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    Summary
    EudraCT Number:2015-003533-10
    Sponsor's Protocol Code Number:CIGE025ABR01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-02-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-003533-10
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
    A.4.1Sponsor's protocol code numberCIGE025ABR01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis
    B.1.3.4CountryBrazil
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis
    B.4.2CountryBrazil
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinicaltrial.enquire@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xolair
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe persistent allergic asthma
    E.1.1.1Medical condition in easily understood language
    Allergic Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)
    E.2.2Secondary objectives of the trial
    1.Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks
    2.Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20
    3.The Mean Change From Baseline to the End of Study in AQLQ Domain Score
    4.Number of Asthma Exacerbation Episodes Per Participant
    5.Percentage of Participants Using Rescue Medication
    6.Free Days With no Rescue Medication
    7.Mean Number of Puffs of Rescue Medication Taken Per Day
    8.Physician's Global Assessment of Treatment Effectiveness
    9.Patient's Global Assessment of Treatment Effectiveness
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •12 to 75 years-old during screening visit.
    •Body weight > 20 kg and < 150 kg.
    •Daily or persistent asthma symptoms.
    •Night symptoms at least once a week.
    •Forced expiratory volume in 1 second (FEV1) > 40% and < 80% of
    predicted normal value and continuing asthma symptoms.
    •FEV1 increased > 12% from baseline within 30 minutes of inhaled (up
    to 400 mcg) or nebulized (up to 5 mg) salbutamol.
    •Subject taking more than 500 mcg/day of fluticasone or equivalent
    associated to a long-acting β2-agonist.
    •Inhaled corticosteroid and long-acting beta-2 adrenergic agonist
    (LABA) doses that remained fixed during the last 12 weeks prior to
    screening.
    •Medical history of at least two episodes of asthma exacerbation
    treated with systemic corticoid or at least one severe asthma
    exacerbation treated with systemic corticoid and hospitalization or
    emergency room visit in the last 12 months prior to screening.
    •Positive skin prick test (diameter of wheal > 3mm) to at least one
    perennial aeroallergen (dust mite, cat/dog dander, cockroaches), to
    which the subject was likely to be exposed during the study.
    •Subject capable to read and understand asthma related quality of life
    questionnaire (Juniper's questionnaire).
    Other protocol-defined inclusion criteria applied to the study
    E.4Principal exclusion criteria
    •Pregnant, nursing female subjects.
    •Female subjects without current acceptable contraceptive method.
    •Previous history of allergy or hypersensitivity to omalizumab.
    •Subjects with prior treatment with omalizumab.
    •Subjects with medical history of psychiatric disorder.
    •Subject had been treated with systemic corticosteroid for any reason
    other than asthma.
    •Subject took β2 antagonist medication in the last 3 months prior to
    screening visit.
    •Subject took protocol prohibited medication prior to screening.
    •Medical history of food or drug related severe anaphylactoid
    reactions.
    •Medical history of antibiotics allergy. Patients were included if the
    antibiotics to which they were allergic to were to be avoided for the
    entire duration of the study.
    •Asthma related to non-steroidal anti-inflammatory drug (NSAID).
    •Treatment of exacerbation in the 4 weeks prior to randomization.
    •Other active lung diseases.
    •Medical history of others uncontrolled diseases 3 months prior
    randomization (eg, infections, coronary heart diseases and metabolic
    diseases).
    •Any history of cancer.
    •Abnormal electrocardiogram (ECG), laboratory exams (clinically
    significant abnormalities), and chest X-ray (CXR).
    •Evidence or history of drug or alcohol abuse.
    •Airway infection (eg, pneumonia, acute sinusitis) 4 weeks prior to
    screening visit.
    •Smokers or smoking history of > 10 pack-years.
    •Subject that had been treated with investigational drugs over the past
    30 days or during the course of the trial.
    •Subject had elevated IgE levels for reasons other than allergy.
    Other protocol-defined exclusion criteria applied to the study.
    E.5 End points
    E.5.1Primary end point(s)
    The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and week 20
    E.5.2Secondary end point(s)
    1.Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks
    2.Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20
    3.The Mean Change From Baseline to the End of Study in AQLQ Domain Score
    4.Number of Asthma Exacerbation Episodes Per Participant
    5.Percentage of Participants Using Rescue Medication
    6.Free Days With no Rescue Medication
    7.Mean Number of Puffs of Rescue Medication Taken Per Day
    8.Physician's Global Assessment of Treatment Effectiveness
    9.Patient's Global Assessment of Treatment Effectiveness
    E.5.2.1Timepoint(s) of evaluation of this end point
    - for secondary endpoinds 1, 2, and 3 as listed in E.5.2 - timepoints:
    baseline and week 20
    - for secondary endpoinds 4,5,6 and 7 as listed in E.5.2 - timepoints:
    from baseline through week 20
    - for secondary endpoinds 8 and 9 as listed in E.5.2 - timepoints: 20
    weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Brazil
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 123
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Brazil
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