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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects with Perennial Allergic Rhinitis

    Summary
    EudraCT number
    		 2007-005148-26
    Trial protocol
    		 FR   IT  
    Global end of trial date
    17 Mar 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    24 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FFR101782
    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
    12 May 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Argentina: 88
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Chile: 154
    Country: Number of subjects enrolled
    Peru: 37
    Country: Number of subjects enrolled
    United States: 165
    Worldwide total number of subjects
    474
    EEA total number of subjects
    18
    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)
    474
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After screening and a 16-week Baseline Period (Pd.), participants (par.) were randomized 1:1 to each treatment arm during the 52-week Treatment Pd. After the Treatment Pd., par. entered an 8-week Follow-up (FU) Pd. during which all par. received placebo nasal spray. Par. completing at least 12 weeks of treatment were to complete the FU Pd.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo: Double-blind Treatment Period
    Arm description
    		 Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Once daily for 52 weeks

    Arm title
    		 FFNS 110 mcg: Double-blind Treatment Period
    Arm description
    		 Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate nasal spray (110 mg QD)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Once daily fluticasone furoate nasal spray (110 mg) once daily for 52 weeks

    Number of subjects in period 1
    		Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Started
    237
    237
    Completed
    187
    186
    Not completed
    50
    51
         Consent withdrawn by subject
    20
    20
         Physician decision
    2
    4
         Adverse event, non-fatal
    5
    5
         Reached Protocol-defined Stop Criteria
    3
    -
         Lost to follow-up
    5
    7
         Lack of efficacy
    3
    -
         Protocol deviation
    12
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo: Double-blind Treatment Period
    Reporting group description
    		 Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

    Reporting group title
    FFNS 110 mcg: Double-blind Treatment Period
    Reporting group description
    		 Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

    Reporting group values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period Total
    Number of subjects
    		 237 237 474
    Age categorical
    Units: Subjects
    Age continuous
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.
    Units: years
        arithmetic mean (standard deviation)
    		 6.61 ± 0.969 6.64 ± 0.933 -
    Gender categorical
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.
    Units: Subjects
        Female
    		 73 75 148
        Male
    		 164 162 326
    Race, Customized
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.
    Units: Subjects
        African American (Amc)/African Heritage
    		 16 12 28
        Amc Indian or Alaska Native (Alk N)
    		 19 18 37
        Asian
    		 7 5 12
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        White
    		 189 199 388
        African Amc/African and Amc Indian or Alk N
    		 1 0 1
        African Amc/African Heritage and White
    		 1 2 3
        Amc Indian or Alk N and White
    		 1 0 1
        Asian and White
    		 1 1 2
        Native Hawaiian/ Other Pacific Islander and White
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo: Double-blind Treatment Period
    Reporting group description
    		 Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

    Reporting group title
    FFNS 110 mcg: Double-blind Treatment Period
    Reporting group description
    		 Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

    Primary: Mean difference in growth velocities between subjects treated with FFNS 110 μg QD and placebo nasal spray as determined by stadiometry

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    End point title
    		 Mean difference in growth velocities between subjects treated with FFNS 110 μg QD and placebo nasal spray as determined by stadiometry
    End point description
    Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). For each study period (Baseline, Treatment, and Follow-up), growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period.
    End point type
    Primary
    End point timeframe
    Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    218 [1]
    217 [2]
    Units: Centimeters per year (cm/year)
        least squares mean (standard error)
    5.46 ± 0.1
    5.19 ± 0.1
    Notes
    [1] - Growth Population
    [2] - Growth Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.
    Comparison groups
    Placebo: Double-blind Treatment Period v FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.06

    Secondary: Mean 24-hour urinary free cortisol excretion

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    End point title
    		 Mean 24-hour urinary free cortisol excretion
    End point description
    Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval. Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value <1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.
    End point type
    Secondary
    End point timeframe
    Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    168 [3]
    172 [4]
    Units: Micrograms per 24 hours (mcg/24 hours)
    arithmetic mean (standard deviation)
        End of 16-week Baseline Period, n=168, 172
    9.771 ± 6.0479
    9.242 ± 5.5821
        End of 52-week DB Treatment Period, n=163, 169
    11.34 ± 9.6775
    11.125 ± 9.2195
        End of 8-week Follow-up Period, n=161, 167
    10.615 ± 6.6903
    10.311 ± 5.9986
    Notes
    [3] - Urine Cortisol Population
    [4] - Urine Cortisol Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated shifts from Baseline in nasal examination (NE) results

