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    Clinical Trial Results:
    Clinical assessment of fluticasone propionate/ salmeterol xinafoate HFA MDI in 6-month to 4-year-old Japanese patients with bronchial asthma

    Summary
    EudraCT number
    		 2016-003479-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    21 Dec 2016
    First version publication date
    21 Dec 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    200860
    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?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    17 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2016
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of fluticasone propionate (FP)/ salmeterol xinafoate (SLM) hydrofluoroalkane (HFA) MDI 50/25 µg 1 or 2 inhalation bid for 8 weeks in comparison with FP HFA MDI 50 µg 1 or 2 inhalation bid in 6-month to 4-year-old Japanese patients with bronchial asthma.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 May 2014
    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
    Japan: 370
    Worldwide total number of subjects
    370
    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)
    67
    Children (2-11 years)
    303
    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
    		 This study evaluated the efficacy and safety of (FP)/salmeterol xinafoate (SLM) HFA twice-daily (BID) via metered-dose inhaler (MDI) for 8 weeks in comparison with FP HFA MDI in 6-months to 4-years-old Japanese participants (par.) with infantile bronchial asthma. The results presented are based on the Interim Analysis.

    Pre-assignment
    Screening details
    		 Eligible par. at screening entered a 2-week run-in period to receive FP HFA MDI 50 µg, followed by 8-week double-blind treatment period (TP) 1 to receive FP/SLM HFA MDI 50/25 µg or FP HFA MDI 50 µg. In TP2, par. received FP/SLM HFA MDI 50/25 µg for 16 weeks (open-label phase). The total duration of the study was 27 weeks with follow-up.

    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
    		 FP HFA 50 µg
    Arm description
    		 In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate (FP) HFA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    FP HFA was administered via pressurized Metered-Dose Inhaler at 50 µg BID (one or two inhalations given using AeroChamber Plus with face mask) for 2 weeks in run-in period and 8 weeks in TP1

    Arm title
    		 FP/SLM HFA 50/25 µg
    Arm description
    		 In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone propionate (FP)/salmeterol xinafoate (SLM) HFA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    FP/SLM HFA was administered via pressurized Metered-Dose Inhaler at 50/25µg BID (one or two inhalations given using AeroChamber Plus with face mask) for 8 weeks in TP1 and 16 weeks in TP2

    Number of subjects in period 1 [1]
    		FP HFA 50 µg FP/SLM HFA 50/25 µg
    Started
    150
    150
    Completed
    142
    148
    Not completed
    8
    2
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Par. Reached Stopping Criteria
    5
    2
         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 370 participants were enrolled of which 300 participants were randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FP HFA 50 µg
    Reporting group description
    		 In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.

    Reporting group title
    FP/SLM HFA 50/25 µg
    Reporting group description
    		 In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.

    Reporting group values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg Total
    Number of subjects
    		 150 150
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: months
        arithmetic mean (standard deviation)
    		 38.4 ( 14.1 ) 40.5 ( 14.07 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 60 55 115
        Male
    		 90 95 185
    Race/Ethnicity, Customized
    Units: Subjects
        Asian - Japanese Heritage
    		 150 150 300

    End points

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    End points reporting groups
    Reporting group title
    FP HFA 50 µg
    Reporting group description
    		 In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.

    Reporting group title
    FP/SLM HFA 50/25 µg
    Reporting group description
    		 In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.

    Primary: Mean change from Baseline in total asthma symptom score (daytime plus night time) at the end of the Treatment Period 1 (TP1)

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    End point title
    		 Mean change from Baseline in total asthma symptom score (daytime plus night time) at the end of the Treatment Period 1 (TP1)
    End point description
    The participant’s parent or legally acceptable representative made entries asthma symptom experienced by the participant in a patient diary twice daily (day time and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]).The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    142 [1]
    148 [2]
    Units: Scores on a scale
        least squares mean (standard error)
    -3.01 ( 0.545 )
    -3.97 ( 0.534 )
    Notes
    [1] - ITT Population: all randomized par. who received at least one dose of study medication.
    [2] - ITT Population: all randomized par. who received at least one dose of study medication.
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP HFA 50 µg v FP/SLM HFA 50/25 µg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.206
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least square means
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.47
         upper limit
    		 0.54

    Secondary: Mean change from Baseline in night-time asthma symptoms score at the end of Treatment Period 1 (TP1)

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    End point title
    		 Mean change from Baseline in night-time asthma symptoms score at the end of Treatment Period 1 (TP1)
    End point description
    The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the night in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 (none) to 3 (severe). Change from Baseline in the asthma symptom scores at night time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]).The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    142 [3]
    148 [4]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.61 ( 0.292 )
    -2.1 ( 0.286 )
    Notes
    [3] - ITT Population
    [4] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP/SLM HFA 50/25 µg v FP HFA 50 µg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.235
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least sqaure means
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 0.32

    Secondary: Mean change from Baseline in daytime asthma symptoms score at the end of Treatment Period 1 (TP1)

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    End point title
    		 Mean change from Baseline in daytime asthma symptoms score at the end of Treatment Period 1 (TP1)
    End point description
    The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the day in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 (none) to 3 (severe). Change from Baseline in the asthma symptom scores at day time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]).The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    142 [5]
    148 [6]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.39 ( 0.287 )
    -1.87 ( 0.281 )
    Notes
    [5] - ITT Population
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP HFA 50 µg v FP/SLM HFA 50/25 µg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.236
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least-Sqaure means
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 0.31

    Secondary: Number of participants with at least one asthma exacerbation in Treatment Period 1 (TP1)

