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    Clinical Trial Results:
    MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma

    Summary
    EudraCT number
    		 2012-001497-29
    Trial protocol
    		 GB   DE   NL   CZ  
    Global end of trial date
    12 Dec 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MEA115575
    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-000069-PIP02-10
    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
    11 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS) in systemic corticosteroid dependent subjects with severe refractory asthma with elevated eosinophils.
    Protection of trial subjects
    Numbing cream or spray was permitted at the site of injection and rescue medications (salbuterol/albuterol) are available to the participant throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 25
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Czech Republic: 13
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    135
    EEA total number of subjects
    98
    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)
    2
    Adults (18-64 years)
    119
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study consisted 4 phases: oral corticosteroids (OCS) Optimization (Run-in); Induction; OCS Reduction and Maintenance. Participants (par.) who completed the 4 phases and met the eligibility criteria were offered the opportunity to participate in an open label extension (OLE) study. Par. not entering the OLE study completed the Follow-up Visit.

    Pre-assignment
    Screening details
    		 A total of 185 Par were enrolled; 3 Par were Screen failures; 47 Par were Run-in failures; 135 Par were randomized and received >=1 dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (normal saline)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Every 4 weeks

    Arm title
    		 Mepolizumab
    Arm description
    		 Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg every 4 weeks

    Number of subjects in period 1
    		Placebo Mepolizumab
    Started
    66
    69
    Completed
    62
    66
    Not completed
    4
    3
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.

    Reporting group title
    Mepolizumab
    Reporting group description
    		 Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.

    Reporting group values
    		 Placebo Mepolizumab Total
    Number of subjects
    		 66 69 135
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.9 ( 10.3 ) 49.8 ( 14.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 44 74
        Male
    		 36 25 61
    Race
    Units: Subjects
        American Indian or Alaskan Native
    		 1 0 1
        Asian - Central/South Asian Heritage
    		 1 0 1
        Asian - East Asian Heritage
    		 0 1 1
        Asian - South East Asian Heritage
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        White - Arabic/North African Heritage
    		 1 2 3
        White - White/Caucasian/European Heritage
    		 60 65 125
        Mixed Race
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.

    Reporting group title
    Mepolizumab
    Reporting group description
    		 Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.

    Primary: Number of participants with the indicated percent reduction from Baseline in oral corticosteroid (OCS) dose during Weeks 20 to 24 while maintaining asthma control

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    End point title
    		 Number of participants with the indicated percent reduction from Baseline in oral corticosteroid (OCS) dose during Weeks 20 to 24 while maintaining asthma control
    End point description
    Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.
    End point type
    Primary
    End point timeframe
    Baseline; Weeks 20 to 24
    End point values
    		 Placebo Mepolizumab
    Number of subjects analysed
    66 [1]
    69 [2]
    Units: Participants
        90 to 100%
    7
    16
        75 to <90%
    5
    12
        50 to <75%
    10
    9
        >0 to <50%
    7
    7
        No decrease /lack of asthma control/early WD
    37
    25
    Notes
    [1] - Intent-to-Treat (ITT) Population: all randomized par. who received at >= 1 dose of study medication.
    [2] - Intent-to-Treat (ITT) Population: all randomized par. who received at >= 1 dose of study medication.
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Placebo v Mepolizumab
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 4.56

    Secondary: Number of participants who achieved a reduction of >=50% in their daily oral corticosteroid (OCS) dose compared with Baseline dose, during weeks 20 to 24 while maintaining asthma control

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    End point title
    		 Number of participants who achieved a reduction of >=50% in their daily oral corticosteroid (OCS) dose compared with Baseline dose, during weeks 20 to 24 while maintaining asthma control
    End point description
    Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 20 to 24
    End point values
    		 Placebo Mepolizumab
    Number of subjects analysed
    66 [3]
    69 [4]
    Units: Participants
        50 to 100%
    22
    37
        <50% or no decrease/lack of asthma control/WD
    44
    32
    Notes
    [3] - ITT Population
    [4] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg during weeks 20 to 24 while maintaining asthma control

