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    Clinical Trial Results:
    A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma

    Summary
    EudraCT number
    		 2011-001643-79
    Trial protocol
    		 HU   GB   LV   CZ   LT   ES   AT   SE   BE   DK   NL   BG   IT   FI   SK   DE  
    Global end of trial date
    03 Nov 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Nov 2016
    First version publication date
    15 May 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Changes required per study team changes to the ctgov summary to get summaries consistent.

    Trial information

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    Trial identification
    Sponsor protocol code
    SAS115358
    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
    Final
    Date of interim/final analysis
    15 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate whether the addition of a long-acting beta-adrenoceptor agonist (LABA) to an inhaled corticosteroid (ICS) (Fluticasone propionate/salmeterol combination [FSC]) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS alone (Fluticasone Propionate [FP]) in pediatric subjects (age 4-11 years) with persistent asthma.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2011
    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
    Canada: 97
    Country: Number of subjects enrolled
    United States: 2796
    Country: Number of subjects enrolled
    Argentina: 251
    Country: Number of subjects enrolled
    Chile: 151
    Country: Number of subjects enrolled
    Mexico: 38
    Country: Number of subjects enrolled
    Peru: 220
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Bulgaria: 252
    Country: Number of subjects enrolled
    Croatia: 45
    Country: Number of subjects enrolled
    Czech Republic: 24
    Country: Number of subjects enrolled
    Germany: 52
    Country: Number of subjects enrolled
    Hungary: 132
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Latvia: 70
    Country: Number of subjects enrolled
    Lithuania: 15
    Country: Number of subjects enrolled
    Poland: 299
    Country: Number of subjects enrolled
    Romania: 8
    Country: Number of subjects enrolled
    Russian Federation: 271
    Country: Number of subjects enrolled
    Serbia: 131
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Ukraine: 177
    Country: Number of subjects enrolled
    United Kingdom: 33
    Country: Number of subjects enrolled
    South Africa: 700
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 99
    Country: Number of subjects enrolled
    Malaysia: 82
    Country: Number of subjects enrolled
    Philippines: 52
    Country: Number of subjects enrolled
    Taiwan: 93
    Country: Number of subjects enrolled
    Thailand: 70
    Worldwide total number of subjects
    6250
    EEA total number of subjects
    997
    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)
    6249
    Adolescents (12-17 years)
    1
    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
    		 A total of 6250 participants were enrolled and randomized to study treatments; total 6208 participants took at least one dose of study drug.

    Pre-assignment
    Screening details
    		 Participants aged between 4 to 11 years having asthma, defined by the regional asthma guidelines for at least 6 months, having history of at least one occurrence of treatment with systemic corticosteroid and with no change in asthma therapy for the last 4 weeks from first visit were enrolled for the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluticasone propionate/salmeterol combination (FSC)
    Arm description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Propionate 100 micrograms (μg) and salmeterol 50 μg inhalation powder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    1 inhalation twice daily (morning and evening) via dry powder inhaler

    Investigational medicinal product name
    Fluticasone Propionate 250 μg and salmeterol 50 μg inhalation powder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    1 inhalation twice daily (morning and evening) via dry powder inhaler

    Arm title
    		 Fluticasone propionate (FP)
    Arm description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone Propionate 100 μg inhalation powder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    1 inhalation twice daily (morning and evening) via dry powder inhaler

    Investigational medicinal product name
    Fluticasone Propionate 250 μg inhalation powder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    1 inhalation twice daily (morning and evening) via dry powder inhaler

    Number of subjects in period 1 [1]
    		Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Started
    3107
    3101
    Completed
    2724
    2751
    Not completed
    383
    350
         Consent withdrawn by subject
    245
    226
         Asthma Exacerbation
    34
    35
         Adverse event, non-fatal
    24
    23
         Lost to follow-up
    7
    7
         Lack of efficacy
    5
    6
         Protocol deviation
    68
    53
    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: The worldwide number enrolled was calculated from the 'Randomization Population', and included participants who were randomized to but never used study treatment whereas the number of subjects reported to be in the baseline period represents the 'Intent-to-Treat Population' which included only those randomized participants who took study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol combination (FSC)
    Reporting group description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.

    Reporting group title
    Fluticasone propionate (FP)
    Reporting group description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.

    Reporting group values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP) Total
    Number of subjects
    		 3107 3101 6208
    Age categorical
    Units: Subjects
    Age continuous
    Population: Randomization
    Units: years
        arithmetic mean (standard deviation)
    		 7.6 ± 2.21 7.6 ± 2.2 -
    Gender categorical
    Units: Subjects
        Female
    		 1187 1227 2414
        Male
    		 1920 1874 3794
    Race, Customized
    Units: Subjects
        African American / African Heritage
    		 539 511 1050
        American Indian or Alaskan Native
    		 144 118 262
        Asian - Central / South Asian Heritage
    		 30 37 67
        Asian - East Asian Heritage
    		 96 112 208
        Japanese Heritage
    		 1 0 1
        Asian - South East Asian Heritage
    		 122 108 230
        Native Hawaiian or Other Pacific Islander
    		 5 1 6
        White - Arabic / North African Heritage
    		 13 15 28
        White - White / Caucasian / European Heritage
    		 1985 2017 4002
        Mixed Race
    		 167 180 347
        Missing
    		 5 2 7

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol combination (FSC)
    Reporting group description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.

