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    Clinical Trial Results:
    A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

    Summary
    EudraCT number
    		 2015-003533-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Apr 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025ABR01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00567476
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 613241111,
    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
    28 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)
    Protection of trial subjects
    Subjects were advised that between visits they could take rescue medication using inhaled salbutamol or terbuline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hours had to be recorded in the subject diary. If reversibility was going to be assessed, subjects could NOT use their rescue medication within 6 hours of the spirometry, unless severe intercurrent bronchospasm was developed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 2007
    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
    Brazil: 116
    Worldwide total number of subjects
    116
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    105
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects randomized to this study had to meet the GINA guidelines criteria for severe persistent asthma. Current international asthma management guidelines (GINA – Global Initiative for Asthma) advocate the importance of combined pharmacotherapy to control the underlying inflammatory disease and relieve acute symptoms.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Xolair®+ Conventional Therapy
    Arm description
    		 Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Xolair®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.

    Investigational medicinal product name
    Inhaled corticosteroids (ICS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent.

    Investigational medicinal product name
    Long-acting beta 2-adrenergic agonist (LABA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fixed dose of LABA as prescribed prior to study entry

    Investigational medicinal product name
    Short-acting beta 2-adrenergic agonist (SABA)
    Investigational medicinal product code
    Other name
    salbutamol, terbutaline
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

    Arm title
    		 Conventional Therapy
    Arm description
    		 Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Inhaled corticosteroids (ICS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent.

    Investigational medicinal product name
    Long-acting beta 2-adrenergic agonist (LABA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fixed dose of LABA as prescribed prior to study entry

    Investigational medicinal product name
    Short-acting beta 2-adrenergic agonist (SABA)
    Investigational medicinal product code
    Other name
    salbutamol, terbutaline
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

    Number of subjects in period 1
    		Xolair®+ Conventional Therapy Conventional Therapy
    Started
    78
    38
    Completed
    70
    34
    Not completed
    8
    4
         Administrative issues
    1
    -
         Adverse event, non-fatal
    2
    -
         Significant protocol violation
    4
    1
         Withdrew because of medical decision
    -
    1
         Pregnancy
    1
    -
         Lost to follow-up
    -
    1
         No adherence to the protocol
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Xolair®+ Conventional Therapy
    Reporting group description
    		 Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.

    Reporting group title
    Conventional Therapy
    Reporting group description
    		 Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.

    Reporting group values
    		 Xolair®+ Conventional Therapy Conventional Therapy Total
    Number of subjects
    		 78 38 116
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 1 1 2
        Adults (18-64 years)
    		 72 33 105
        From 65-84 years
    		 5 4 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.8 ( 13.1 ) 45.2 ( 12.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 60 29 89
        Male
    		 18 9 27

    End points

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    End points reporting groups
    Reporting group title
    Xolair®+ Conventional Therapy
    Reporting group description
    		 Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.

    Reporting group title
    Conventional Therapy
    Reporting group description
    		 Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.

    Primary: The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)

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    End point title
    		 The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ) [1]
    End point description
    The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.
    End point type
    Primary
    End point timeframe
    Baseline and Week 20
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis provided for this primary end point.
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    78 [2]
    38
    Units: Units on a scale
    arithmetic mean (standard error)
        Baseline (n=77, 37)
    3.1 ( 1 )
    3.1 ( 1.1 )
        At Week 20 (n=78, 36)
    4.4 ( 1.4 )
    3 ( 1.1 )
        Change from baseline to week 20 (n=77, 36)
    1.2 ( 0.1 )
    -0.1 ( 0.1 )
    Notes
    [2] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks

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    End point title
    		 Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks
    End point description
    The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    77 [3]
    36
    Units: Percentage of participants
        number (confidence interval 95%)
    40.3 (30 to 51.4)
    2.8 (0.5 to 14.2)
    Notes
    [3] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacyassesment
    No statistical analyses for this end point

    Secondary: Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20

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    End point title
    		 Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20
    End point description
    The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    77 [4]
    36
    Units: Percentage of participants
        number (confidence interval 95%)
    70.1 (59.2 to 79.2)
    22.2 (11.7 to 38.1)
    Notes
    [4] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: The Mean Change From Baseline to the End of Study in AQLQ Domain Score

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    End point title
    		 The Mean Change From Baseline to the End of Study in AQLQ Domain Score
    End point description
    AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration. The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    78 [5]
    38
    Units: Units on a scale
    arithmetic mean (standard error)
        Activity limitation score
    1.3 ( 0.1 )
    -0.2 ( 0.1 )
        Symptoms score
    1.2 ( 0.2 )
    -0.2 ( 0.2 )
        Emotional function score
    1.3 ( 0.2 )
    0 ( 0.1 )
        Environmental stimuli score
    1.2 ( 0.2 )
    0 ( 0.2 )
    Notes
    [5] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: Number of Asthma Exacerbation Episodes Per Participant

