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    Summary
    EudraCT Number:2004-004924-11
    Sponsor's Protocol Code Number:SHX0712
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-25
    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
    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 ConcernedGermany - PEI
    A.2EudraCT number2004-004924-11
    A.3Full title of the trial
    A multicentre, randomised, double-blind, placebo-controlled parallel group clinical trial to investigate the efficacy and safety of specific sublingual immunotherapy with SLIT One birch in patients with seasonal birch pollen induced rhinoconjunctivitis
    A.3.2Name or abbreviated title of the trial where available
    SLIT One Birch Study
    A.4.1Sponsor's protocol code numberSHX0712
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALK-Abelló A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameSLIT One birch
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetula verrucosa (Bet v 1)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000 to STU/ml
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Desensibilisierung gegenüber Allergenen
    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
    Nachweis der Wirksamkeit der sublingualen Immuntherapie mit SLIT One Birke im Vergleich zu Placebo bei Patienten mit allergischer Rhinokonjunktivitis mit oder ohne Asthma bronchiale aufgrund IgE-vermittelter Sensibilisierung gegenüber Allergenen von Frühblüherpollen anhand eines Rhinokonjunktivitis-Symptomscores sowie eines -Medikamentenscores während der Birkenpollensaison.
    E.2.2Secondary objectives of the trial
    • Auswertung verschiedener Aspekte der klinischen Symptomatik und des Medikamentenkonsums
    - Rhinokonjunktivitis-Symptomscore und -Medikamentenscore während der Peaksaison
    - Asthma-Symptomscore und -Medikamentenscore während der Birkenpollensaison
    - Asthma-Symptomscore und -Medikamentenscore während der Peaksaison
    - Rhinokonjunktivitis – VAS.
    • Nachweis einer verbesserten Lebensqualität durch die Immuntherapie (Juniper).
    • Nachweis einer Zunahme beschwerdefreier Tage während der Birkenpollensaison durch die Immuntherapie.
    • Nachweis einer gesteigerten Toleranz der konjunktivalen Provokation durch die Immuntherapie.
    • Untersuchung der Änderungen immunlaboratorischer Parameter unter Behandlung mit SLIT One.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Männliche und weibliche Patienten im Alter von 18 bis 65 Jahren, die ihre Einwilligung zur Teilnahme schriftlich gegeben haben und folgende Haupteinschlussbedingungen erfüllen:
    - Anamnese einer mittelschweren bis schweren Birkenpollenallergie über 2 Saisons oder länger, die eine symptomatische Behandlung während der Birkenpollensaison erforderte.
    - Nachweis einer IgE-vermittelten Sensibilisierung gegen Allergene von Birkenpollen durch
    1. einen positiven Hautpricktest (SPT) mit ALK-prick SQ Birke, d.h. Quaddel-durchmesser >= 3 mm
    UND
    2. einen positiven konjunktivalen Provokationstest (CPT) mit ALK-lyophilisiert SQ Birke auf einer Dosisstufe <= 100.000 SQ-U/ml
    UND
    3. positives spezifisches IgE gegenüber Birkenpollen (CAP-Klasse >= 2).
    E.4Principal exclusion criteria
    • FEV1 < 70% vom Sollwert.
    • Anamnese einer symptomatischen allergischen Rhinitis und/oder eines allergischen Asthma bronchiale aufgrund einer Sensibilisierung gegen Gräserpollen, die mit dem Start der Studienmedikation nach der Birkenpollensaison interferieren könnte.
    • Anamnese einer klinisch relevanten perennialen symptomatischen allergischen Rhinitis und/oder eines perennialen allergischen Asthma bronchiale aufgrund einer Sensibilisierung gegen Allergene, denen der Patient im täglichen Leben tatsächlich ausgesetzt ist.
    • Anamnese einer Notfallvisite oder eines Krankenhausaufenthalts wegen Asthma in den vergangenen 12 Monaten.
    E.5 End points
    E.5.1Primary end point(s)
    Rhinokonjunktivitis-Symptomscore; Rhinokonjunktivitis-Medikamentenscore
    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 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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Follow-up des AE-Status 1 Woche nach letztem Besuch (telefonisch)
    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 months2
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    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 2005-02-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state220
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-30
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