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    Clinical Trial Results:
    Multicentric, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12-MonthPeriod, in Patients with Severe IgE-mediated Asthma Inadequately Controlled with High Doses of Corticosteroids. MEXIC Study

    Summary
    EudraCT number
    		 2016-004315-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2018
    First version publication date
    16 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025AMX02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01912872
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Novartis Pharmaceuticals AG Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Novartis Pharmaceuticals AG Clinical Disclosure Office, Novartis Pharma 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
    08 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult patients with severe IgE-mediated asthma inadequately controlled with high doses of corticosteroids.)
    Protection of trial subjects
    The use of rescue medication (salbutamol and steroids) was allowed throughout the study in the event of asthma exacerbation defined as a sudden progressive increase in shortness of breath, cough, wheezing or chest tightness or a combination of these signs and symptoms. Under this situation, the patient was instructed to take rescue medication, but if the asthma exacerbation was not controlled, the patient was instructed to notify the Investigator and attend its office, where the Investigator decided whether to treat the patient at the office or send to the emergency service.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2013
    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
    Mexico: 112
    Worldwide total number of subjects
    112
    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)
    16
    Adolescents (12-17 years)
    17
    Adults (18-64 years)
    79
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study population consisted of male and female patients aged between 6 to 55 years with moderate to severe uncontrolled IgE-mediated asthma recruited from outpatient private clinics in Mexico.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol
    Arm description
    		 Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection dose according to the IgE level and body weight.

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Investigational medicinal product name
    Formoterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Arm title
    		 Pediatric Patients: Budesonide and Formoterol
    Arm description
    		 Participants received budesonide + formoterol administered through an inhaler device.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Formoterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Arm title
    		 Adult Patients: Omalizumab + Budesonide and Formoterol
    Arm description
    		 Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection dose according to the IgE level and body weight.

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Investigational medicinal product name
    Formoterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Arm title
    		 Adult Patients: Budesonide and Formoterol
    Arm description
    		 Participants receive budesonide + formoterol administered through an inhaler device.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Investigational medicinal product name
    Formoterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures’ prescription information.

    Number of subjects in period 1
    		Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Started
    16
    17
    40
    39
    Completed
    11
    13
    30
    27
    Not completed
    5
    4
    10
    12
         Consent withdrawn by subject
    -
    -
    1
    1
         Other unspecified
    3
    1
    3
    -
         Unsatisfactory therapeutic effect
    -
    -
    -
    2
         Protocol Violation
    -
    -
    1
    -
         Lost to follow-up
    2
    3
    5
    5
         Non-compliance with lab inc/exclusion
    -
    -
    -
    1
         Missing
    -
    -
    -
    1
         Withdrawal of study medication
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pediatric Patients: Omalizumab + Budesonide and Formoterol
    Reporting group description
    		 Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Pediatric Patients: Budesonide and Formoterol
    Reporting group description
    		 Participants received budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Adult Patients: Omalizumab + Budesonide and Formoterol
    Reporting group description
    		 Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Adult Patients: Budesonide and Formoterol
    Reporting group description
    		 Participants receive budesonide + formoterol administered through an inhaler device.

    Reporting group values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol Total
    Number of subjects
    		 16 17 40 39 112
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 11 5 0 0 16
        Adolescents (12-17 years)
    		 5 12 0 0 17
        Adults (18-64 years)
    		 0 0 40 39 79
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.1 ± 3.32 12.4 ± 1.80 37.6 ± 10.01 38.7 ± 10.30 -
    Gender categorical
    Units: Subjects
        Female
    		 6 8 28 28 70
        Male
    		 10 9 12 11 42

    End points

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    End points reporting groups
    Reporting group title
    Pediatric Patients: Omalizumab + Budesonide and Formoterol
    Reporting group description
    		 Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Pediatric Patients: Budesonide and Formoterol
    Reporting group description
    		 Participants received budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Adult Patients: Omalizumab + Budesonide and Formoterol
    Reporting group description
    		 Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Adult Patients: Budesonide and Formoterol
    Reporting group description
    		 Participants receive budesonide + formoterol administered through an inhaler device.

