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    Summary
    EudraCT Number:2012-001591-11
    Sponsor's Protocol Code Number:3.4.11.049
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-19
    Trial 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001591-11
    A.3Full title of the trial
    Symptomatic treatment of pollen related allergic rhinoconjunctivitis and the relation with asthma with children in the General practice
    Symptomatische behandeling van pollen gerelateerd allergische rhinoconjuctivitis en de relatie met astma bij kinderen in de huisartspraktijk
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of hay fever and the relation with asthma in children in de general practice office
    Behandeling van hooikoorts en de relatie met astma bij kinderen in de huisartspraktijk
    A.3.2Name or abbreviated title of the trial where available
    HATSJOE
    HATSJOE
    A.4.1Sponsor's protocol code number3.4.11.049
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:3429
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstma Fonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointDepartment of General Practice
    B.5.3 Address:
    B.5.3.1Street AddressBurg s'Jacobsplein 51
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031107031897
    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 Xyzal
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.1Product nameLevocetirizine
    D.3.2Product code RVG 26770
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Flixonase
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.1Product nameFluticasone
    D.3.2Product code RVG 14424
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Allergic Rhinitis
    Asthma
    Allergische rinitis
    Astma
    E.1.1.1Medical condition in easily understood language
    Hay fever and asthma
    hooikoorts en astma
    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
    It has been suggested that adequate treatment of AR might be beneficial for the lower airways. Whereas INCS and perhaps antihistamines may be a promising additive treatment to reduce asthma symptoms in patients with rhinitis and mild asthma, more research is needed.
    This study consists of two research questions:
    Which treatment (antihistamines/INCS on demand/INCS continuously) is most effective in children with AR due to pollen allergy under treatment by the general practitioner?
    What is the effectiveness of AR treatment on asthma symptoms and asthma control in patients with AR and concomitant asthma?
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children aged 6-18 years
    - Recruitment in general practice based on doctor’s diagnosis AR (ICPC R97) or prescription of allergy medication (antihistamines, INCS) in the last year.
    - Sensitization to grass pollen or grass and tree pollen (determined by CAP-RAST, class >= 2).
    - Present symptoms of allergic rhinitis and conjunctivitis. Severity will be determined by a retrospective symptom score (patients have to recall their complaints during the previous hay fever season). Seven complaints of nose (sneezing, nose blockage, runny nose, itching nose) and eye (itching eyes, redness and tearing eyes), will be determined. Each symptom is recorded on a scale from 0 to 3. A minimum of 7 out of the maximum of 21 points is required to be included in the study.
    - Informed consent
    E.4Principal exclusion criteria
    - Use of INCS one month prior to randomization or antihistamines one week prior to randomization
    - Currently pregnant or breastfeeding
    - Spending a significant amount of time abroad during the study period
    - Not able to speak and understand the Dutch language sufficiently
    - Not having internet access to fill in the diary and questionnaires
    E.5 End points
    E.5.1Primary end point(s)
    Research Question 1.
    Percentage of (nose and eye) symptom free days during the tree and/or grass pollen season.
    Research Question 2.
    Asthma control.
    Onderzoeksvraag 1.
    Percentage van (neus en oog) symptoom vrije dagen gedurende 3 maanden in het boompollen / graspollen seizoen.
    Onderzoeksvraag 2.
    Astma controle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily for diary questions or monthly for questionnaires
    Dagelijks voor dagboek en maandelijks voor vragenlijst
    E.5.2Secondary end point(s)
    Allergy symptom score, (rescue)medication free days, AR-specific quality of life, patient’s preference of medication.
    Outcomes regarding the effectiveness of AR-treatment on asthma: % days without asthma symptoms, asthma symptom score, asthma medication free days, asthma quality of life, and degree of asthma control.

    Allergie symptoomscore, (rescue)medicatie vrije dagen, AR-specifieke kwaliteit van leven, patiënten voorkeur voor medicatie.
    Uitkomstmaten met betrekking tot AR-behandeling op astma: % dagen zonder astma symptomen, astma symptoomscore, astma medicatie vrije dagen, astma-specifieke kwaliteit van leven, mate van astma controle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily for diary questions or monthly for questionnaires
    Dagelijks voor dagboek en maandelijks voor vragenlijst
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    E.8.1.3Single blind Yes
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    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: 411
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 205
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 206
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-07-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.4.1In the member state411
    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
    geen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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