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    Clinical Trial Results:
    A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once- Daily in Subjects with Asthma

    Summary
    EudraCT number
    		 2009-011461-84
    Trial protocol
    		 DE   Outside EU/EEA  
    Global end of trial date
    15 Sep 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    09 Feb 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HZA106837
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000431-PIP01-08
    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
    24 Nov 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate that treatment with Fluticasone Furoate/GW642444 Inhalation Powder once-daily administered in the evening significantly decreased the risk of severe asthma exacerbations as measured by time to first severe asthma exacerbation when compared with the same dose of Fluticasone Furoate Inhalation Powder alone administered once-daily in the evening in subjects 12 years of age and older with asthma. This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
    Protection of trial subjects
    Participants with life-threatening asthma were not enrolled in the study. Withdrawal of the participant from the trial was required if any of the following criteria were met: participant experienced three severe asthma exacerbations in any 6-month period or four severe asthma exacerbations during the double-blind treatment period; participant became pregnant; participant had an adverse event that would make continued participation in the study an unacceptable risk (in the judgment of the investigator); or liver chemistry threshold criteria were met. An Independent Data Monitoring Committee was utilized to ensure external objective medical and/or statistical review of safety and/or efficacy issues in order to protect the ethical and safety interests of the participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 187
    Country: Number of subjects enrolled
    Romania: 176
    Country: Number of subjects enrolled
    Germany: 236
    Country: Number of subjects enrolled
    Argentina: 187
    Country: Number of subjects enrolled
    Australia: 60
    Country: Number of subjects enrolled
    Philippines: 184
    Country: Number of subjects enrolled
    Russian Federation: 354
    Country: Number of subjects enrolled
    Mexico: 264
    Country: Number of subjects enrolled
    Ukraine: 238
    Country: Number of subjects enrolled
    Japan: 125
    Country: Number of subjects enrolled
    United States: 657
    Worldwide total number of subjects
    2668
    EEA total number of subjects
    599
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    344
    Adults (18-64 years)
    2102
    From 65 to 84 years
    220
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants (par.) who met all entry criteria at Screening entered a 2-week Run-in Period for completion of Baseline safety evaluations and to obtain Baseline measures of asthma status. Participants who met continuation criteria at the end of the Run-in Period were randomized to receive study treatment.

    Period 1
    Period 1 title
    2-week Run-in Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 FP 250 µg/ICS
    Arm description
    		 Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
    Arm type
    		 Unblinded run-in medication

    Investigational medicinal product name
    fluticasone propionate (FP) 250 µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    250 µg, twice daily

    Number of subjects in period 1
    		FP 250 µg/ICS
    Started
    2183
    Completed
    2020
    Not completed
    163
         Physician decision
    6
         Consent withdrawn by subject
    19
         Adverse event, non-fatal
    1
         Continuation Criteria Not Met
    92
         Lost to follow-up
    1
         Study Closed/Terminated
    42
         Protocol deviation
    1
         Randomized in Error
    1
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FF 100 µg
    Arm description
    		 Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    100 micrograms (µg), once daily in the evening

    Arm title
    		 FF/VI 100/25 µg
    Arm description
    		 Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate/vilanterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    100/25 µg, once daily in the evening

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The randomized treatment period is considered to be the baseline period. Subject disposition data are collected for members of the Intent-to-Treat Population, defined as all randomized participants who received at least a single dose of trial medication. Not all participants enrolled in the trial (participants screened and for whom a record exists on the study database) were randomized to treatment.
    Number of subjects in period 2 [2] [3]
    		FF 100 µg FF/VI 100/25 µg
    Started
    1010
    1009
    Intent-to-Treat (ITT) Population
    1010
    1009
    Completed
    863
    885
    Not completed
    147
    124
         Consent withdrawn by subject
    53
    55
         Physician decision
    9
    6
         Adverse event, non-fatal
    19
    15
         Lost to follow-up
    11
    9
         Study Closed/Terminated
    7
    8
         Protocol deviation
    26
    17
         Lack of efficacy
    22
    13
         Protocol-Defined Stopping Criteria
    -
    1
    Notes
    [2] - 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: Subject disposition data are collected for members of the Intent-to-Treat Population, defined as all randomized participants who received at least a single dose of trial medication. Not all participants enrolled in the trial (participants screened and for whom a record exists on the study database) were randomized to treatment.
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One participant who completed the 2-week Run-in Period was not randomised but recieved treatment (fluticasone furoate 100 micrograms) in error. This participant is not included in the Intent-to-Treat (ITT) population. Only those participants comprising the ITT Population started the Treatment Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FF 100 µg
    Reporting group description
    		 Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

