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    Clinical Trial Results:
    A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma

    Summary
    EudraCT number
    		 2015-003538-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Mar 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025AIA05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    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
    03 Mar 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary safety objective was to confirm the safety of omalizumab during the 52 week double-blind treatment period and 16 week follow-up period. The primary efficacy objective was to demonstrate the effect of omalizumab on the clinically significant asthma exacerbation rate during the 24 week double-blind fixed steroid treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 290
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Brazil: 26
    Country: Number of subjects enrolled
    Argentina: 131
    Country: Number of subjects enrolled
    Colombia: 86
    Country: Number of subjects enrolled
    Poland: 69
    Worldwide total number of subjects
    628
    EEA total number of subjects
    69
    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)
    628
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 87 centers in 7 countries (Argentina - 8, Brazil - 3, Canada - 6, Colombia - 5, Poland - 6, United States - 58, and South Africa - 1).

    Pre-assignment
    Screening details
    		 Of 1433 subjects screened subjects, 805 subjects excluded: unacceptable medical history/concomitant diagnosis(22), Intercurrent medical event(20), unacceptable laboratory values (73), Unacceptable test procedure results(358), not met diagnostic/severity criteria (213), Unacceptable medication use (32), consent withdrawal(93), unknown(3), other(28).

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Assessor, Subject
    Blinding implementation details
    Unblinding was only to occur in the case of subjects emergencies and at the conclusion of the study and final data review.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omalizumab
    Arm description
    		 Omalizumab 75 to 375 mg was administered subcutaneously (sc) every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum IgE level at screening visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    IGE025
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omalizumab 75 to 375 mg was administered sc every 2 or 4 weeks depending on the dose. Omalizumab was supplied as a sterile, freeze-dried preparation that was reconstituted using sterile water for injection (WFI) to a final omalizumab concentration of 150 mg.

    Arm title
    		 Placebo
    Arm description
    		 Placebo solution was administered every 2 or 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo solution was administered every 2 or 4 weeks.

    Number of subjects in period 1
    		Omalizumab Placebo
    Started
    421
    207
    Completed
    352
    175
    Not completed
    69
    32
         Consent withdrawn by subject
    21
    7
         Adverse event, non-fatal
    2
    1
         Unsatisfactory therapeutic effect
    1
    2
         Administrative problems
    22
    11
         Subject's condition no longer requires study drug
    3
    -
         Lost to follow-up
    12
    5
         Protocol deviation
    8
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab 75 to 375 mg was administered subcutaneously (sc) every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum IgE level at screening visit.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo solution was administered every 2 or 4 weeks.

    Reporting group values
    		 Omalizumab Placebo Total
    Number of subjects
    		 421 207 628
    Age categorical
    Units: Subjects
        6 years to 9 years
    		 254 143 397
        10 years to 11 years
    		 167 64 231
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.7 ( 1.7 ) 8.4 ( 1.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 134 69 203
        Male
    		 287 138 425

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab 75 to 375 mg was administered subcutaneously (sc) every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum IgE level at screening visit.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo solution was administered every 2 or 4 weeks.

    Primary: Rate of clinically significant asthma exacerbations in the 24-week double-blind fixed steroid period

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    End point title
    		 Rate of clinically significant asthma exacerbations in the 24-week double-blind fixed steroid period
    End point description
    A clinically significant asthma exacerbation was defined as worsening of asthma symptoms based on investigator’s discretion as subjects requiring doubling of the baseline inhaled corticosteroid dose for at least 3 days and/or treatment with rescue systemic (oral or intravenous) corticosteroids. The initiation of the corticosteroid regimens marks the start of an asthma exacerbation and cessation of the additional corticosteroid regimens marks the end of an exacerbation. The analysis was performed in Modified Intent-to-treat (MITT) population defined as all subjects excluding subjects from GCP non-compliant sites who were randomized and were analyzed according to the randomized treatment. Subjects who discontinued prematurely were included in the analysis using an imputed number of clinically significant asthma exacerbation episodes. Here, ‘Number of subjects analysed’ signifies subjects evaluable for this parameter at defined time-frame for each arm, respect
    End point type
    Primary
    End point timeframe
    Baseline to Week 25 (24 Week treatment period)
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    384
    192
    Units: Exacerbation rate
        number (not applicable)
    0.45
    0.64
    Statistical analysis title
    		 Asthma exacerbations during 24 week
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    576
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Poisson regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.693
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.533
         upper limit
    		 0.903

    Primary: Number of subjects with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation and who died

