eye, Week 104, 0.2; n=104, 198
    0
    2
        Right eye, Week 104, 0.3; n=104, 198
    0
    0
        Right eye, Week 104, 0.4; n=104, 198
    0
    0
        Right eye, Week 104, 0.5; n=104, 198
    0
    0
        Right eye, Week 104, 0.6; n=104, 198
    0
    0
        Right eye, Week 104, 0.7; n=104, 198
    0
    1
        Right eye, Week 104, 0.8; n=104, 198
    0
    0
        Right eye, Week 104, >=0.9; n=104, 198
    0
    0
        Right eye, Week 104, >=0.3; n=104, 198
    0
    1
        Right eye, Week 104, >=0.5; n=104, 198
    0
    1
        Right eye, Week 104, >=1.0; n=104, 198
    0
    0
    Notes
    [6] - ITT population
    No statistical analyses for this end point

    Secondary: Change from baseline in LOCS III cortical opacity (C) at Week 52 and Week 104

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    End point title
    		 Change from baseline in LOCS III cortical opacity (C) at Week 52 and Week 104
    End point description
    An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [7]
    251
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Left eye, Week 52; n=130, 251
    0.01 ± 0.21
    0 ± 0.113
        Left eye, Week 104; n=104, 198
    0.02 ± 0.21
    0.01 ± 0.186
        Right eye, Week 52; n=130, 251
    -0.01 ± 0.229
    0 ± 0.154
        Right eye, Week 104; n=104, 198
    0.02 ± 0.187
    0.01 ± 0.186
    Notes
    [7] - ITT population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated change from baseline in cortical opacity by increment categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104

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    End point title
    		 Number of participants with the indicated change from baseline in cortical opacity by increment categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
    End point description
    An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [8]
    251
    Units: participants
        Left eye, Week 52, >=0.3; n=130, 251
    4
    4
        Left eye, Week 52, >=0.5; n=130, 251
    1
    0
        Left eye, Week 52, >=1.0; n=130, 251
    1
    0
        Right eye, Week 52, >=0.3; n=130, 251
    3
    8
        Right eye, Week 52, >=0.5; n=130, 251
    1
    2
        Right eye, Week 52, >=1.0; n=130, 251
    1
    0
        Left eye, Week 104, >=0.3; n=104, 198
    6
    10
        Left eye, Week 104, >=0.5; n=104, 198
    3
    4
        Left eye, Week 104, >=1.0; n=104, 198
    1
    1
        Right eye, Week 104, >=0.3; n=104, 198
    3
    10
        Right eye, Week 104, >=0.5; n=104, 198
    2
    4
        Right eye, Week 104, >=1.0; n=104, 198
    1
    2
    Notes
    [8] - ITT population
    No statistical analyses for this end point

    Secondary: Change from baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104

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    End point title
    		 Change from baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
    End point description
    Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [9]
    251
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Left eye, Week 52; n=130, 251
    0.12 ± 0.498
    0.06 ± 0.495
        Left eye, Week 104; n=104, 198
    0.21 ± 0.538
    0.1 ± 0.506
        Right eye, Week 52; n=130, 251
    0.12 ± 0.511
    0.06 ± 0.492
        Right eye, Week 104; n=104, 198
    0.21 ± 0.55
    0.09 ± 0.531
    Notes
    [9] - ITT population
    No statistical analyses for this end point

    Secondary: Change from baseline in Nuclear Color (NC) at Week 52 and Week 104

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    End point title
    		 Change from baseline in Nuclear Color (NC) at Week 52 and Week 104
    End point description
    Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [10]
    251
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Left eye, Week 52; n=130, 251
    0.14 ± 0.432
    0.09 ± 0.402
        Left eye, Week 104; n=104, 198
    0.21 ± 0.454
    0.13 ± 0.465
        Right eye, Week 52; n=130, 251
    0.16 ± 0.422
    0.09 ± 0.41
        Right eye, Week 104; n=104, 198
    0.22 ± 0.452
    0.13 ± 0.469
    Notes
    [10] - ITT population
    No statistical analyses for this end point

    Secondary: Change from baseline in intraocular pressure (IOP) at Weeks 52 and 104

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    End point title
    		 Change from baseline in intraocular pressure (IOP) at Weeks 52 and 104
    End point description
    An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [11]
    251
    Units: mm Hg
    arithmetic mean (standard deviation)
        Left eye, Week 52; n=130, 251
    -0.5 ± 2.04
    -0.3 ± 2.26
        Left eye, Week 104; n=104, 198
    -0.8 ± 1.98
    -0.6 ± 2.41
        Right eye, Week 52; n=130, 251
    -0.7 ± 2.08
    -0.4 ± 2.33
        Right eye, Week 104; n=104, 198
    -1 ± 2.17
    -0.7 ± 2.55
    Notes
    [11] - ITT population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated change from baseline in intraocular pressure (IOP) by increments of 1 mm Hg at Week 52