    Reporting group title
    FF/VI 100/25 µg
    Reporting group description
    		 Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

    Reporting group values
    		 FF 100 µg FF/VI 100/25 µg Total
    Number of subjects
    		 1010 1009 2019
    Age categorical
    Units: Subjects
    Age continuous
    Baseline characteristic data were collected in members of the Intent-to-Treat Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
    Units: years
        arithmetic mean (standard deviation)
    		 42.3 ± 16.82 41.1 ± 17.1 -
    Gender categorical
    Baseline characteristic data were collected in members of the Intent-to-Treat Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
    Units: Subjects
        Female
    		 689 661 1350
        Male
    		 321 348 669
    Race, customized
    Baseline characteristic data were collected in members of the Intent-to-Treat Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
    Units: Subjects
        African American/African Heritage
    		 47 40 87
        American Indian or Alaska Native
    		 4 9 13
        Asian - Central/South Asian Heritage
    		 0 2 2
        Asian - East Asian Heritage
    		 1 0 1
        Asian - Japanese Heritage
    		 30 32 62
        Asian - South East Asian Heritage
    		 79 78 157
        Native Hawaiian or other Pacific Islander
    		 2 0 2
        White - Arabic/North African Heritage
    		 5 2 7
        White - White/Caucasian/European Heritage
    		 738 738 1476
        Mixed Race
    		 104 108 212

    End points

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    End points reporting groups
    Reporting group title
    FP 250 µg/ICS
    Reporting group description
    		 Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
    Reporting group title
    FF 100 µg
    Reporting group description
    		 Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

    Reporting group title
    FF/VI 100/25 µg
    Reporting group description
    		 Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

    Primary: Number of participants with 1 or more severe asthma exacerbations

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    End point title
    		 Number of participants with 1 or more severe asthma exacerbations
    End point description
    Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.
    End point type
    Primary
    End point timeframe
    Baseline to Follow-up (up to 76 weeks of treatment)
    End point values
    		 FF 100 µg FF/VI 100/25 µg
    Number of subjects analysed
    1010 [1]
    1009 [2]
    Units: participants
    186
    154
    Notes
    [1] - ITT Population: all participants randomized to treatment who received >=1 dose of study medication
    [2] - ITT Population: all participants randomized to treatment who received >=1 dose of study medication
    Statistical analysis title
    		 Statistical Analysis #1
    Comparison groups
    FF/VI 100/25 µg v FF 100 µg
    Number of subjects included in analysis
    2019
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    Parameter type
    		 Regression Cox
    Point estimate
    0.795
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.642
         upper limit
    		 0.985
    Notes
    [3] - The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.
    Statistical analysis title
    		 Statistical Analysis #2
    Statistical analysis description
    The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.
    Comparison groups
    FF/VI 100/25 µg v FF 100 µg
    Number of subjects included in analysis
    2019
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036 [4]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.5
         upper limit
    		 18.2
    Notes
    [4] - P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.
    Statistical analysis title
    		 Statistical Analysis #3
    Statistical analysis description
    The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.
    Comparison groups
    FF/VI 100/25 µg v FF 100 µg
    Number of subjects included in analysis
    2019
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036 [5]
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 14.9
    Notes
    [5] - P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.