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    End point title
    		 Number of participants with the indicated shifts from Baseline in nasal examination (NE) results
    End point description
    NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (>=1 nostril). ITT=Intent to Treat: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    191 [5]
    188 [6]
    Units: Participants
        Mucosal Bleeding, Improved
    1
    0
        Mucosal Bleeding, No Change
    190
    187
        Mucosal Bleeding, Worsened
    0
    1
        Ulcers, Improved
    0
    0
        Ulcers, No Change
    191
    188
        Ulcers, Worsened
    0
    0
        Polyps, Improved
    1
    0
        Polyps, No Change
    190
    188
        Polyps, Worsened
    0
    0
    Notes
    [5] - ITT Population: participants who had been randomized to and received >=1 dose of study medication
    [6] - ITT Population: participants who had been randomized to and received >=1 dose of study medication
    No statistical analyses for this end point

    Secondary: Mean values for the laboratory parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)

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    End point title
    		 Mean values for the laboratory parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
    End point description
    Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [7]
    234 [8]
    Units: International Units per liter (IU/L)
    arithmetic mean (standard deviation)
        Alk P, Baseline Period, n=231, 234
    246.8 ± 57.45
    249.8 ± 67.81
        Alk P, DB Treatment Period, n=184, 182
    261.9 ± 61.96
    262.9 ± 71.22
        Alk P, Follow-up Period, n=175, 174
    264.2 ± 59.67
    264.6 ± 67.44
        ALT, Baseline Period, n=231, 234
    14.8 ± 4.54
    15.1 ± 4.73
        ALT, DB Treatment Period, n=184, 182
    15.9 ± 8.5
    15.8 ± 5.12
        ALT, Follow-up Period, n=175, 174
    16.7 ± 14.41
    17.2 ± 13.15
        AST, Baseline Period, n=229, 232
    27.4 ± 4.89
    28.1 ± 4.89
        AST, DB Treatment Period, n=175, 179
    27 ± 5.49
    27.6 ± 4.87
        AST, Follow-up Period, n=169, 174
    27.7 ± 8.93
    28.3 ± 10.44
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for the laboratory parameters of Albumin and Total Protein

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    End point title
    		 Mean values for the laboratory parameters of Albumin and Total Protein
    End point description
    Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [9]
    234 [10]
    Units: Grams per liter (g/L)
    arithmetic mean (standard deviation)
        Albumin, Baseline Period, n=231, 234
    45.8 ± 2.29
    46 ± 2.33
        Albumin, DB Treatment Period, n=184, 182
    45.7 ± 2.24
    45.9 ± 2.25
        Albumin, Follow-up Period, n=175, 175
    45.8 ± 2.31
    45.6 ± 2.36
        Total Protein, Baseline Period, n=231, 234
    72 ± 3.78
    71.9 ± 4.3
        Total Protein, DB Treatment Period, n=184, 182
    71.7 ± 3.76
    71.7 ± 3.95
        Total Protein, Follow-up Period, n=175, 175
    71.5 ± 3.66
    71.5 ± 3.83
    Notes
    [9] - ITT Population
    [10] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for the laboratory parameters of Total Bilirubin and Creatinine

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    End point title
    		 Mean values for the laboratory parameters of Total Bilirubin and Creatinine
    End point description
    Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [11]
    234 [12]
    Units: Micromoles (µmol)/L
    arithmetic mean (standard deviation)
        Total Bilirubin, Baseline Period, n=231, 234
    6.9 ± 2.43
    7.2 ± 3.4
        Total Bilirubin, DB Treatment Period, n=184, 182
    7.2 ± 2.69
    7.7 ± 3.56
        Total Bilirubin, Follow-up Period, n=175, 175
    7 ± 2.72
    7.1 ± 3.14
        Creatinine, Baseline Period, n=231, 234
    43.3 ± 7.98
    43.6 ± 7.96
        Creatinine, DB Treatment Period, n=184, 182
    45 ± 8.34
    44.6 ± 8.16
        Creatinine, Follow-up Period, n=175, 175
    44.5 ± 7.38
    45 ± 7.72
    Notes
    [11] - ITT Population
    [12] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for the laboratory parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)