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    End point title
    		 Number of participants with at least one asthma exacerbation in Treatment Period 1 (TP1)
    End point description
    The definition of exacerbations was amended during the study. <Original> An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral, or depot) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. <Amendment> An asthma exacerbation is defined as deterioration of asthma requiring the use of prednisone or hydrocortisone equivalent systemic corticosteroids for at least 3 days, or requiring the use of dexamethasone or betametasone equivalent systemic corticosteroids (oral, intravenous or intramuscular), or requiring the use of systemic depot corticosteroids once, or an in-patient hospitalization that required treatment for respiratory symptom with wheezing, or emergency department visit due to asthma that required intravenous systemic corticosteroids.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    147 [7]
    150 [8]
    Units: Participants
    8
    4
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP/SLM HFA 50/25 µg v FP HFA 50 µg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 1.6

    Secondary: Mean change from Baseline in Japanese Pediatric Asthma Control Program (JPAC) score at the end of Treatment Period 1 (TP1)

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    End point title
    		 Mean change from Baseline in Japanese Pediatric Asthma Control Program (JPAC) score at the end of Treatment Period 1 (TP1)
    End point description
    Severity and control statuses based on Japanese pediatric guideline for the treatment and management of asthma (JPGL) can be assessed according to JPAC. Theoretically range of JPAC score was 0 (poor control) to 18 (complete control) point. JPAC questionnaire was recorded at Baseline (Week -2) and Week 8 by the participant's parent or legally acceptable representative who knew the participant's asthma for the last month. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    142 [9]
    148 [10]
    Units: Scores on a scale
        least squares mean (standard error)
    -0.3 ( 0.25 )
    0.4 ( 0.24 )
    Notes
    [9] - ITT Population
    [10] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP HFA 50 µg v FP/SLM HFA 50/25 µg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.041
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least-Square Means
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1.4

    Secondary: Change from Baseline in use of rescue medication (number of occasions used during a 24-hour period) in Treatment Period 1 (TP1)

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    End point title
    		 Change from Baseline in use of rescue medication (number of occasions used during a 24-hour period) in Treatment Period 1 (TP1)
    End point description
    The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary from Baseline (Week -1) until Week 8. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8 weeks in TP1 were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    142 [11]
    148 [12]
    Units: Occasions per 24 hours
        least squares mean (standard error)
    0.07 ( 0.048 )
    0.01 ( 0.047 )
    Notes
    [11] - ITT Population
    [12] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP/SLM HFA 50/25 µg v FP HFA 50 µg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.335
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.07

    Secondary: Change from Baseline in use of rescue medication (percentage of days with rescue-free 24-hour period) at the end of Treatment Period 1 (TP1)

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    End point title
    		 Change from Baseline in use of rescue medication (percentage of days with rescue-free 24-hour period) at the end of Treatment Period 1 (TP1)
    End point description
    The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 8 weeks in TP1 minus the value at Baseline. Participants who completed TP1 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 FP HFA 50 µg FP/SLM HFA 50/25 µg
    Number of subjects analysed
    142 [13]
    148 [14]
    Units: Percentage of rescue-free 24-hour period
        least squares mean (standard error)
    -2.9 ( 2.16 )
    -0.3 ( 2.11 )
    Notes
    [13] - ITT Population
    [14] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP HFA 50 µg v FP/SLM HFA 50/25 µg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.389
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 8.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All on-treatment serious adverse events (SAEs) and non-serious AEs were collected in Treatment Period 1.
    Adverse event reporting additional description
    On-treatment AEs and SAEs are reported for the ITT Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    FP/SLM HFA 50/25 µg
    Reporting group description
    		 In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.

    Reporting group title
    FP HFA 50 µg
    Reporting group description
    		 In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.

    Serious adverse events
    		 FP/SLM HFA 50/25 µg FP HFA 50 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 150 (0.67%)
    5 / 150 (3.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 150 (0.00%)
    4 / 150 (2.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 150 (0.67%)
         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
    		 FP/SLM HFA 50/25 µg FP HFA 50 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 150 (53.33%)
    82 / 150 (54.67%)
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    10 / 150 (6.67%)
    18 / 150 (12.00%)
         occurrences all number
    13
    25
    Asthma
         subjects affected / exposed
    4 / 150 (2.67%)
    10 / 150 (6.67%)
         occurrences all number
    4
    10
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    28 / 150 (18.67%)
    17 / 150 (11.33%)
         occurrences all number
    35
    19
    Nasopharyngitis
         subjects affected / exposed
    18 / 150 (12.00%)
    24 / 150 (16.00%)
         occurrences all number
    22
    33
    Bronchitis
         subjects affected / exposed
    14 / 150 (9.33%)
    13 / 150 (8.67%)
         occurrences all number
    18
    15
    Gastroenteritis
         subjects affected / exposed
    11 / 150 (7.33%)
    13 / 150 (8.67%)
         occurrences all number
    14
    13
    Pharyngitis
         subjects affected / exposed
    11 / 150 (7.33%)
    9 / 150 (6.00%)
         occurrences all number
    14
    12
    Hand-foot-and-mouth disease
         subjects affected / exposed
    9 / 150 (6.00%)
    4 / 150 (2.67%)
         occurrences all number
    9
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2015
    The primary purpose of this amendment is to change the wording related to the definition of inclusion criteria, re-screening criteria, permitted medications and non- drug therapies, prohibited medications and non-drug therapies, asthma exacerbation, withdrawal criteria and rescue medication and to clarify ambiguous description based on the comments from Safety Review Team.
    26 Jan 2016
    The primary objectives of this amendment is to set up interim analyses with the view to posting and disclosing study result summary on the clinical trial registries within 6 months after primary compression achievement of the last subject, change administrative aspects of the trail, and make adjustments to ambiguous descriptions.

    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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