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    Clinical Trial Results:
    A multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate 1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma

    Summary
    EudraCT number
    		 2015-004870-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jun 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2016
    First version publication date
    25 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LOC114220
    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 Clinical Support Help Desk, GlaxoSmithKline Research & Development Ltd, +44 08007839733, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Clinical Support Help Desk, GlaxoSmithKline Research & Development Ltd, +44 08007839733, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy and safety of nebulized fluticasone propionated 1mg BID compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbatio of asthma.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 266
    Worldwide total number of subjects
    266
    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)
    259
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study consisted of two periods: treatment period (7 days) and follow-up period (14 days). The total participation time in the study from Visit 1 (day of presentation to the clinic or emergency department with an acute exacerbation of asthma) to Visit 4 (follow-up phone contact) was approximately 21 days.

    Pre-assignment
    Screening details
    		 A total of 261 participants (par.) who presented to the clinical or emergency department with an acute exacerbation of asthma were enrolled in the study. A total of 251 participants received at least a single dose of investigational products (IP).

    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, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluticasone propionate
    Arm description
    		 Participants received fluticasone propionate (FP) inhalation solution twice daily 2x0.5 milligrams (mg)/milliliters (mL) via a nebulizer in morning and evening for 7 days. Participants also received placebo tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Propionate Nebules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    2x0.5 mg/2mL twice daily via nebulization in morning and evening for 7 days

    Investigational medicinal product name
    Dummy tablet placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo soluble tablets once daily in the morning for 7 days.

    Arm title
    		 Prednisone
    Arm description
    		 Participants received oral prednisone (Pred) tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Participants also received placebo nebules 2×2mL 0.9% saline twice daily (in morning and evening) for 7 days. Salbutamol was provided on an needed basis throughout the treatment period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisone Tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 mg per kg per day once daily, up to 40mg per day for 4 Days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in morning.

    Investigational medicinal product name
    Dummy nebules placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    2×2mL 0.9% saline twice daily for 7 Days in morning and evening

    Number of subjects in period 1 [1]
    		Fluticasone propionate Prednisone
    Started
    123
    128
    Completed
    116
    123
    Not completed
    7
    5
         Consent withdrawn by subject
    6
    3
         Lack of efficacy
    1
    1
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 266 subjects were screened for this study. A total of 261 participants (par.) who presented to the clinical or emergency department with an acute exacerbation of asthma were enrolled in the study. A total of 251 participants received at least a single dose of investigational products (IP).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone propionate
    Reporting group description
    		 Participants received fluticasone propionate (FP) inhalation solution twice daily 2x0.5 milligrams (mg)/milliliters (mL) via a nebulizer in morning and evening for 7 days. Participants also received placebo tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.

    Reporting group title
    Prednisone
    Reporting group description
    		 Participants received oral prednisone (Pred) tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Participants also received placebo nebules 2×2mL 0.9% saline twice daily (in morning and evening) for 7 days. Salbutamol was provided on an needed basis throughout the treatment period.

    Reporting group values
    		 Fluticasone propionate Prednisone Total
    Number of subjects
    		 123 128 251
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.6 ( 2.41 ) 6.5 ( 2.32 ) -
    Gender categorical
    Units: Subjects
        Female
    		 51 51 102
        Male
    		 72 77 149
    Race, Customized
    Units: Subjects
        Asian - East Asian Heritage
    		 123 128 251

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone propionate
    Reporting group description
    		 Participants received fluticasone propionate (FP) inhalation solution twice daily 2x0.5 milligrams (mg)/milliliters (mL) via a nebulizer in morning and evening for 7 days. Participants also received placebo tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.

    Reporting group title
    Prednisone
    Reporting group description
    		 Participants received oral prednisone (Pred) tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Participants also received placebo nebules 2×2mL 0.9% saline twice daily (in morning and evening) for 7 days. Salbutamol was provided on an needed basis throughout the treatment period.