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    End point title
    		 Number of subjects with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation and who died [1]
    End point description
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed on safety set population defined as all subjects who received at least one of the study treatment and had at least one post-baseline safety assessment.
    End point type
    Primary
    End point timeframe
    From start of study treatment to Week 52 (52 week treatment period), Follow-up period (16 Weeks)
    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: Only descriptive summary statistics was planned for this outcome measure.
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    421
    207
    Units: Subjects
        AEs
    380
    194
        SAEs
    17
    17
        Discontinuation due to AEs
    2
    1
        Discontinuation due to SAEs
    1
    1
        Deaths
    0
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in nocturnal clinical symptom score during 24 week double-blind fixed steroid treatment period

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    End point title
    		 Change from baseline in nocturnal clinical symptom score during 24 week double-blind fixed steroid treatment period
    End point description
    Patient diary was used to evaluate nocturnal clinical symptom using a question ‘How did you sleep last night?’ in morning. The responses were scored between 0 to 4 based on awakening during last night as score 0 = no awakening due to breathing problem; 1 = awoke once because of breathing problems but no rescue medication used; 2 = awoke once because of breathing problems but rescue medication controlled symptoms; 3 = awoke more than once because of breathing problems but rescue medication controlled symptoms; 4 = difficulty sleeping because of breathing problems even after use of rescue medication controlled symptoms. Subjects who discontinued prematurely were included in the analysis using an imputed number of clinically significant asthma exacerbation episodes. The analysis was performed in MITT population. Here, ‘Number of subjects analysed’ signifies subjects evaluable for this parameter at defined time-frame for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to end of the 24-week (mean of 4 weeks prior to week 24 or early discontinuation)
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    382
    191
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.63 ( 0.72 )
    -0.5 ( 0.71 )
    No statistical analyses for this end point

    Secondary: Clinically significant asthma exacerbation rate during 52 week double-blind treatment period

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    End point title
    		 Clinically significant asthma exacerbation rate during 52 week double-blind treatment period
    End point description
    A clinically significant asthma exacerbation was defined as worsening of asthma symptoms based on investigator’s discretion as subjects requiring doubling of the baseline inhaled corticosteroid dose for at least 3 days and/or treatment with rescue systemic (oral or intravenous) corticosteroids. The initiation of the corticosteroid regimens marks the start of an asthma exacerbation and cessation of the additional corticosteroid regimens marks the end of an exacerbation. The analysis was performed in MITT population. Subjects who discontinued prematurely were included in the analysis using an imputed number of clinically significant asthma exacerbation episodes. Here, ‘Number of subjects analysed’ signifies subjects evaluable for this parameter at defined time-frame for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    384
    192
    Units: Exacerbation rate
        number (not applicable)
    0.78
    1.36
    No statistical analyses for this end point

    Secondary: Change from baseline in rescue medication use to 24 week double-blind fixed steroid treatment period

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    End point title
    		 Change from baseline in rescue medication use to 24 week double-blind fixed steroid treatment period
    End point description
    β2-agonist rescue medication was used in inadequately controlled subjects defined as subjects who were partly controlled or uncontrolled according to Global Initiative for Asthma (GINA) guidelines (2007). Subjects who discontinued prematurely were included in the analysis using an imputed number of clinically significant asthma exacerbation episodes. The analysis was performed in MITT population. Here, ‘Number of subjects analysed’ signifies subjects evaluable for this parameter at defined time-frame for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to end of the 24-week (mean of 4 weeks prior to week 24 or early discontinuation)
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    381
    191
    Units: Number of puffs
        arithmetic mean (standard deviation)
    -1.3 ( 2.84 )
    -1 ( 2.5 )
    No statistical analyses for this end point

    Secondary: Change from baseline in quality of life score at the end of the 24-week fixed steroid treatment period

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    End point title
    		 Change from baseline in quality of life score at the end of the 24-week fixed steroid treatment period
    End point description
    Self-administered standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ) was administered to subjects regardless of age to evaluate QoL. The PAQLQ (Standardized version) was designed to measure the problems that children experienced as a result of their asthma. It comprises of 23 items in 3 domains symptoms (5 items), activity limitations (10 items), emotional function(8 items), each scored on a scale of 1 (severely affected) to 7 (unaffected). Final score ranges from 1–7 for each domain and for the whole instrument, where higher scores indicated better QoL. The analysis was performed in MITT population. Subjects who discontinued prematurely were included in the analysis using an imputed number of clinically significant asthma exacerbation episodes. Here, ‘Number of subjects analysed’ signifies subjects evaluable for this parameter at defined time-frame for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to end of the 24-week (mean of 4 weeks prior to week 24 or early discontinuation)
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    375
    187
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Activities
    0.8 ( 1.31 )
    0.8 ( 1.33 )
        Emotions
    0.9 ( 1.38 )
    0.9 ( 1.35 )
        Symptoms
    1 ( 1.33 )
    0.9 ( 1.34 )
        Overall
    0.9 ( 1.21 )
    0.9 ( 1.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV.
    Adverse event reporting additional description
    On-treatment Period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo solution was administered every 2 or 4 weeks.