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    End point title
    		 Number of Asthma Exacerbation Episodes Per Participant
    End point description
    For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.
    End point type
    Secondary
    End point timeframe
    From Baseline through 20 weeks
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    78 [6]
    38
    Units: Participants
    number (not applicable)
        Patients with 1 episode
    25
    12
        Patients with 2 episodes
    5
    6
        Patients with 3 episodes
    3
    1
        Patients with 4 episodes
    1
    1
        Total number of patients with episodes
    34
    20
    Notes
    [6] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: Percentage of Participants Using Rescue Medication

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    End point title
    		 Percentage of Participants Using Rescue Medication
    End point description
    When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.
    End point type
    Secondary
    End point timeframe
    From Baseline through 20 Weeks
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    78 [7]
    38
    Units: Percentage of participants
        number (confidence interval 95%)
    43.6 (33.1 to 54.6)
    44.7 (30.1 to 60.3)
    Notes
    [7] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: Mean Number of Puffs of Rescue Medication Taken Per Day

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    End point title
    		 Mean Number of Puffs of Rescue Medication Taken Per Day
    End point description
    When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.
    End point type
    Secondary
    End point timeframe
    From Baseline through 20 Weeks
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    34 [8]
    17
    Units: Puffs
        arithmetic mean (standard deviation)
    5.5 ( 4.1 )
    6.4 ( 4.7 )
    Notes
    [8] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment of Treatment Effectiveness

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    End point title
    		 Physician's Global Assessment of Treatment Effectiveness
    End point description
    At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma
    End point type
    Secondary
    End point timeframe
    20 Weeks
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    76 [9]
    37
    Units: Participants
    number (not applicable)
        Excellent
    22
    2
        Good
    35
    4
        Moderate
    13
    11
        Poor
    6
    18
        Worsening
    0
    2
    Notes
    [9] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Secondary: Patient's Global Assessment of Treatment Effectiveness

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    End point title
    		 Patient's Global Assessment of Treatment Effectiveness
    End point description
    At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma.
    End point type
    Secondary
    End point timeframe
    20 Weeks
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    76 [10]
    37
    Units: Participants
    number (not applicable)
        Excellent
    33
    3
        Good
    30
    13
        Moderate
    10
    10
        Poor
    3
    9
        Worsening
    0
    2
    Notes
    [10] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Other pre-specified: Free Days With no Rescue Medication

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    End point title
    		 Free Days With no Rescue Medication
    End point description
    When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.
    End point type
    Other pre-specified
    End point timeframe
    From Baseline through 20 weeks (140 days)
    End point values
    		 Xolair®+ Conventional Therapy Conventional Therapy
    Number of subjects analysed
    78 [11]
    38
    Units: Days
        arithmetic mean (standard deviation)
    73.5 ( 39.4 )
    74.9 ( 35.4 )
    Notes
    [11] - intent-to treat (ITT) population- 1 dose of study drug and 1 post-baseline safety/efficacy assesment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    XOLAIR® +LABA + ICS
    Reporting group description
    		 XOLAIR® +LABA + ICS

    Reporting group title
    LABA + ICS
    Reporting group description
    		 LABA + ICS

    Serious adverse events
    		 XOLAIR® +LABA + ICS LABA + ICS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 78 (3.85%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 38 (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
    Pneumonia
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 38 (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: 5%
    Non-serious adverse events
    		 XOLAIR® +LABA + ICS LABA + ICS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 78 (53.85%)
    16 / 38 (42.11%)
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    4 / 78 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 78 (20.51%)
    4 / 38 (10.53%)
         occurrences all number
    39
    9
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 78 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 78 (1.28%)
    2 / 38 (5.26%)
         occurrences all number
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    6 / 78 (7.69%)
    0 / 38 (0.00%)
         occurrences all number
    6
    0
    Respiratory tract infection
         subjects affected / exposed
    8 / 78 (10.26%)
    3 / 38 (7.89%)
         occurrences all number
    9
    3
    Rhinitis
         subjects affected / exposed
    3 / 78 (3.85%)
    4 / 38 (10.53%)
         occurrences all number
    8
    4
    Rhinitis allergic
         subjects affected / exposed
    1 / 78 (1.28%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Sinusitis
         subjects affected / exposed
    10 / 78 (12.82%)
    2 / 38 (5.26%)
         occurrences all number
    11
    2
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 38 (7.89%)
         occurrences all number
    5
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 78 (6.41%)
    2 / 38 (5.26%)
         occurrences all number
    7
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 78 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    4
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 78 (10.26%)
    1 / 38 (2.63%)
         occurrences all number
    9
    1

    More information

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

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

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

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