    Primary: Prescribed Budesonide Dose (μg) at Baseline

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    End point title
    		 Prescribed Budesonide Dose (μg) at Baseline [1]
    End point description
    Data for primary efficacy variable was captured by recording at each visit the actual weekly or every 2 weeks dose of omalizumab and daily dose of budesonide/formoterol each participant received since the last visit. Baseline summaries presented only due to early termination of the trial. Pediatric and Adult intent-to-treat (ITT) and per protocol (PP) populations. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables. PP population was participants that completed 12 months of treatment, had a valid assessment of the primary efficacy variable at Week 24.
    End point type
    Primary
    End point timeframe
    Baseline
    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 analyses have been performed/reported for this primary end point.
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    16 [2]
    17 [3]
    40 [4]
    39 [5]
    Units: μg
    arithmetic mean (standard deviation)
        ITT
    337.5 ± 95.74
    270.6 ± 98.52
    580.0 ± 201.53
    533.3 ± 248.50
        PP
    363.6 ± 80.90
    250.0 ± 90.45
    575.0 ± 201.61
    533.3 ± 258.20
    Notes
    [2] - Pediatric intent-to-treat (ITT) and per protocol (PP) populations. N = 16, 11
    [3] - Pediatric intent-to-treat (ITT) and per protocol (PP) populations. N = 17, 12
    [4] - Adult intent-to-treat (ITT) and per protocol (PP) populations. N= 40, 32
    [5] - Adult intent-to-treat (ITT) and per protocol (PP) populations. N= 39, 33
    No statistical analyses for this end point

    Secondary: Number of Hospital Admissions Due to Asthma Exacerbation

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    End point title
    		 Number of Hospital Admissions Due to Asthma Exacerbation
    End point description
    A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.
    End point type
    Secondary
    End point timeframe
    12 month treatment duration
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    16 [6]
    17 [7]
    40 [8]
    39 [9]
    Units: hospital admissions
        number (not applicable)
    0
    1
    0
    0
    Notes
    [6] - ITT population
    [7] - ITT population
    [8] - ITT population
    [9] - ITT population
    No statistical analyses for this end point

    Secondary: Days Missed in School/Work Due to Asthma Exacerbation Episodes

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    End point title
    		 Days Missed in School/Work Due to Asthma Exacerbation Episodes
    End point description
    Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.
    End point type
    Secondary
    End point timeframe
    12 month treatment duration
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    16 [10]
    17 [11]
    40 [12]
    39 [13]
    Units: days
    number (not applicable)
        Missed school days
    2
    3
    1
    0
        Missed work days
    0
    1
    0
    1
    Notes
    [10] - ITT population
    [11] - ITT population
    [12] - ITT population
    [13] - ITT population
    No statistical analyses for this end point

    Secondary: Control of Asthma Symptoms- Daytime Symptoms

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    End point title
    		 Control of Asthma Symptoms- Daytime Symptoms
    End point description
    The clinical control of asthma was defined according to the following criteria (GINA 2012): Daytime symptoms: none or less than twice a week Limitations of daily activities: none Nocturnal symptoms or awakening because of asthma: none Need of relief or rescue medication: none or less than twice a week Lung function (PEF or FEV1) without administration of bronchodilator: normal
    End point type
    Secondary
    End point timeframe
    12 month treatment duration
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    16 [14]
    17 [15]
    40 [16]
    39 [17]
    Units: percentage of participants
        number (not applicable)
    62.5
    70.6
    82.5
    71.8
    Notes
    [14] - ITT population
    [15] - ITT population
    [16] - ITT population
    [17] - ITT population
    No statistical analyses for this end point

    Secondary: Control of Asthma Symptoms

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    End point title
    		 Control of Asthma Symptoms
    End point description
    The clinical control of asthma was defined according to the following criteria (GINA 2012): Daytime symptoms: none or less than twice a week Limitations of daily activities: none Nocturnal symptoms or awakening because of asthma: none Need of relief or rescue medication: none or less than twice a week Lung function (PEF or FEV1) without administration of bronchodilator: normal
    End point type
    Secondary
    End point timeframe
    12 month treatment duration
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    16 [18]
    17 [19]
    40 [20]
    39 [21]
    Units: Number of days
    arithmetic mean (standard deviation)
        Wheezing
    15.4 ± 23.43
    21.1 ± 32.84
    25.4 ± 28.89
    29.0 ± 36.30
        Night time cough
    12.8 ± 7.75
    20.8 ± 27.24
    20.6 ± 22.09
    32.3 ± 42.50
    Notes
    [18] - ITT population N= 11, 13
    [19] - ITT population N= 15, 17
    [20] - ITT population N= 32, 33
    [21] - ITT population N= 35, 33
    No statistical analyses for this end point