    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab 75 to 375 mg was administered sc every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum IgE level at screening visit.

    Serious adverse events
    		 Placebo Omalizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 207 (12.56%)
    27 / 421 (6.41%)
         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)
    Medulloblastoma
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (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
    Head injury
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 207 (0.48%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope vasovagal
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (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
    18 / 207 (8.70%)
    17 / 421 (4.04%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tic
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 207 (0.48%)
    3 / 421 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 207 (0.48%)
    2 / 421 (0.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    0 / 207 (0.00%)
    2 / 421 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 207 (2.90%)
    3 / 421 (0.71%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    2 / 207 (0.97%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 421 (0.24%)
         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: 5%
    Non-serious adverse events
    		 Placebo Omalizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    194 / 207 (93.72%)
    374 / 421 (88.84%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    33 / 207 (15.94%)
    58 / 421 (13.78%)
         occurrences all number
    60
    96
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    20 / 207 (9.66%)
    59 / 421 (14.01%)
         occurrences all number
    30
    78
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    12 / 207 (5.80%)
    23 / 421 (5.46%)
         occurrences all number
    21
    27
    Diarrhoea
         subjects affected / exposed
    12 / 207 (5.80%)
    20 / 421 (4.75%)
         occurrences all number
    12
    24
    Vomiting
         subjects affected / exposed
    24 / 207 (11.59%)
    34 / 421 (8.08%)
         occurrences all number
    26
    41
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    170 / 207 (82.13%)
    290 / 421 (68.88%)
         occurrences all number
    975
    1526
    Cough
         subjects affected / exposed
    25 / 207 (12.08%)
    44 / 421 (10.45%)
         occurrences all number
    31
    56
    Pharyngolaryngeal pain
         subjects affected / exposed
    16 / 207 (7.73%)
    33 / 421 (7.84%)
         occurrences all number
    18
    42
    Rhinitis allergic
         subjects affected / exposed
    19 / 207 (9.18%)
    35 / 421 (8.31%)
         occurrences all number
    23
    45
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    29 / 207 (14.01%)
    36 / 421 (8.55%)
         occurrences all number
    33
    41
    Ear infection
         subjects affected / exposed
    11 / 207 (5.31%)
    22 / 421 (5.23%)
         occurrences all number
    13
    23
    Gastroenteritis
         subjects affected / exposed
    15 / 207 (7.25%)
    19 / 421 (4.51%)
         occurrences all number
    15
    23
    Gastroenteritis viral
         subjects affected / exposed
    7 / 207 (3.38%)
    23 / 421 (5.46%)
         occurrences all number
    7
    31
    Influenza
         subjects affected / exposed
    28 / 207 (13.53%)
    51 / 421 (12.11%)
         occurrences all number
    53
    79
    Nasopharyngitis
         subjects affected / exposed
    56 / 207 (27.05%)
    117 / 421 (27.79%)
         occurrences all number
    98
    202
    Pharyngitis
         subjects affected / exposed
    18 / 207 (8.70%)
    36 / 421 (8.55%)
         occurrences all number
    24
    38
    Pharyngitis streptococcal
         subjects affected / exposed
    13 / 207 (6.28%)
    19 / 421 (4.51%)
         occurrences all number
    17
    26
    Rhinitis
         subjects affected / exposed
    20 / 207 (9.66%)
    25 / 421 (5.94%)
         occurrences all number
    34
    36
    Sinusitis
         subjects affected / exposed
    38 / 207 (18.36%)
    70 / 421 (16.63%)
         occurrences all number
    57
    91
    Tonsillitis
         subjects affected / exposed
    11 / 207 (5.31%)
    7 / 421 (1.66%)
         occurrences all number
    15
    7
    Upper respiratory tract infection
         subjects affected / exposed
    46 / 207 (22.22%)
    68 / 421 (16.15%)
         occurrences all number
    62
    95
    Viral upper respiratory tract infection
         subjects affected / exposed
    26 / 207 (12.56%)
    34 / 421 (8.08%)
         occurrences all number
    39
    41

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jul 2004
    The aim of this amendment was to: • adjust the regression model used for statistical analysis of the primary efficacy variable • make some minor adjustments to the inclusion and exclusion criteria • clarify study procedure in the event of a low platelet count • make adjustment to the statistical analysis including regarding the handling of missing values, censoring of observations, and treatment of data from subjects who discontinued (e.g. imputation procedure for exacerbation episodes) • Safety parameters ( (malignancies, platelet decreases and SAEs) originally planned to be included in the Data Safety Monitoring Board (DSMB) review were to be reviewed in an ongoing manner by Novartis personnel.

    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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