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    End point title
    		 Mean values for the laboratory parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
    End point description
    Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [13]
    234 [14]
    Units: Millimoles (mmol)/L
    arithmetic mean (standard deviation)
        Glucose, Baseline Period, n=230, 231
    4.83 ± 0.683
    4.86 ± 0.69
        Glucose, DB Treatment Period, n=184, 182
    4.82 ± 0.782
    4.78 ± 0.72
        Glucose, Follow-up Period, n=175, 175
    4.87 ± 0.84
    4.85 ± 0.7
        Calcium, Baseline Period, n=229, 232
    2.441 ± 0.0786
    2.435 ± 0.0993
        Calcium, DB Treatment Period, n=175, 179
    2.437 ± 0.0776
    2.44 ± 0.0847
        Calcium, Follow-up Period, n=169, 173
    2.438 ± 0.0769
    2.436 ± 0.082
        Potassium, Baseline Period, n=229, 232
    4.3 ± 0.404
    4.31 ± 0.437
        Potassium, DB Treatment Period, n=175, 179
    4.3 ± 0.373
    4.3 ± 0.345
        Potassium, Follow-up Period, n=169, 173
    4.28 ± 0.362
    4.32 ± 0.409
        Sodium, Baseline Period, n=231, 234
    139.4 ± 1.9
    139.3 ± 1.83
        Sodium, DB Treatment Period, n=184, 182
    139.1 ± 1.65
    139.2 ± 1.58
        Sodium, Follow-up Period, n=175, 175
    139.3 ± 1.89
    139.4 ± 2.19
        Urea/BUN, Baseline Period, n=231, 235
    4.99 ± 1.897
    4.77 ± 1.195
        Urea/BUN, DB Treatment Period, n=184, 182
    4.82 ± 1.315
    4.82 ± 1.294
        Urea/BUN, Follow-up Period, n=175, 175
    4.93 ± 1.219
    4.75 ± 1.274
    Notes
    [13] - ITT Population
    [14] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean hematology values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts

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    End point title
    		 Mean hematology values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts
    End point description
    Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    228 [15]
    231 [16]
    Units: Giga (10^9) cells (Gi)/L
    arithmetic mean (standard deviation)
        Basophil, Baseline Period, n=228, 231
    0.026 ± 0.0176
    0.025 ± 0.0151
        Basophil, DB Treatment Period, n=186, 188
    0.026 ± 0.0198
    0.027 ± 0.0184
        Basophil, Follow-up Period, n=177, 179
    0.026 ± 0.0172
    0.025 ± 0.0165
        Eosinophil, Baseline Period, n=228, 231
    0.395 ± 0.3292
    0.455 ± 0.3859
        Eosinophil, DB Treatment Period, n=186, 188
    0.442 ± 0.3505
    0.394 ± 0.3577
        Eosinophil, Follow-up Period, n=177, 179
    0.419 ± 0.3337
    0.409 ± 0.3296
        Lymphocyte, Baseline Period, n=228, 231
    3.046 ± 0.9686
    2.987 ± 0.9158
        Lymphocyte, DB Treatment Period, n=177, 179
    2.779 ± 0.8038
    2.82 ± 0.8424
        Lymphocyte, Follow-up Period, n=169, 173
    2.871 ± 0.8784
    2.841 ± 0.8107
        WBC, Baseline Period, n=228, 231
    7.71 ± 2.077
    7.36 ± 1.818
        WBC, DB Treatment Period, n=186, 188
    7.14 ± 1.899
    6.98 ± 1.896
        WBC, Follow-up Period, n=177, 179
    7.18 ± 1.945
    6.96 ± 1.894
        Monocyte, Baseline Period, n=228, 231
    0.348 ± 0.1655
    0.373 ± 0.187
        Monocyte, DB Treatment Period, n=186, 188
    0.32 ± 0.1393
    0.343 ± 0.1598
        Monocyte, Follow-up Period, n=177, 179
    0.334 ± 0.1471
    0.326 ± 0.1592
        Segmented Neu, Baseline Period, n=228, 231
    3.892 ± 1.6722
    3.517 ± 1.5347
        Segmented Neu, DB Treatment Period, n=186, 188
    3.572 ± 1.5407
    3.391 ± 1.4828
        Segmented Neu, Follow-up Period, n=177, 179
    3.527 ± 1.5623
    3.354 ± 1.4379
        Platelet, Baseline Period, n=230, 230
    313.8 ± 70.19
    314.1 ± 59.46
        Platelet, DB Treatment Period, n=187, 187
    278.6 ± 55.58
    279.5 ± 49.51
        Platelet, Follow-up Period, n=175, 180
    276.4 ± 49.27
    283.6 ± 59.5
    Notes
    [15] - ITT Population
    [16] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for hemoglobin