    Secondary: Control of Asthma Symptoms- Rescue Medication Use

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    End point title
    		 Control of Asthma Symptoms- Rescue Medication Use
    End point description
    The clinical control of asthma was defined according to the following criteria (GINA 2012): Daytime symptoms: none or less than twice a week Limitations of daily activities: none Nocturnal symptoms or awakening because of asthma: none Need of relief or rescue medication: none or less than twice a week Lung function (PEF or FEV1) without administration of bronchodilator: normal
    End point type
    Secondary
    End point timeframe
    12 month treatment duration
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    16 [22]
    17 [23]
    40 [24]
    39 [25]
    Units: participants
        number (not applicable)
    9
    15
    34
    33
    Notes
    [22] - ITT population
    [23] - ITT population
    [24] - ITT population
    [25] - ITT population
    No statistical analyses for this end point

    Secondary: Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration

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    End point title
    		 Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
    End point description
    Number of days of concomitant medications use reported by participants at all visits via diaries.
    End point type
    Secondary
    End point timeframe
    12 month treatment duration
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    3 [26]
    2 [27]
    5 [28]
    9 [29]
    Units: days
        arithmetic mean (standard deviation)
    7.3 ± 4.62
    16.5 ± 19.09
    28.0 ± 35.67
    16.3 ± 17.35
    Notes
    [26] - Number of patients requiring oral systemic corticosteroids within the ITT Pediatric population.
    [27] - Number of patients requiring oral systemic corticosteroids within the ITT Pediatric population.
    [28] - Number of patients requiring oral systemic corticosteroids within the ITT Adult population.
    [29] - Number of patients requiring oral systemic corticosteroids within the ITT Adult population.
    No statistical analyses for this end point

    Secondary: Asthma Control Questionnaire (ACQ) at Baseline

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    End point title
    		 Asthma Control Questionnaire (ACQ) at Baseline
    End point description
    The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. Baseline summaries are presented only due to early termination of the trial. Participant responses to five ACQ questions were used in the calculations. Patient responses to ACQ questions 6 and 7 were not available for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    15 [30]
    17 [31]
    40 [32]
    39 [33]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    3.3 ± 1.31
    3.3 ± 1.26
    3.6 ± 1.09
    3.3 ± 1.35
    Notes
    [30] - Number of participants with a baseline measurement within the ITT Pediatric population.
    [31] - Number of participants with a baseline measurement within the ITT Pediatric population.
    [32] - Number of participants with a baseline measurement within the ITT Adult population.
    [33] - Number of participants with a baseline measurement within the ITT Adult population.
    No statistical analyses for this end point

    Secondary: Asthma Quality of Life Questionnaire (AQLQ) at Baseline

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    End point title
    		 Asthma Quality of Life Questionnaire (AQLQ) at Baseline
    End point description
    The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ[S]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items. Note: Environment domain is non-existent for pediatric population. Baseline summaries are presented only due to early termination of the trial.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Number of subjects analysed
    15 [34]
    17 [35]
    40 [36]
    39 [37]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Overall
    3.2 ± 1.21
    3.4 ± 1.54
    2.9 ± 1.04
    3.4 ± 1.25
        Symptoms domain
    3.2 ± 1.49
    3.3 ± 1.48
    2.8 ± 1.16
    3.5 ± 1.37
        Activity limitations domain
    3.2 ± 1.18
    3.3 ± 1.47
    3.2 ± 1.07
    3.5 ± 1.25
        Emotional functions domain
    3.2 ± 1.47
    3.6 ± 1.76
    2.5 ± 1.16
    3.2 ± 1.49
        Environmental stimuli domain
    0 ± 0
    0 ± 0
    2.7 ± 1.24
    3.1 ± 1.47
    Notes
    [34] - Number of participants with a baseline measurement within the ITT Pediatric population.
    [35] - Number of participants with a baseline measurement within the ITT Pediatric population.
    [36] - Number of participants with a baseline measurement within the ITT Adult population.
    [37] - Number of participants with a baseline measurement within the ITT Adult population.
    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 .
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    na
    Reporting groups
    Reporting group title
    Pediatric Patients: Omalizumab + Budesonide and Formoterol
    Reporting group description
    		 Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Pediatric Patients: Budesonide and Formoterol
    Reporting group description
    		 Participants received budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Adult Patients: Omalizumab + Budesonide and Formoterol
    Reporting group description
    		 Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.

    Reporting group title
    Adult Patients: Budesonide and Formoterol
    Reporting group description
    		 Participants receive budesonide + formoterol administered through an inhaler device.