    Primary: Mean morning (AM) peak expiratory flow (PEF) on diary card over the treatment assessment period (ITT Population)

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    End point title
    		 Mean morning (AM) peak expiratory flow (PEF) on diary card over the treatment assessment period (ITT Population)
    End point description
    PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Par. (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study medication. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The endpoint was considered missing if less than 2 days were recorded in the given treatment assessment period. Two par. from fluticasone propionate group and 4 par. from prednisone group had the missing endpoint. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, center and treatment group. Intent-to-Treat (ITT) Population: all par. randomized to treatment and who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Days 2 to 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    121 [1]
    124 [2]
    Units: Liters per minute
        least squares mean (standard error)
    188.77 ( 3.774 )
    188.31 ( 3.79 )
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.931
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.85
         upper limit
    		 10.76

    Primary: Mean morning (AM) peak expiratory flow (PEF) on diary card over the treatment assessment period (PP Population)

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    End point title
    		 Mean morning (AM) peak expiratory flow (PEF) on diary card over the treatment assessment period (PP Population)
    End point description
    PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Par. (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study medication. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The endpoint was considered missing if less than 2 days were recorded in the given treatment assessment period. Two par. from fluticasone propionate group and 5 par. from prednisone group had the missing endpoint. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, center and treatment group. Per Protocol (PP) Population: all par. in the ITT Population who did not have any full protocol deviations.
    End point type
    Primary
    End point timeframe
    Days 2 to 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    114 [3]
    120 [4]
    Units: Liters per minute
        least squares mean (standard error)
    189.46 ( 3.724 )
    188.96 ( 3.712 )
    Notes
    [3] - PP Population
    [4] - PP Population
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.922
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.64
         upper limit
    		 10.65

    Secondary: Mean evening (PM) PEF on diary card over the treatment assessment period

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    End point title
    		 Mean evening (PM) PEF on diary card over the treatment assessment period
    End point description
    PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Par. recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00PM) before taking any study medication. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If par. started to take the study drug in the morning (early or on 12:00 PM), only then the PM PEF on the date of randomization was used. If par. started to take the study drug in the afternoon (later than 12:00 PM), then PM PEF on the date of randomization was not used.The endpoint was considered missing if less than 2 days was recorded in the given treatment assessment period. Two par. from fluticasone propionate group and 5 par. from prednisone group had the missing endpoint. Analysis was performed using an ANCOVA model with effects due to gender, age, center and treatment group.
    End point type
    Secondary
    End point timeframe
    Days 1/2 to 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    121 [5]
    123 [6]
    Units: Liters per minute
        least squares mean (standard error)
    195.79 ( 3.723 )
    194.63 ( 3.751 )
    Notes
    [5] - ITT Population
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.822
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.02
         upper limit
    		 11.34

    Secondary: Median day-time and night-time symptom scores over the treatment assessment period

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    End point title
    		 Median day-time and night-time symptom scores over the treatment assessment period
    End point description
    The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on par. diary cards. Day time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The endpoints were considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Days 2 to 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    123 [7]
    128 [8]
    Units: Scores on a scale
    median (full range (min-max))
        Daytime symptom score, n=121, 123
    0.5 (0 to 3)
    1 (0 to 3)
        Nighttime symptom score, n=121, 124
    0 (0 to 3)
    0 (0 to 4)
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    		 For median daytime symptom score
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.717
    Method
    		 Wilcoxon rank sum test
    Confidence interval
    Statistical analysis title
    		 For median night time symptom score
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.683
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Median number of use of rescue medications during day and night over the treatment assessment period

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    End point title
    		 Median number of use of rescue medications during day and night over the treatment assessment period
    End point description
    The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The endpoint was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.
    End point type
    Secondary
    End point timeframe
    Days 2 to 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    121 [9]
    123 [10]
    Units: Number of use of rescue medication
        median (full range (min-max))
    2 (0 to 3)
    2 (0 to 3)
    Notes
    [9] - ITT Population
    [10] - ITT Population
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.996
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Clinical assessment of lung function during the treatment period