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    End point title
    		 Mean values for hemoglobin
    End point description
    Hemoglobin was assessed in participants at the indicated time points. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [17]
    231 [18]
    Units: g/L
    arithmetic mean (standard deviation)
        Baseline Period, n=231, 231
    129.5 ± 7.87
    128.4 ± 8
        DB Treatment Period, n=186, 188
    131.8 ± 7.32
    130.8 ± 7.77
        Follow-up Period, n=177, 180
    132.1 ± 7.43
    130 ± 7.9
    Notes
    [17] - ITT Population
    [18] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for hematocrit

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    End point title
    		 Mean values for hematocrit
    End point description
    Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [19]
    231 [20]
    Units: Percentage of BV occupied by RBCs
    arithmetic mean (standard deviation)
        Baseline Period, n=231, 231
    0.3823 ± 0.02296
    0.3783 ± 0.0248
        DB Treatment Period, n=186, 188
    0.3904 ± 0.02291
    0.3873 ± 0.02481
        Follow-up Period, n=177, 180
    0.3906 ± 0.02227
    0.3844 ± 0.02416
    Notes
    [19] - ITT Population
    [20] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean hematology values for red blood cells (RBCs)

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    End point title
    		 Mean hematology values for red blood cells (RBCs)
    End point description
    RBCs was assessed in participants at the indicated time points. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    231 [21]
    231 [22]
    Units: Trillion (10^12) cells (Ti)/L
    arithmetic mean (standard deviation)
        Baseline Period, n=231, 231
    4.59 ± 0.312
    4.54 ± 0.327
        DB Treatment Period, n=186, 188
    4.56 ± 0.303
    4.53 ± 0.319
        Follow-up Period, n=177, 180
    4.57 ± 0.306
    4.5 ± 0.314
    Notes
    [21] - ITT Population
    [22] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for urine pH

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    End point title
    		 Mean values for urine pH
    End point description
    Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    233 [23]
    229 [24]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline Period, n=233, 229
    6.02 ± 0.477
    6 ± 0.536
        DB Treatment Period, n=182, 181
    6.02 ± 0.547
    6.05 ± 0.507
        Follow-up Period, n=180, 186
    6.05 ± 0.538
    6.05 ± 0.524
    Notes
    [23] - ITT Population
    [24] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean values for urine specific gravity

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    End point title
    		 Mean values for urine specific gravity
    End point description
    Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    233 [25]
    229 [26]
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline Period, n=233, 229
    1.024 ± 0.00718
    1.0234 ± 0.00673
        DB Treatment Period, n=182, 181
    1.0244 ± 0.00695
    1.0234 ± 0.00649
        Follow-up Period, n=180, 186
    1.0237 ± 0.00642
    1.0242 ± 0.00672
    Notes
    [25] - ITT Population
    [26] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated urinalysis results for urine bilirubin and urine nitrite

