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    Summary
    EudraCT Number:2012-005678-76
    Sponsor's Protocol Code Number:AIFANumberFARM94793N
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-29
    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 number2012-005678-76
    A.3Full title of the trial
    Twenty-four month, multicenter, prospective, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy, safety, tolerability, and cost-effectiveness of allergen specific sublingual immunotherapy (SLIT) in combination with standard of care (SoC) in pediatric allergic asthma
    Studio multicentrico prospettico, randomizzato, in doppio cieco, controllato vs. placebo, per gruppi paralleli della durata di 24 mesi per valutare l’efficacia, la sicurezza, la tollerabilità, e il costo-efficacia dell’immunoterapia sublinguale allergene-specifica (SLIT) in associazione al trattamento standard nell’asma allergico pediatrico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SUBLINGUAL IMMUNOTHERAPY IN PEDIATRIC ASTHMA
    Immunoterapia sublinguale nell'asma pediatrico
    A.3.2Name or abbreviated title of the trial where available
    SUBLINGUAL IMMUNOTHERAPY IN PEDIATRIC ASTHMA
    Immunoterapia sublinguale nell'asma pediatrico
    A.4.1Sponsor's protocol code numberAIFANumberFARM94793N
    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 SponsorALLEGRIA onlus
    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 supportAIFA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto G. Gaslini
    B.5.2Functional name of contact pointClinical Pharmacology&Trials
    B.5.3 Address:
    B.5.3.1Street Addressvia G. Gaslini 3-5
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16147
    B.5.3.4CountryItaly
    B.5.4Telephone number+390105636461
    B.5.5Fax number+390103776590
    B.5.6E-mailornelladellacasa@ospedale-gaslini.ge.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 nameStaloral 300 acari
    D.3.2Product code Sublingual solution of HDM Allergen Extracts
    D.3.4Pharmaceutical form Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual 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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral drops
    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
    Allergic asthma to house dust mites
    Asma allergico agli acari della polvere
    E.1.1.1Medical condition in easily understood language
    Allergic asthma
    Asma allergico
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003558
    E.1.2Term Asthma extrinsic
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    It is to evaluate the long-term effectiveness either of SLIT or placebo in pediatric allergic asthma, i.e. the sparing effect of asthma-controller medications (either inhaled or oral CS, long-acting bronchodilators, and leukotriene modifiers) and asthma-relievers (rapid-acting bronchodilators) over 24 months.
    Obiettivo principale: Valutare l’efficacia a 2 anni dell’immunoterapia sublinguale allergene-specifica (SLIT) in confronto a placebo nel trattamento dell’asma pediatrico, efficacia intesa come ‘risparmio’ dell’uso di farmaci “asthma controller” (corticosteroidi inalatori e orali, broncodilatatori a lunga durata d’azione, anti-leucotrienici) e della terapia sintomatica dell’asma con broncodilatatori ad azione rapida.
    E.2.2Secondary objectives of the trial
    They will be the evaluation of:
    - Asthma symptoms and signs control (by the patient’s and proxy assessment of the Asthma Control Test-ACT and Childhood-ACT, and by the Allergy Symptom Assessment – i.e. the patient’s & proxy daily diary;
    - Asthma exacerbation episodes (i.e., implying the use of oral CS);
    - Changes in asthma medication prescription;
    - Long-term tolerability and safety profile of SLIT (frequency of adverse events- AEs and serious AEs);
    - Rhinoconjunctivitis symptoms and signs (using the physician assessed clinical score) and their control through the sparing of rhinoconjunctivitis medications;
    - SLIT effects on child’s and his/her family’s QoL;
    - Changes in skin test reactivity patterns at Month 24;
    - SLIT adherence over 24 months;
    - The budget impact in the NHS perspective of pediatric allergic asthma resulting from the use of SLIT;
    -To model cost-effectiveness of SLIT for the treatment of pediatric allergic asthma up to 24 months
    Valutare:
    -sintomi e segni dell’asma e controllo della malattia
    -episodi di esacerbazione (attacco) di asma
    -variazioni nell’uso di farmaci “asthma controller”
    -tollerabilità a lungo termine e profilo di sicurezza della SLIT
    -sintomi e segni di rinocongiuntivite e suo controllo attraverso la SLIT nel consentire il risparmio della terapia per la rinocongiuntivite
    -effetto della SLIT sulla qualità di vita del bambino e della sua famiglia
    -variazioni nel profilo di reattività cutanea mediante prick test cutaneo al mese 24
    -aderenza (compliance) alla SLIT nel corso dei 24 mesi di studio
    -impatto economico del trattamento con SLIT nell’asma pediatrico dal punto di vista del Sistema Sanitario Nazionale;
    - modello di cost-effectiveness applicato alla terapia con SLIT nell'asma allergico pediatrico a 24 mesi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Parents’/guardian’s written informed consent, and child’s assent given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care;
    - Age 5 - <18 years;
    - Males or females;
    - Outpatient status at the time of enrolment;
    - Allergic asthma diagnosed by the physician according to the GINA guidelines (2) at least one year prior to study entry;
    - Either presenting or not with concomitant allergic rhinoconjunctivitis;
    - Mono-sensitization to HDM, assessed by skin prick testing (wheal diameter > 3 mm) and/or by ImmunoCAP (specific IgE > 3.5 kU/L)
    - Clinically stable asthma, with either FEV1>80% predicted or ACT / C-ACT value > 20;
    - Records’ availability for asthma treatments since one year prior to study entry.