    Secondary: Number of severe asthma exacerbations

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    End point title
    		 Number of severe asthma exacerbations
    End point description
    A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.
    End point type
    Secondary
    End point timeframe
    Baseline to Follow-up (up to 76 weeks of treatment)
    End point values
    		 FF 100 µg FF/VI 100/25 µg
    Number of subjects analysed
    1010 [6]
    1009 [7]
    Units: Severe asthma exacerbations
    271
    200
    Notes
    [6] - ITT Population
    [7] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in evening pre-dose trough FEV1 at Week 36

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    End point title
    		 Change from Baseline in evening pre-dose trough FEV1 at Week 36
    End point description
    Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 36
    End point values
    		 FF 100 µg FF/VI 100/25 µg
    Number of subjects analysed
    902 [8]
    926 [9]
    Units: Liters
        least squares mean (standard error)
    0.265 ± 0.014
    0.348 ± 0.014
    Notes
    [8] - ITT Population. Only participants available at the indicated time point (Week 36) were analyzed.
    [9] - ITT Population. Only participants available at the indicated time point (Week 36) were analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to End of Study
    Adverse event reporting additional description
    Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    FF 100 µg
    Reporting group description
    		 Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

    Reporting group title
    FF/VI 100/25 µg
    Reporting group description
    		 Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

    Serious adverse events
    		 FF 100 µg FF/VI 100/25 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 1010 (2.87%)
    41 / 1009 (4.06%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondroma
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer stage I
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 1010 (0.10%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Diabetic microangiopathy
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 1010 (0.10%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal polyps
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    9 / 1010 (0.89%)
    11 / 1009 (1.09%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fear
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         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
    Hand fracture
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (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
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Upper limb fracture
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 1010 (0.10%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         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
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (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 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 1010 (0.00%)
    1 / 1009 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 1010 (0.40%)
    4 / 1009 (0.40%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Diabetic foot
         subjects affected / exposed
    1 / 1010 (0.10%)
    0 / 1009 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 FF 100 µg FF/VI 100/25 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    479 / 1010 (47.43%)
    467 / 1009 (46.28%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    179 / 1010 (17.72%)
    188 / 1009 (18.63%)
         occurrences all number
    599
    615
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    23 / 1010 (2.28%)
    36 / 1009 (3.57%)
         occurrences all number
    29
    48
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    26 / 1010 (2.57%)
    33 / 1009 (3.27%)
         occurrences all number
    41
    97
    Rhinitis allergic
         subjects affected / exposed
    26 / 1010 (2.57%)
    39 / 1009 (3.87%)
         occurrences all number
    31
    58
    Oropharyngeal pain
         subjects affected / exposed
    55 / 1010 (5.45%)
    41 / 1009 (4.06%)
         occurrences all number
    63
    57
    Cough
         subjects affected / exposed
    64 / 1010 (6.34%)
    55 / 1009 (5.45%)
         occurrences all number
    95
    89
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    40 / 1010 (3.96%)
    41 / 1009 (4.06%)
         occurrences all number
    58
    52
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    41 / 1010 (4.06%)
    29 / 1009 (2.87%)
         occurrences all number
    45
    32
    Sinusitis
         subjects affected / exposed
    38 / 1010 (3.76%)
    42 / 1009 (4.16%)
         occurrences all number
    55
    67
    Influenza
         subjects affected / exposed
    38 / 1010 (3.76%)
    50 / 1009 (4.96%)
         occurrences all number
    48
    60
    Bronchitis
         subjects affected / exposed
    74 / 1010 (7.33%)
    59 / 1009 (5.85%)
         occurrences all number
    85
    75
    Upper respiratory tract infection
         subjects affected / exposed
    93 / 1010 (9.21%)
    73 / 1009 (7.23%)
         occurrences all number
    129
    114
    Nasopharyngitis
         subjects affected / exposed
    131 / 1010 (12.97%)
    155 / 1009 (15.36%)
         occurrences all number
    194
    247

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2009
    Japanese country-specific amendment to: change age of eligible participants to 18 years of age and older; addition of open-label fluticasone propionate 250 µg for use by appropriate participants during the 2-week Run-in Period; addition of clinical laboratory testing at Weeks 12, 28, and 52 and last on-treatment visit.

    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
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