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    End point title
    		 Number of participants with the indicated urinalysis results for urine bilirubin and urine nitrite
    End point description
    Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    233 [27]
    229 [28]
    Units: Participants
        UB-Neg, Baseline Period, n=233, 229
    233
    229
        UB-Pos, Baseline Period, n=233, 229
    0
    0
        UB-Neg, DB Treatment Period, n=182, 181
    182
    181
        UB-Pos, DB Treatment Period, n=182, 181
    0
    0
        UB-Neg, Follow-up Period, n=180, 186
    180
    186
        UB-Pos, Follow-up Period, n=180, 186
    0
    0
        Urine Nitrite-Neg, Baseline Period, n=233, 229
    232
    228
        Urine Nitrite-Pos, Baseline Period, n=233, 229
    1
    1
        Urine Nitrite-Neg, DB Treatment Period, n=182, 181
    178
    176
        Urine Nitrite-Pos, DB Treatment Period, n=182, 181
    4
    5
        Urine Nitrite-Neg, Follow-up Period, n=180, 186
    179
    183
        Urine Nitrite-Pos, Follow-up Period, n=180, 186
    1
    3
    Notes
    [27] - ITT Population
    [28] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated urinalysis results for urine glucose, urine ketones, and urine proteins

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    End point title
    		 Number of participants with the indicated urinalysis results for urine glucose, urine ketones, and urine proteins
    End point description
    Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    233 [29]
    229 [30]
    Units: Participants
        Urine Glucose-Neg, Baseline Period, n=233, 229
    233
    229
        Urine Glucose-Neg, DB Treatment Period, n=182, 181
    181
    181
        Urine Glucose-Tr, DB Treatment Period, n=182, 181
    1
    0
        Urine Glucose-Neg, Follow-up Period, n=180, 186
    179
    186
        Urine Glucose-1+, Follow-up Period, n=180, 186
    1
    0
        Urine Ketones-Neg, Baseline Period, n=233, 229
    231
    227
        Urine Ketones-Tr, Baseline Period, n=233, 229
    0
    1
        Urine Ketones-1+, Baseline Period, n=233, 229
    2
    1
        Urine Ketones-Neg, DB Treatment Period, n=182, 181
    179
    176
        Urine Ketones-Tr, DB Treatment Period, n=182, 181
    3
    5
        Urine Ketones-Neg, Follow-up Period, n=180, 186
    180
    184
        Urine Ketones-Tr, Follow-up Period, n=180, 186
    0
    1
        Urine Ketones-1+, Follow-up Period, n=180, 186
    0
    1
        Urine Protein-Neg, Baseline Period, n=233, 229
    218
    207
        Urine Protein-Tr, Baseline Period, n=233, 229
    11
    18
        Urine Protein-1+, Baseline Period, n=233, 229
    2
    4
        Urine Protein-2+, Baseline Period, n=233, 229
    2
    0
        Urine Protein-Neg, DB Treatment Period, n=182, 181
    145
    152
        Urine Protein-Tr, DB Treatment Period, n=182, 181
    20
    20
        Urine Protein-1+, DB Treatment Period, n=182, 181
    14
    7
        Urine Protein-2+, DB Treatment Period, n=182, 181
    2
    2
        Urine Protein-3+, DB Treatment Period, n=182, 181
    1
    0
        Urine Protein-Neg, Follow-up Period, n=180, 186
    156
    155
        Urine Protein-Tr, Follow-up Period, n=180, 186
    16
    22
        Urine Protein-1+, Follow-up Period, n=180, 186
    6
    8
        Urine Ketones-2+, Follow-up Period, n=180, 186
    1
    1
        Urine Ketones-3+, Follow-up Period, n=180, 186
    1
    0
    Notes
    [29] - ITT Population
    [30] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated urinalysis results for urine occult blood (OB) and the urine leukocyte esterase test (LET)

