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    Summary
    EudraCT Number:2011-001682-41
    Sponsor's Protocol Code Number:HLS03/2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001682-41
    A.3Full title of the trial
    Comparison of the efficacy and the safety of different schedules of administration of sub-lingual immunotherapy in patients with ragweed pollinosis: a phase III randomized and controlled clinical study.
    Confronto dell`efficacia e della sicurezza di diversi schemi di somministrazione dell`immunoterapia sub-linguale in pazienti con pollinosi da ambrosia: studio clinico randomizzato controllato di fase III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of different regimens of sublingual immunotherapy for Ragweed.
    Confronto dell'efficacia e della sicurezza di diversi schemi di immunoterapia sublinguale per Ambrosia.
    A.4.1Sponsor's protocol code numberHLS03/2011
    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 SponsorAZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    B.1.3.4CountryItaly
    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 supportASIA Onlus
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale Luigi Sacco
    B.5.2Functional name of contact pointS.S. Allergologia-Immunologia Clin.
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Grassi 74
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.4Telephone number02-39043490
    B.5.5Fax number02-39042568
    B.5.6E-mailiemoli.enrico@hsacco.it
    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 No
    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 nameRagweed estract
    D.3.4Pharmaceutical form Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMBROSIA ARTEMISIIFOLIA L.
    D.3.10 Strength
    D.3.10.1Concentration unit SU Standardised Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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
    Subjects who are allergic to Ragweed.
    Soggetti allergici ad Ambrosia.
    E.1.1.1Medical condition in easily understood language
    Ragweed allergic subjects.
    Allergici ad Ambrosia.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually vs oral-vestibular;
    Assess the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually at a dose doubled 400 STU/dose vaccine compared to the commonly used marketing 200 STU/dose.
    Valutare la percentuale di cellule CD14-PDL-1-IL10+ circolanti allergene-specifiche in pazienti allergici all'ambrosia sottoposti a ciclo pre-costagionale di SLIT somministrata per via sublinguale vs orale-vestibolare;
    Valutare la percentuale di cellule CD14-PDL-1-IL10+ circolanti allergene-specifiche in pazienti allergici all'ambrosia sottoposti a ciclo pre-costagionale di SLIT somministrata per via sublinguale a una dose raddoppiata 400 STU/dose rispetto al vaccino comunemente in uso in commercio 200 STU/dose.
    E.2.2Secondary objectives of the trial
    Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually;
    Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose;
    Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually;
    Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose.
    Valutazione della efficacia clinica nel gruppo di pazienti trattati con vaccino sublinguale per via vestibolare rispetto a quelli trattati per via sublinguale.
    Valutazione dell'efficacia clinica nel gruppo di pazienti trattati con vaccino sublinguale a dosaggio doppio rispetto a quelli con dosaggio standard.
    Valutazione della sicurezza e della tollerabilità nel gruppo di pazienti trattati con vaccino sublinguale per via vestibolare rispetto a quelli trattati per via sublinguale.
    Valutazione della sicurezza e della tollerabilità nel gruppo di pazienti trattati con vaccino sublinguale a dosaggio raddoppiato rispetto a quelli trattati con dosaggio standard.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults aged 18-55 years, known allergy to ragweed pollen, no immunotherapy or in progress prior to enrollement, symptoms of rhino/conjunctivitis with or without asthma.
    Adulti di età compresa tra i 18 e i 55 anni, allergia accertata all'Ambrosia, nessuna immunoterapia in corso o precedente l'arruolamento, sintomi di rino-congiuntivite con o senza asma.
    E.4Principal exclusion criteria
    Allergic to perennial allergens (moulds, mites and animal when exposed to the animal), patients with chronic diseases (infectious, autoimmune cancer, heart or kidney), pregnancy, chronic drug treatment with steroids and/or immunosuppressive drugs, oral diseases.
    Pazienti allergici ad allergeni perenni, pazienti affetti da malattie croniche, gravidanza in atto, trattamenti farmacologici cronici con steroidi o immunosoppressori, malattie del cavo orale.
    E.5 End points
    E.5.1Primary end point(s)
    The end of the study will detect a difference between groups with respect to the primary objective, the percentage of CD14-PDL-1-IL10 + outstanding of at least 25 percentile points.
    Alla fine dello studio si rileverà una differenza tra i gruppi di percentuale di cellule CD14-PDL-1-IL10+ circolanti pari almeno a 25 punti percentili.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At study termination (3 months).
    Al termine dello studio (3 mesi).
    E.5.2Secondary end point(s)
    None.
    Nessuno.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Non applicabile.
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    altra via di somministrazione. - Stesso farmaco ad altro dosaggio
    other mode of administration. - same IMP used at different dosage
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    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 2011-12-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    Subjects will continue the treatment of their Ragweed allergy according to the best clinical standard.
    Proseguiranno il trattamento dell'allergia ad Ambrosia secondo il miglior standard clinico.
    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 Decision2011-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
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