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    End point title
    		 Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg during weeks 20 to 24 while maintaining asthma control
    End point description
    Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.
    End point type
    Secondary
    End point timeframe
    Weeks 20 to 24
    End point values
    		 Placebo Mepolizumab
    Number of subjects analysed
    66 [5]
    69 [6]
    Units: Participants
        <=5 mg/day
    21
    37
        >5 mg/day or lack of asthma control or WD
    45
    32
    Notes
    [5] - ITT Population
    [6] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants who achieved a total reduction of OCS dose during weeks 20 to 24 while maintaining asthma control

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    End point title
    		 Number of participants who achieved a total reduction of OCS dose during weeks 20 to 24 while maintaining asthma control
    End point description
    MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.
    End point type
    Secondary
    End point timeframe
    Weeks 20 to 24
    End point values
    		 Placebo Mepolizumab
    Number of subjects analysed
    66 [7]
    69 [8]
    Units: Participants
        0 mg/day
    5
    10
        OCS taken or lack of asthma control or WD
    61
    59
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Median percentage reduction from Baseline in daily OCS dose during weeks 20 to 24 while maintaining asthma control

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    End point title
    		 Median percentage reduction from Baseline in daily OCS dose during weeks 20 to 24 while maintaining asthma control
    End point description
    BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 20 to 24
    End point values
    		 Placebo Mepolizumab
    Number of subjects analysed
    66 [9]
    69 [10]
    Units: Percentage reduction in OCS dose
        median (confidence interval 95%)
    0 (-20 to 33.3)
    50 (20 to 75)
    Notes
    [9] - ITT Population
    [10] - 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 serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 28 days after the last dose of investigational product.
    Adverse event reporting additional description
    SAEs and Non-serious AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants who were randomized and who received at least one dose of study medication. The number of occurrences for non-serious AEs was not collected; therefore, 0 has been entered.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medication salbutamol/albuterol) /equipment were available throughout the study.

    Reporting group title
    Mepolizumab
    Reporting group description
    		 Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.

    Serious adverse events
    		 Placebo Mepolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 66 (18.18%)
    1 / 69 (1.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post gastric surgery syndrome
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (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
    Prostatitis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (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
    Asthma
         subjects affected / exposed
    7 / 66 (10.61%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fistula
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 69 (1.45%)
         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
    3 / 66 (4.55%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (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
    Hypokalaemia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 69 (1.45%)
         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: 3%
    Non-serious adverse events
    		 Placebo Mepolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 66 (80.30%)
    47 / 69 (68.12%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 66 (6.06%)
    7 / 69 (10.14%)
         occurrences all number
    0
    0
    Pyrexia
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    Injection site reaction
         subjects affected / exposed
    2 / 66 (3.03%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 66 (3.03%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 66 (7.58%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 66 (1.52%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    Injury, poisoning and procedural complications
    Injection related reaction
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 66 (21.21%)
    14 / 69 (20.29%)
         occurrences all number
    0
    0
    Dizziness
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    Sinus headache
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 66 (9.09%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    Toothache
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    Urticaria
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    Rash
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 66 (6.06%)
    5 / 69 (7.25%)
         occurrences all number
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 66 (1.52%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    Back pain
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 66 (0.00%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 66 (15.15%)
    10 / 69 (14.49%)
         occurrences all number
    0
    0
    Bronchitis
         subjects affected / exposed
    6 / 66 (9.09%)
    7 / 69 (10.14%)
         occurrences all number
    0
    0
    Sinusitis
         subjects affected / exposed
    6 / 66 (9.09%)
    7 / 69 (10.14%)
         occurrences all number
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 66 (7.58%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 66 (1.52%)
    5 / 69 (7.25%)
         occurrences all number
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 66 (3.03%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    Influenza
         subjects affected / exposed
    1 / 66 (1.52%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    Cystitis
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    Otitis media
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    Tooth infection
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Aug 2012
    - Clarified inclusion criteria 6 - Modified randomisation criteria 4 - Clarified primary endpoint - Reduced number of secondary endpoints

    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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