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    End point title
    		 Number of participants with the indicated urinalysis results for urine occult blood (OB) and the urine leukocyte esterase test (LET)
    End point description
    Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    233 [31]
    229 [32]
    Units: Participants
        Urine OB-Neg, Baseline Period, n=233, 229
    226
    226
        Urine OB-Small, Baseline Period, n=233, 229
    1
    0
        Urine OB-Moderate, Baseline Period, n=233, 229
    1
    0
        Urine OB-Trace, Baseline Period, n=233, 229
    4
    3
        Urine OB-1+, Baseline Period, n=233, 229
    1
    0
        Urine OB-Neg, DB Treatment Period, n=182, 181
    178
    178
        Urine OB-Trace, DB Treatment Period, n=182, 181
    4
    1
        Urine OB-1+, DB Treatment Period, n=182, 181
    0
    1
        Urine OB-3+, DB Treatment Period, n=182, 181
    0
    1
        Urine OB-Neg, Follow-up Period, n=180, 186
    177
    184
        Urine OB-Trace, Follow-up Period, n=180, 186
    1
    1
        Urine OB-1+, Follow-up Period, n=180, 186
    2
    0
        Urine OB-2+, Follow-up Period, n=180, 186
    0
    1
        Urine LET-Neg, Baseline Period, n=233, 229
    220
    219
        Urine LET-Small, Baseline Period, n=233, 229
    1
    2
        Urine LET-Moderate, Baseline Period, n=233, 229
    0
    1
        Urine LET-Large, Baseline Period, n=233, 229
    0
    1
        Urine LET-Trace, Baseline Period, n=233, 229
    7
    0
        Urine LET-1+, Baseline Period, n=233, 229
    3
    2
        Urine LET-2+, Baseline Period, n=233, 229
    0
    2
        Urine LET-3+, Baseline Period, n=233, 229
    2
    2
        Urine LET-Neg, DB Treatment Period, n=182, 181
    170
    163
        Urine LET-Trace, DB Treatment Period, n=182, 181
    5
    4
        Urine LET-1+, DB Treatment Period, n=182, 181
    5
    6
        Urine LET-2+, DB Treatment Period, n=182, 181
    2
    7
        Urine LET-3+, DB Treatment Period, n=182, 181
    0
    1
        Urine LET-Neg, Follow-up Period, n=180, 186
    162
    167
        Urine LET-Trace, Follow-up Period, n=180, 186
    5
    5
        Urine LET-1+, Follow-up Period, n=180, 186
    2
    8
        Urine LET-2+, Follow-up Period, n=180, 186
    8
    4
        Urine LET-3+, Follow-up Period, n=180, 186
    3
    2
    Notes
    [31] - ITT Population
    [32] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated urinalysis results for urine appearance (App.)/clarity and color

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    End point title
    		 Number of participants with the indicated urinalysis results for urine appearance (App.)/clarity and color
    End point description
    Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine). Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)
    End point values
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Number of subjects analysed
    233 [33]
    229 [34]
    Units: Participants
        Urine App.-Clear, Baseline Period, n=233, 229
    188
    197
        Urine App.-Cloudy, Baseline Period, n=233, 229
    23
    21
        Urine App.-Turbid, Baseline Period, n=233, 229
    22
    11
        Urine App.-Clear, DB Treatment Period, n=182, 181
    134
    139
        Urine App.-Cloudy, DB Treatment Period, n=182, 181
    31
    33
        Urine App.-Turbid, DB Treatment Period, n=182, 181
    17
    9
        Urine App.-Clear, Follow-up Period, n=180, 186
    139
    137
        Urine App.-Cloudy, Follow-up Period, n=180, 186
    25
    35
        Urine App.-Turbid, Follow-up Period, n=180, 186
    16
    14
        Urine Color-Straw, Baseline Period, n=233, 229
    8
    8
        Urine Color-Yellow, Baseline Period, n=233, 229
    214
    213
        Urine Color-DY, Baseline Period, n=233, 229
    11
    8
        Urine Color-Straw, DB Treatment Period, n=182, 181
    6
    7
        Urine Color-Yellow, DB Treatment Period, n=182,181
    154
    155
        Urine Color-DY, DB Treatment Period, n=182, 181
    22
    19
        Urine Color-Straw, Follow-up Period, n=180, 186
    6
    7
        Urine Color-Yellow, Follow-up Period, n=180, 186
    156
    160
        Urine Color-DY, Follow-up Period, n=180, 186
    18
    19
    Notes
    [33] - ITT Population
    [34] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Post-randomization adverse events include those that occurred on or after the randomization date.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Placebo: Double-blind Treatment Period
    Reporting group description
    		 Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

    Reporting group title
    FFNS 110 mcg: Double-blind Treatment Period
    Reporting group description
    		 Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

