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    Clinical Trial Results:
    FFA115285: A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids.

    Summary
    EudraCT number
    2011-001900-36
    Trial protocol
    NL   PL  
    Global end of trial date
    26 Sep 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    FFA115285
    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 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, +1 8664357343,
    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
    29 Oct 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of inhaled fluticasone furoate 50 mcg administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 24-week treatment period.
    Protection of trial subjects
    Participant withdrawal due to lack of efficacy was required when: A participant’s clinic FEV1 fell below the FEV1 stability limit value calculated at Visit 2; In the 7 days immediately preceding any contact, the subject experienced: at least 4 days in which the AM or PM PEF fell below the PEF stability limit calculated at Visit 2 and/or at least 3 days in which >=12 inhalations/day of albuterol/salbutamol were used; A participant experienced a protocol-defined severe asthma exacerbation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Sep 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
    United States: 232
    Country: Number of subjects enrolled
    Mexico: 96
    Country: Number of subjects enrolled
    Netherlands: 38
    Country: Number of subjects enrolled
    Peru: 150
    Country: Number of subjects enrolled
    Poland: 86
    Country: Number of subjects enrolled
    Russian Federation: 53
    Worldwide total number of subjects
    655
    EEA total number of subjects
    124
    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)
    96
    Adults (18-64 years)
    525
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants (par.) meeting eligibility criteria at the Screening visit entered a 2-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 24-week Treatment Period. A total of 655 participants were screened; 351 were randomized, and 347 received >=1 dose of study treatment.

    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
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks.

    Arm title
    FF 50 µg OD
    Arm description
    Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
    Arm type
    Experimental

    Investigational medicinal product name
    FF 50 µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks.

    Arm title
    FP 100 µg BID
    Arm description
    Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
    Arm type
    Active comparator

    Investigational medicinal product name
    FP 100 µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks.

    Number of subjects in period 1 [1]
    Placebo FF 50 µg OD FP 100 µg BID
    Started
    115
    117
    115
    Completed
    77
    91
    95
    Not completed
    38
    26
    20
         Protocol deviation
    3
    1
    1
         Physician decision
    3
    1
    1
         Lack of efficacy
    23
    14
    9
         Adverse event, non-fatal
    2
    1
    2
         Consent withdrawn by subject
    6
    8
    4
         Lost to follow-up
    1
    1
    3
    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 655 participants were screened; 351 were randomized, and 347 received >=1 dose of study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group title
    FF 50 µg OD
    Reporting group description
    Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group title
    FP 100 µg BID
    Reporting group description
    Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group values
    Placebo FF 50 µg OD FP 100 µg BID Total
    Number of subjects
    115 117 115 347
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.6 ± 18.03 35.4 ± 14.64 36.2 ± 16.95 -
    Gender categorical
    Units: Subjects
        Female
    81 72 76 229
        Male
    34 45 39 118
    Race, Customized
    Units: Subjects
        White - White/Caucasian/European Heritage
    52 55 54 161
        American Indian or Alaska Native
    31 30 34 95
        Mixed Race
    22 17 18 57
        African American/African Heritage
    9 14 9 32
        Asian - East Asian Heritage
    1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group title
    FF 50 µg OD
    Reporting group description
    Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group title
    FP 100 µg BID
    Reporting group description
    Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Primary: Change from Baseline in clinic visit evening (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at the end of the 24-week treatment period

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    End point title
    Change from Baseline in clinic visit evening (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at the end of the 24-week treatment period
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo FF 50 µg OD FP 100 µg BID
    Number of subjects analysed
    111 [1]
    116 [2]
    112 [3]
    Units: Liters
        least squares mean (standard error)
    0.089 ± 0.0331
    0.126 ± 0.0323
    0.191 ± 0.0328
    Notes
    [1] - Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose.
    [2] - Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose.
    [3] - Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose.
    Statistical analysis title
    Analysis 1
    Comparison groups
    Placebo v FF 50 µg OD
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.43
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.037
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.055
         upper limit
    0.128
    Statistical analysis title
    Analysis 2
    Comparison groups
    Placebo v FP 100 µg BID
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.03
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.194

    Secondary: Change from Baseline in the percentage of rescue-free 24-hour (hr) periods over the 24-week treatment period

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    End point title
    Change from Baseline in the percentage of rescue-free 24-hour (hr) periods over the 24-week treatment period
    End point description
    The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). 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 to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 24
    End point values
    Placebo FF 50 µg OD FP 100 µg BID
    Number of subjects analysed
    114 [4]
    116 [5]
    113 [6]
    Units: Percentage of rescue-free 24-hr periods
        least squares mean (standard error)
    21.1 ± 3.2
    28.9 ± 3.17
    31.7 ± 3.21
    Notes
    [4] - ITT Population. Only those participants available at the specified time points were analyzed.
    [5] - ITT Population. Only those participants available at the specified time points were analyzed.
    [6] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in daily evening (PM) peak expiratory flow (PEF) averaged over the 24-week treatment period

