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    Clinical Trial Results:
    Effect of Omalizumab in patients with Aspirin-Exazerbated Respiratory Disease (AERD)

    Summary
    EudraCT number
    		 2017-003119-21
    Trial protocol
    		 AT  
    Global end of trial date
    31 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2026
    First version publication date
    04 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Univ.Prof. Dr. Georg Stingl, Medical University of Vienna, 0043 14040077050, georg.stingl@meduniwien.ac.at
    Scientific contact
    Univ.Prof. Dr. Georg Stingl, Medical University of Vienna, 0043 14040077050, georg.stingl@meduniwien.ac.at
    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
    31 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the efficacy of omalizumab in patients with AERD regarding intolerance of salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment.
    Protection of trial subjects
    Following comprehensive instruction regarding the nature, significance, impact and risks of this clinical trial, the patient must have given written consent to participation in the study. During the instruction the trial participants were to be made aware of the fact that they can withdraw their consent – without giving reasons – at any time without their further medical care being influenced in any way. In addition to the comprehensive instructions was given to the trial participants by the Investigator, the trial participants also receive a written patient information sheet in comprehensible language, explaining the nature and purpose of the study and its progress. The patients must have agreed to the possibility of study-related data being passed on to relevant authorities. The patients must have been informed in detail of their obligations in relation to the trial participants insurance in order not to jeopardize insurance cover.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2017
    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
    Austria: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    0
    Adults (18-64 years)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Before study initiation, informed consent was obtained from all subjects. All patients with AERD could have been included according to inclusion- and exclusion criteria. AERD patients who had already obtained omalizumab for the treatment of asthma were also included and evaluated retrospectively.

    Pre-assignment
    Screening details
    		 The first visit was performed at screening (day 0, V1/before omalizumab therapy). Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C) were ruled out prior to the first dose.

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

    Arms
    Arm title
    		 Omalizumab
    Arm description
    		 Xolair (Omalizumab) Individual dosing according to IgE levels and body weight Administered subcutaneous every 2-4 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Xolair (Omalizumab) Individual dosing according to IgE levels and body weight Administered subcutaneous every 2-4 weeks

    Number of subjects in period 1
    		Omalizumab
    Started
    33
    Completed
    33

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Xolair (Omalizumab) Individual dosing according to IgE levels and body weight Administered subcutaneous every 2-4 weeks

    Subject analysis set title
    Before Omalizumab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients before omalizumab therapy

    Subject analysis set title
    after omalizumab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    after 6 months of omalizumab

    Primary: Omalizumab Effect on aspirin tolerance in atopic and nonatopic N-ERD patients

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    End point title
    		 Omalizumab Effect on aspirin tolerance in atopic and nonatopic N-ERD patients
    End point description
    As primary endpoint, the efficacy of omalizumab in patients with aspirin intolerance will be evaluated by oral exposure to low-dose acetylsalicylic acid before and after 6 months of treatment. At both timepoints, the dose of acetylsalicylic acid will be slowly increased until an intolerance reaction occurs or up to a maximum dose of 500mg and patients’ symptoms will be documented.
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Before Omalizumab after omalizumab
    Number of subjects analysed
    33
    33
    Units: number
    33
    33
    Statistical analysis title
    		 Induction of aspirin tolerance after omalizumab tr
    Comparison groups
    Before Omalizumab v after omalizumab
    Number of subjects included in analysis
    66
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.5
    Method
    		 Mcnemar
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded at each visit. There is no specific time frame.
    Adverse event reporting additional description
    Only 7 patients (19%) reported adverse events during omalizumab treatment. Four patients developed headaches between weeks 4 and 24, which occurred a few hours after injection and usually resolved within 1 day. Joint pain was reported by 3 patients, but only 1 patient had to discontinue treatment at week 20 owing to severe discomfort.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 visit protocoll
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 33 (21.21%)
    General disorders and administration site conditions
    headache
         subjects affected / exposed
    4 / 33 (12.12%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    joint pain
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3

    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.
    As a main limitation of this study, the lack of a placebo group must be mentioned, which was not included for ethical reasons because our patient population had already failed several treat- ment attempts.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34678497
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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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