    Serious adverse events
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 237 (1.69%)
    2 / 237 (0.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 237 (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
    Myositis
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo: Double-blind Treatment Period FFNS 110 mcg: Double-blind Treatment Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    147 / 237 (62.03%)
    140 / 237 (59.07%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 237 (2.53%)
    8 / 237 (3.38%)
         occurrences all number
    20
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    15 / 237 (6.33%)
    23 / 237 (9.70%)
         occurrences all number
    21
    25
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    5 / 237 (2.11%)
    2 / 237 (0.84%)
         occurrences all number
    6
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 237 (1.69%)
    5 / 237 (2.11%)
         occurrences all number
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    10 / 237 (4.22%)
    7 / 237 (2.95%)
         occurrences all number
    13
    8
    Cough
         subjects affected / exposed
    16 / 237 (6.75%)
    14 / 237 (5.91%)
         occurrences all number
    25
    20
    Epistaxis
         subjects affected / exposed
    24 / 237 (10.13%)
    17 / 237 (7.17%)
         occurrences all number
    34
    22
    Oropharyngeal pain
         subjects affected / exposed
    6 / 237 (2.53%)
    7 / 237 (2.95%)
         occurrences all number
    8
    8
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    13 / 237 (5.49%)
    3 / 237 (1.27%)
         occurrences all number
    15
    3
    Acute tonsillitis
         subjects affected / exposed
    7 / 237 (2.95%)
    8 / 237 (3.38%)
         occurrences all number
    9
    10
    Bronchitis
         subjects affected / exposed
    28 / 237 (11.81%)
    36 / 237 (15.19%)
         occurrences all number
    48
    64
    Ear infection
         subjects affected / exposed
    2 / 237 (0.84%)
    7 / 237 (2.95%)
         occurrences all number
    2
    7
    Gastroenteritis
         subjects affected / exposed
    4 / 237 (1.69%)
    9 / 237 (3.80%)
         occurrences all number
    4
    10
    Gastroenteritis viral
         subjects affected / exposed
    9 / 237 (3.80%)
    3 / 237 (1.27%)
         occurrences all number
    9
    3
    Influenza
         subjects affected / exposed
    9 / 237 (3.80%)
    15 / 237 (6.33%)
         occurrences all number
    10
    16
    Nasopharyngitis
         subjects affected / exposed
    45 / 237 (18.99%)
    37 / 237 (15.61%)
         occurrences all number
    75
    62
    Otitis media
         subjects affected / exposed
    8 / 237 (3.38%)
    6 / 237 (2.53%)
         occurrences all number
    8
    6
    Otitis media acute
         subjects affected / exposed
    7 / 237 (2.95%)
    5 / 237 (2.11%)
         occurrences all number
    7
    8
    Pharyngitis
         subjects affected / exposed
    19 / 237 (8.02%)
    12 / 237 (5.06%)
         occurrences all number
    22
    16
    Sinusitis
         subjects affected / exposed
    14 / 237 (5.91%)
    12 / 237 (5.06%)
         occurrences all number
    16
    14
    Tonsillitis
         subjects affected / exposed
    7 / 237 (2.95%)
    8 / 237 (3.38%)
         occurrences all number
    7
    8
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 237 (5.06%)
    15 / 237 (6.33%)
         occurrences all number
    14
    18
    Urinary tract infection
         subjects affected / exposed
    3 / 237 (1.27%)
    7 / 237 (2.95%)
         occurrences all number
    4
    7
    Viral pharyngitis
         subjects affected / exposed
    5 / 237 (2.11%)
    3 / 237 (1.27%)
         occurrences all number
    6
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    6 / 237 (2.53%)
    3 / 237 (1.27%)
         occurrences all number
    6
    3
    Respiratory tract infection viral
         subjects affected / exposed
    16 / 237 (6.75%)
    13 / 237 (5.49%)
         occurrences all number
    21
    13
    Respiratory tract infection
         subjects affected / exposed
    7 / 237 (2.95%)
    4 / 237 (1.69%)
         occurrences all number
    8
    4
    H1N1 influenza
         subjects affected / exposed
    6 / 237 (2.53%)
    3 / 237 (1.27%)
         occurrences all number
    6
    3

    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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    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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