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    End point title
    		 Number of participants with the indicated change from baseline in intraocular pressure (IOP) by increments of 1 mm Hg at Week 52
    End point description
    An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [12]
    251
    Units: participants
        Left eye, IOP = <-10 to -9
    1
    0
        Left eye, IOP = -8
    0
    0
        Left eye, IOP = -7
    0
    2
        Left eye, IOP = -6
    0
    0
        Left eye, IOP = -5
    3
    3
        Left eye, IOP = -4
    5
    12
        Left eye, IOP = -3
    9
    19
        Left eye, IOP = -2
    18
    40
        Left eye, IOP = -1
    22
    40
        Left eye, IOP = 0
    36
    50
        Left eye, IOP = 1
    20
    30
        Left eye, IOP = 2
    7
    24
        Left eye, IOP = 3
    5
    19
        Left eye, IOP = 4
    4
    7
        Left eye, IOP = 5
    0
    3
        Left eye, IOP = 6
    0
    2
        Left eye, IOP = 7
    0
    0
        Left eye, IOP = 8
    0
    0
        Left eye, IOP = 9
    0
    0
        Left eye, IOP >= 7
    0
    0
        Left eye, IOP >= 10
    0
    0
        Left eye, IOP >= 15
    0
    0
        Right eye, IOP = <-10 to -9
    0
    0
        Right eye, IOP = -8
    0
    1
        Right eye, IOP = -7
    2
    0
        Right eye, IOP = -6
    0
    1
        Right eye, IOP = -5
    2
    4
        Right eye, IOP = -4
    7
    14
        Right eye, IOP = -3
    9
    23
        Right eye, IOP = -2
    25
    43
        Right eye, IOP = -1
    22
    34
        Right eye, IOP = 0
    28
    46
        Right eye, IOP = 1
    16
    31
        Right eye, IOP = 2
    13
    27
        Right eye, IOP = 3
    3
    14
        Right eye, IOP = 4
    2
    8
        Right eye, IOP = 5
    1
    2
        Right eye, IOP = 6
    0
    3
        Right eye, IOP = 7
    0
    0
        Right eye, IOP = 8
    0
    0
        Right eye, IOP = 9
    0
    0
        Right eye, IOP >= 7
    0
    0
        Right eye, IOP >= 10
    0
    0
        Right eye, IOP >= 15
    0
    0
    Notes
    [12] - ITT population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated change from baseline in intraocular pressure (IOP) by increments of 1 mm Hg at Week 104

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    End point title
    		 Number of participants with the indicated change from baseline in intraocular pressure (IOP) by increments of 1 mm Hg at Week 104
    End point description
    An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    104 [13]
    198
    Units: participants
        Left eye, IOP = <-10 to -9
    0
    0
        Left eye, IOP = -8
    0
    1
        Left eye, IOP = -7
    0
    0
        Left eye, IOP = -6
    2
    3
        Left eye, IOP = -5
    0
    7
        Left eye, IOP = -4
    6
    10
        Left eye, IOP = -3
    15
    19
        Left eye, IOP = -2
    17
    31
        Left eye, IOP = -1
    15
    32
        Left eye, IOP = 0
    21
    32
        Left eye, IOP = 1
    19
    30
        Left eye, IOP = 2
    5
    16
        Left eye, IOP = 3
    3
    7
        Left eye, IOP = 4
    0
    6
        Left eye, IOP = 5
    1
    2
        Left eye, IOP = 6
    0
    1
        Left eye, IOP = 7
    0
    1
        Left eye, IOP = 8
    0
    0
        Left eye, IOP = 9
    0
    0
        Left eye, IOP >= 7
    0
    1
        Left eye, IOP >= 10
    0
    0
        Left eye, IOP >= 15
    0
    0
        Right eye, IOP = <-10 to -9
    0
    0
        Right eye, IOP = -8
    0
    1
        Right eye, IOP = -7
    0
    2
        Right eye, IOP = -6
    2
    1
        Right eye, IOP = -5
    5
    7
        Right eye, IOP = -4
    4
    15
        Right eye, IOP = -3
    10
    17
        Right eye, IOP = -2
    24
    32
        Right eye, IOP = -1
    21
    22
        Right eye, IOP = 0
    12
    46
        Right eye, IOP = 1
    16
    23
        Right eye, IOP = 2
    6
    13
        Right eye, IOP = 3
    1
    8
        Right eye, IOP = 4
    1
    5
        Right eye, IOP = 5
    1
    2
        Right eye, IOP = 6
    1
    2
        Right eye, IOP = 7
    0
    2
        Right eye, IOP = 8
    0
    0
        Right eye, IOP = 9
    0
    0
        Right eye, IOP >= 7
    0
    2
        Right eye, IOP >= 10
    0
    0
        Right eye, IOP >= 15
    0
    0
    Notes
    [13] - ITT population
    No statistical analyses for this end point

    Secondary: Change from baseline in logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (VA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at Week 52 and Week 104