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    End point title
    		 Clinical assessment of lung function during the treatment period
    End point description
    Spirometric assessments of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, center, age and treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    During the treatment period at Day 5, Day 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    123 [11]
    128 [12]
    Units: Liters
    least squares mean (standard error)
        FEV1, Day 5, n=102, 114
    1.288 ( 0.0348 )
    1.331 ( 0.0332 )
        FEV1, Day 8, n=103, 118
    1.4 ( 0.0294 )
    1.396 ( 0.028 )
        FVC, Day 5, n=107, 118
    1.476 ( 0.0454 )
    1.543 ( 0.0439 )
        FVC, Day 8, n=109, 121
    1.544 ( 0.0326 )
    1.582 ( 0.0316 )
    Notes
    [11] - ITT Population
    [12] - ITT Population
    Statistical analysis title
    		 FEV1, Day 5
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.348
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.044
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.135
         upper limit
    		 0.048
    Statistical analysis title
    		 FEV1, Day 8
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.914
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.004
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.074
         upper limit
    		 0.083
    Statistical analysis title
    		 FVC, Day 5
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.276
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.067
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.187
         upper limit
    		 0.054
    Statistical analysis title
    		 FVC, Day 8
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.384
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.039
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.126
         upper limit
    		 0.049

    Secondary: Change from Baseline in Clinical scoring index at Day 5 and Day 8

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    End point title
    		 Change from Baseline in Clinical scoring index at Day 5 and Day 8
    End point description
    The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represents the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters was scored from 0 to 3 where none=0, mild=1, moderate=2, severe=3. The Baseline value was the last non-missing values prior to randomisation. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline, Day 5 and Day 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    123 [13]
    128 [14]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Day 5, n=121, 125
    -2.7 ( 1.41 )
    -2.6 ( 1.44 )
        Day 8, n=116, 123
    -3.4 ( 1.26 )
    -3.4 ( 1.26 )
    Notes
    [13] - ITT Population
    [14] - ITT Population
    Statistical analysis title
    		 Day 5
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.507
    Method
    		 Wilcoxon rank sum test
    Confidence interval
    Statistical analysis title
    		 Day 8
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Participant/parent and investigator global evaluation for efficacy

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    End point title
    		 Participant/parent and investigator global evaluation for efficacy
    End point description
    At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Fluticasone propionate Prednisone
    Number of subjects analysed
    123 [15]
    128 [16]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Participant/parent global evaluation, n=122,128
    1.5 ( 0.59 )
    1.5 ( 0.52 )
        Investigator global evaluation, n=121,128
    1.5 ( 0.56 )
    1.5 ( 0.52 )
    Notes
    [15] - ITT Population
    [16] - ITT Population
    Statistical analysis title
    		 Participant/parent global evaluation
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.633
    Method
    		 Wilcoxon rank sum test
    Confidence interval
    Statistical analysis title
    		 Investigator global evaluation
    Comparison groups
    Fluticasone propionate v Prednisone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.323
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication through the treatment Phase (8 days post-dose) and assessed up to 23 days.
    Adverse event reporting additional description
    Safety Population: comprised of participants randomized to treatment and who received at least one dose of study drug. Participants were assigned to the treatment group as per treatment actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Fluticasone propionate
    Reporting group description
    		 Participants received fluticasone propionate (FP) inhalation solution twice daily 2x0.5 milligrams (mg)/milliliters (mL) via a nebulizer in morning and evening for 7 days. Participants also received placebo tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.

    Reporting group title
    Prednisone
    Reporting group description
    		 Participants received oral prednisone (Pred) tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Participants also received placebo nebules 2×2mL 0.9% saline twice daily (in morning and evening) for 7 days. Salbutamol was provided on an needed basis throughout the treatment period.

    Serious adverse events
    		 Fluticasone propionate Prednisone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 123 (0.81%)
    2 / 128 (1.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 123 (0.81%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fluticasone propionate Prednisone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 123 (3.25%)
    18 / 128 (14.06%)
    Investigations
    White blood cell count increased
         subjects affected / exposed
    1 / 123 (0.81%)
    10 / 128 (7.81%)
         occurrences all number
    1
    10
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 123 (0.81%)
    5 / 128 (3.91%)
         occurrences all number
    1
    5
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 123 (1.63%)
    3 / 128 (2.34%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Apr 2013
    Amendment 01: To amend the dosing time of the Prednisone tablets on the day of randomization

    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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