    Reporting group title
    Fluticasone propionate (FP)
    Reporting group description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.

    Primary: Number of participants experiencing an event in the composite safety endpoint of serious asthma outcomes (asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death)

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    End point title
    		 Number of participants experiencing an event in the composite safety endpoint of serious asthma outcomes (asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death)
    End point description
    Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    3107 [1]
    3101 [2]
    Units: Participants
    27
    21
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Estimated for Hazard ratio
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    6208
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.006
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.285
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.726
         upper limit
    		 2.272
    Notes
    [3] - The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value <0.025.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Estimated for Absolute risk difference
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    6208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.0019
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0024
         upper limit
    		 0.0063

    Primary: Number of participants with at least one asthma exacerbation over the 6-month study treatment period

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    End point title
    		 Number of participants with at least one asthma exacerbation over the 6-month study treatment period
    End point description
    Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    3107 [4]
    3101 [5]
    Units: Participants
    265
    309
    Notes
    [4] - mITT Population
    [5] - mITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol combination (FSC) v Fluticasone propionate (FP)
    Number of subjects included in analysis
    6208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.859
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Number of participants experiencing asthma-related deaths over the 6-month study treatment period

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    End point title
    		 Number of participants experiencing asthma-related deaths over the 6-month study treatment period
    End point description
    Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    3107 [6]
    3101 [7]
    Units: Participants
    0
    0
    Notes
    [6] - ITT Population
    [7] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period

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    End point title
    		 Number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period
    End point description
    Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    3107 [8]
    3101 [9]
    Units: Participants
    0
    0
    Notes
    [8] - ITT Population
    [9] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period

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    End point title
    		 Number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period
    End point description
    Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    3107 [10]
    3101 [11]
    Units: Participants
    27
    21
    Notes
    [10] - ITT Population
    [11] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period

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    End point title
    		 Number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period
    End point description
    An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    265 [12]
    309 [13]
    Units: Participants
    33
    35
    Notes
    [12] - mITT Population
    [13] - mITT Population
    No statistical analyses for this end point

    Secondary: Percentage of rescue-free days over the 6-month study treatment period

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    End point title
    		 Percentage of rescue-free days over the 6-month study treatment period
    End point description
    Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    3049 [14]
    3036 [15]
    Units: Percentage of rescue-free days
        arithmetic mean (standard error)
    83 ± 0.5
    81.9 ± 0.52
    Notes
    [14] - mITT Population
    [15] - mITT Population
    No statistical analyses for this end point

    Secondary: Percentage of asthma control days over the 6-month study treatment period

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    End point title
    		 Percentage of asthma control days over the 6-month study treatment period
    End point description
    An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months
    End point values
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Number of subjects analysed
    2936 [16]
    2935 [17]
    Units: Percentage of asthma control days
        arithmetic mean (standard error)
    74.8 ± 0.57
    73.4 ± 0.58
    Notes
    [16] - mITT Population
    [17] - mITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
    Adverse event reporting additional description
    Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol combination (FSC)
    Reporting group description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.

    Reporting group title
    Fluticasone propionate (FP)
    Reporting group description
    		 Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.

    Serious adverse events
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    56 / 3107 (1.80%)
    54 / 3101 (1.74%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Effusion
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    23 / 3107 (0.74%)
    13 / 3101 (0.42%)
         occurrences causally related to treatment / all
    4 / 23
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 3107 (0.03%)
    2 / 3101 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative fever
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt malfunction
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3107 (0.00%)
    2 / 3101 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Henoch-Schonlein purpura
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract disorder
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Synovitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    11 / 3107 (0.35%)
    8 / 3101 (0.26%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 3107 (0.10%)
    2 / 3101 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 3107 (0.03%)
    2 / 3101 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 3107 (0.00%)
    2 / 3101 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    2 / 3101 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bullous impetigo
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudocroup
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         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
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral myositis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral tonsillitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic disorder
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         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: 0%
    Non-serious adverse events
    		 Fluticasone propionate/salmeterol combination (FSC) Fluticasone propionate (FP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 3107 (1.00%)
    39 / 3101 (1.26%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 3107 (0.06%)
    2 / 3101 (0.06%)
         occurrences all number
    2
    2
    Tremor
         subjects affected / exposed
    2 / 3107 (0.06%)
    0 / 3101 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Eye disorders
    Eye swelling
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    15 / 3107 (0.48%)
    23 / 3101 (0.74%)
         occurrences all number
    15
    23
    Cough
         subjects affected / exposed
    2 / 3107 (0.06%)
    2 / 3101 (0.06%)
         occurrences all number
    2
    2
    Wheezing
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences all number
    1
    1
    Bronchospasm
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Pharyngeal inflammation
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences all number
    1
    1
    Eczema
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Pityriasis rosea
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 3107 (0.06%)
    0 / 3101 (0.00%)
         occurrences all number
    2
    0
    Irritability
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences all number
    1
    1
    Abnormal behaviour
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 3107 (0.03%)
    1 / 3101 (0.03%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 3107 (0.06%)
    0 / 3101 (0.00%)
         occurrences all number
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3107 (0.00%)
    1 / 3101 (0.03%)
         occurrences all number
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 3107 (0.03%)
    0 / 3101 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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