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    End point title
    Change from Baseline in daily evening (PM) peak expiratory flow (PEF) averaged over the 24-week treatment period
    End point description
    PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 24
    End point values
    Placebo FF 50 µg OD FP 100 µg BID
    Number of subjects analysed
    114 [7]
    116 [8]
    113 [9]
    Units: Liters/minute (L/min)
        least squares mean (standard error)
    7.6 ± 4.08
    24.9 ± 4.04
    12 ± 4.09
    Notes
    [7] - ITT Population. Only those participants available at the specified time points were analyzed.
    [8] - ITT Population. Only those participants available at the specified time points were analyzed.
    [9] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in daily morning (AM) PEF averaged over the 24-week treatment period

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    End point title
    Change from Baseline in daily morning (AM) PEF averaged over the 24-week treatment period
    End point description
    PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 24
    End point values
    Placebo FF 50 µg OD FP 100 µg BID
    Number of subjects analysed
    114 [10]
    116 [11]
    113 [12]
    Units: L/min
        least squares mean (standard error)
    10.8 ± 3.85
    30 ± 3.81
    21.4 ± 3.86
    Notes
    [10] - ITT Population. Only those participants available at the specified time points were analyzed.
    [11] - ITT Population. Only those participants available at the specified time points were analyzed.
    [12] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the percentage of symptom-free 24-hour (hr) periods during the 24-week treatment period

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    End point title
    Change from Baseline in the percentage of symptom-free 24-hour (hr) periods during the 24-week treatment period
    End point description
    Asthma symptoms were recorded in a daily eDiary by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 24
    End point values
    Placebo FF 50 µg OD FP 100 µg BID
    Number of subjects analysed
    114 [13]
    116 [14]
    113 [15]
    Units: Percentage of symptom-free 24-hr periods
        least squares mean (standard error)
    16.8 ± 2.88
    25.1 ± 2.85
    24.3 ± 2.88
    Notes
    [13] - ITT Population. Only those participants available at the specified time points were analyzed.
    [14] - ITT Population. Only those participants available at the specified time points were analyzed.
    [15] - ITT Population. Only those participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants who withdrew due to lack of efficacy during the 24-week treatment period

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    End point title
    Number of participants who withdrew due to lack of efficacy during the 24-week treatment period
    End point description
    The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.
    End point type
    Secondary
    End point timeframe
    From the first dose of the study medication until Week 24/Early Withdrawal
    End point values
    Placebo FF 50 µg OD FP 100 µg BID
    Number of subjects analysed
    115 [16]
    117 [17]
    115 [18]
    Units: participants
    23
    14
    9
    Notes
    [16] - ITT Population
    [17] - ITT Population
    [18] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
    Adverse event reporting additional description
    Serious AEs (SAEs) and non-serious AEs were collected in the ITT, 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
    15.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group title
    FF 50 µg OD
    Reporting group description
    Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Reporting group title
    FP 100 µg BID
    Reporting group description
    Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.

    Serious adverse events
    Placebo FF 50 µg OD FP 100 µg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Reproductive system and breast disorders
    Premenstrual syndrome
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 117 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 117 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 117 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Placebo FF 50 µg OD FP 100 µg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 115 (31.30%)
    38 / 117 (32.48%)
    39 / 115 (33.91%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    6 / 115 (5.22%)
    0 / 117 (0.00%)
    2 / 115 (1.74%)
         occurrences all number
    6
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 115 (11.30%)
    17 / 117 (14.53%)
    12 / 115 (10.43%)
         occurrences all number
    17
    25
    19
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    4 / 115 (3.48%)
    2 / 117 (1.71%)
    1 / 115 (0.87%)
         occurrences all number
    4
    2
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 115 (3.48%)
    4 / 117 (3.42%)
    6 / 115 (5.22%)
         occurrences all number
    4
    4
    7
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 115 (2.61%)
    6 / 117 (5.13%)
    6 / 115 (5.22%)
         occurrences all number
    3
    7
    6
    Pharyngitis
         subjects affected / exposed
    10 / 115 (8.70%)
    7 / 117 (5.98%)
    5 / 115 (4.35%)
         occurrences all number
    12
    8
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 115 (5.22%)
    8 / 117 (6.84%)
    12 / 115 (10.43%)
         occurrences all number
    6
    10
    13

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2011
    The number of withdrawals due to lack of efficacy was changed from an ‘other’ endpoint to a secondary endpoint.

    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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