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    End point title
    		 Change from baseline in logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (VA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at Week 52 and Week 104
    End point description
    ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the [decadic] logarithm of the minimum angle of resolution [range from +1.00 to -0.30]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52, and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    130 [14]
    251
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Left eye, Week 52; n=130, 251
    -0.027 ± 0.0729
    -0.013 ± 0.0778
        Left eye, Week 104; n=104, 198
    -0.035 ± 0.074
    -0.023 ± 0.0858
        Right eye, Week 52; n=130, 251
    -0.023 ± 0.081
    -0.014 ± 0.0852
        Right eye, Week 104; n=104, 198
    -0.025 ± 0.0992
    -0.024 ± 0.0899
    Notes
    [14] - ITT population
    No statistical analyses for this end point

    Secondary: Percent change from baseline in the funduscopic horizontal cup-to-disc ratio at Week 104

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    End point title
    		 Percent change from baseline in the funduscopic horizontal cup-to-disc ratio at Week 104
    End point description
    The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the "cup" portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    104 [15]
    198
    Units: percent change
    arithmetic mean (standard deviation)
        Left eye
    0 ± 7.23
    0.7 ± 7.58
        Right eye
    0 ± 7.31
    0 ± 7.39
    Notes
    [15] - ITT population
    No statistical analyses for this end point

    Secondary: Change from baseline in the daily reflective total nasal symptom score (rTNSS) for the indicated study periods

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    End point title
    		 Change from baseline in the daily reflective total nasal symptom score (rTNSS) for the indicated study periods
    End point description
    rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104
    End point values
    		 Placebo FF 110 mcg QD
    Number of subjects analysed
    181 [16]
    367
    Units: scores on a scale
    least squares mean (standard error)
        Week 1 to 26
    -2.12 ± 0.17
    -3.19 ± 0.12
        Week 27 to 52
    -2.52 ± 0.21
    -3.86 ± 0.15
        Week 53 to 78
    -2.56 ± 0.23
    -3.89 ± 0.16
        Week 79 to 104
    -2.59 ± 0.25
    -4.1 ± 0.18
        Week 1 to 104
    -2.3 ± 0.18
    -3.45 ± 0.13
    Notes
    [16] - ITT population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug to Visit 29 (7 days following Visit 28 or early withdrawal)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.

    Reporting group title
    FF 110 mcg QD
    Reporting group description
    		 FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.

    Serious adverse events
    		 Placebo FF 110 mcg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 181 (3.87%)
    12 / 367 (3.27%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 367 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-uterine death
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper airway obstruction
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vitreous floaters
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 367 (0.27%)
         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 FF 110 mcg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    97 / 181 (53.59%)
    232 / 367 (63.22%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 181 (7.18%)
    29 / 367 (7.90%)
         occurrences all number
    28
    60
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    34 / 181 (18.78%)
    123 / 367 (33.51%)
         occurrences all number
    58
    254
    Oropharyngeal pain
         subjects affected / exposed
    9 / 181 (4.97%)
    23 / 367 (6.27%)
         occurrences all number
    13
    27
    Nasal ulcer
         subjects affected / exposed
    3 / 181 (1.66%)
    30 / 367 (8.17%)
         occurrences all number
    3
    36
    Nasal septum ulceration
         subjects affected / exposed
    6 / 181 (3.31%)
    24 / 367 (6.54%)
         occurrences all number
    7
    34
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    31 / 181 (17.13%)
    47 / 367 (12.81%)
         occurrences all number
    45
    63
    Upper respiratory tract infection
         subjects affected / exposed
    29 / 181 (16.02%)
    52 / 367 (14.17%)
         occurrences all number
    58
    89
    Nasopharyngitis
         subjects affected / exposed
    17 / 181 (9.39%)
    44 / 367 (11.99%)
         occurrences all number
    28
    64
    Influenza
         subjects affected / exposed
    16 / 181 (8.84%)
    25 / 367 (6.81%)
         occurrences all number
    16
    26
    Viral upper respiratory tract infection
         subjects affected / exposed
    12 / 181 (6.63%)
    27 / 367 (7.36%)
         occurrences all number
    19
    36
    Bronchitis
         subjects affected / exposed
    8 / 181 (4.42%)
    31 / 367 (8.45%)
         occurrences all number
    10
    43
    Acute sinusitis
         subjects affected / exposed
    7 / 181 (3.87%)
    20 / 367 (5.45%)
         occurrences all number
    7
    27

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2008
    This amendment added a medical monitor to contact sponsor information, Included additional Exclusion Criteria, Allowed re-screening of subjects, Clarified all subjects should have a post-treatment follow-up visit, Clarified when follow-up ophthalmic examinations are required for subjects who withdraw from the study early, Defined a completed subject, Corrected mild intermittent asthma to read intermittent asthma, Added and updated prohibited medications, including allowance for limited use of oral decongestants, Added information regarding weighing of nasal spray devices, Clarified the Visit 2 e-diary review required by clinical sites, Added information in Ophthalmic Examination section relating to ophthalmic solutions used by ophthalmologists when dilating subjects’ eyes, Revised time period ophthalmologist has to send clinical investigator results of ophthalmic examinations, Clarified definition of ‘family’ history of cataract or glaucoma, Added a new section (Glucose Tests) to Clinical Laboratory Tests, Added information regarding the determination of subject compliance rate based on observed dosing via videophone, Added a reference, and Other minor administrative corrections.

    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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