    Serious adverse events
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 17 (11.76%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Maternal exposure during pregnancy
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic inflammatory disease
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Expired product administered
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pediatric Patients: Omalizumab + Budesonide and Formoterol Pediatric Patients: Budesonide and Formoterol Adult Patients: Omalizumab + Budesonide and Formoterol Adult Patients: Budesonide and Formoterol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 16 (68.75%)
    7 / 17 (41.18%)
    27 / 40 (67.50%)
    21 / 39 (53.85%)
    Injury, poisoning and procedural complications
    Pruritus - injection site reaction
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Sea food allergy
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    2
    1
    Head trauma
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    0
    1
    Headache
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 17 (17.65%)
    5 / 40 (12.50%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    5
    3
    Insomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Lipothymia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    General disorders and administration site conditions
    Adynamia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    5 / 40 (12.50%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    5
    1
    Asthenia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    2
    1
    Fever
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    3 / 40 (7.50%)
    2 / 39 (5.13%)
         occurrences all number
    1
    0
    3
    2
    Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    2
    1
    Palpitations
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    4 / 40 (10.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    4
    1
    Tachycardia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    4 / 40 (10.00%)
    2 / 39 (5.13%)
         occurrences all number
    1
    0
    4
    2
    Eye disorders
    Burning in the eye
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Conjuntivitis - bacterial
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus - ocular
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain -localized
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Colitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Constipation
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Epigastric pain - food-related
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastroenteritis - acute
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastroesophageal reflux disease
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    3 / 40 (7.50%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    3
    1
    Hepatic steatosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    1
    Pyelonephritis - acute
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Erythema
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic asthma
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Asthma exacerbation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    4 / 40 (10.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    4
    1
    CRUP syndrome
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cough - dry
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Cough - with sputum
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    2
    2
    Dyspnea
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Flu illness
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Nasal congestion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    3 / 40 (7.50%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    3
    1
    Nasal obstruction
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    2
    1
    Nose bleeding
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Odinofagia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    5 / 40 (12.50%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Otorhinolaryngological examination
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rhinitis - acute
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    1
    0
    2
    Rhinitis - allergic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    4 / 40 (10.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    4
    1
    Rhinorrhea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    5 / 40 (12.50%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Rhinosinusitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    2
    1
    Runny nose
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    4 / 40 (10.00%)
    4 / 39 (10.26%)
         occurrences all number
    0
    1
    4
    4
    Sneezing
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    3 / 40 (7.50%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    3
    1
    Sore throat
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    5 / 40 (12.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    1
    5
    2
    Sputum
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    5 / 40 (12.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    1
    5
    2
    Sputum increase
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    5 / 40 (12.50%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    5
    1
    Skin and subcutaneous tissue disorders
    Pruritus - allergic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Endocrine disorders
    Increased hunger
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    4 / 40 (10.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    4
    1
    Musculoskeletal and connective tissue disorders
    Hands tremor
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Lower Limb cramp
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    0
    2
    3
    Muscle cramp
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    2
    1
    Muscle pain - localized
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Myalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pain - leg
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Pain - localized
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 17 (0.00%)
    5 / 40 (12.50%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    5
    0
    Tremor
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    2
    1
    Infections and infestations
    Diarrhea - Acute
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    External Otitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Flu - common
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    0
    0
    3
    Influenza virus infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    2
    1
    Pharyngitis - Acute
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    1
    Pharyngitis - bacterial
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 17 (5.88%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    1
    1
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 17 (5.88%)
    3 / 40 (7.50%)
    7 / 39 (17.95%)
         occurrences all number
    2
    1
    3
    7
    Rhinopharyngitis
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    0
    1
    Sore throat
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    4 / 40 (10.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    4
    1
    Tonsillitis - acute
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    flu-like symptoms
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    5 / 40 (12.50%)
    4 / 39 (10.26%)
         occurrences all number
    0
    0
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2013
    Updated with dose determination chart for appropriate omalizumab dose assignment for every 4 weeks and 2 weeks. The spirometry with a β2 reversibility test should be performed at the beginning of the study (Visit −1) as part of the asthma diagnosis and also at the final visit (Visit 20). Updated Schedule of evaluations. Additional laboratory evaluations for Hemogram and Allergens. Other administrative changes.
    29 Mar 2014
    Inclusion criteria. Change in dosage of budesonide and formoterol (mg to μg). Other administrative changes
    29 Aug 2014
    Novartis will provide Omalizumab (Xolair), Budesonide (Miflonide, Pulmicort or generic drugs equivalent to Budesonide) and Formoterol (Foradil or generic drug equivalent to Formoterol). Other administrative changes.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 Aug 2015
    A premature termination of clinical trial was done by the Sponsor for reasons unrelated to efficacy and/or drug safety. The main rationale behind premature termination was due to identified errors in data management handling after an internal audit by the sponsor performed by third party; validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning and decommissioning requirements were assessed according to ICH GCP E6 with significant findings.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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