    - Consenso/ assenso informato
    -Età: 5-<18 anni
    -Maschi e femmine
    - in regime di DH
    -Affetti da asma allergico diagnosticato dal medico secondo le linee guida GINA almeno da un anno
    -Affetti o meno da rinocongiuntivite allergica
    -Monosensibilizzazione positiva agli acari della polvere valutata da Prick Test cutaneo (diametro del pomfo > 3 mm) e/o da ImmunoCAP (IgE allergene- specifiche >3,5 kU/L)
    -Asma clinicamente stabile con FEV1>80 (% predetto) o Asthma Control Test (ACT o Childhood-ACT) >20
    -Tracciabilità in cartella clinica (dati sorgente) dell’uso di farmaci “asthma controller” nell’anno precedente l’ingresso in studio.
    E.4Principal exclusion criteria
    - Actual uncontrolled or severe asthma (FEV1 < 70 %);
    - History of poor compliance;
    - History of malignancy (active malignancy, or off therapy since less than one year);
    - History of autoimmune diseases, immune complex diseases or immune deficiency diseases;
    - History of infectious diseases (including opportunistic infections) within four weeks prior to study entry;
    - Cystic fibrosis;
    - Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis
    - Any other relevant medical condition representing a contraindication to SIT according to guidelines;
    - Previous courses of SIT;
    - History of hypersensitivity to any of the excipients of the study therapy;
    - Chronic therapy with systemic CS or immunosuppressive drugs and agents;
    - Ongoing treatment with beta-blockers (including ocular topics);
    - Use of any investigational drug, device or biologic within 12 months prior to study entry or during the study.
    -Asma grave al momento del possibile arruolamento
    -Storia di scarsa compliance
    -Storia di neoplasia (neoplasia in corso o non trattata da meno di 1 anno)
    -Storia di patologie autoimmuni e gravi immunodeficienze
    -Storia di patologie infettive (incluso le infezioni opportunistiche) nelle 4 settimane antecedenti l’arruolamento
    -Fibrosi cistica
    -Malattie infiammatorie del cavo orale (lichen planus, micosi orali)
    -Qualunque altra condizione che rappresenti una contro-indicazione all’immunoterapia specifica (SIT)
    -Precedenti trattamenti con SIT
    -Storia di ipersensibilità verso qualunque eccipiente della SLIT
    -Terapia cronica con corticosteroidi sistemici o farmaci immunosoppressori
    -Terapia con beta bloccanti
    -Uso di qualunque farmaco, dispositivo o agente biologico in uso sperimentale nell’anno precedente l’arruolamento o durante lo svolgimento dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Effectiveness of either SLIT or placebo added on to asthma SoC therapies for the allergic asthma control improvement will be evaluated by means of the percentage of children with allergic asthma who will have a reduction from baseline of at least 50% in inhaled CS (iCS) doses or a withdrawal of asthma-controller medications (i.e. responders)
    Efficacia intesa come miglior controllo dell’asma con la SLIT in confronto a placebo aggiunti alla terapia standard (farmaci “asthma controller”). Il miglioramento sarà valutato come percentuale di bambini e adolescenti con asma allergico e/o rinocongiuntivite che avranno una riduzione di almeno il 50% della dose di corticosteroidi inalatori rispetto al basale o una sospensione dell’uso di farmaci “asthma controller” .
    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 24
    A 24 mesi
    E.5.2Secondary end point(s)
    Other study outcomes and related endpoints will be the longitudinal assessments during 24-month treatment of the following:
    - The Asthma Control Test (ACT);
    - Number of asthma exacerbation episodes or asthma attacks by means of the measurement of oral CS use, according to Global Initiative Guidelines in Asthma (GINA);
    - Changes in asthma SoC treatments;
    - Frequency of AEs and SAEs;
    - The Rhinoconjunctivitis Score (Total 5 Symptom Score - T5SS);
    - Changes in rhinoconjunctivitis medications;
    - The Allergy Symptom Assessment, i.e. the patient’s & proxy diary;
    - Child’s and his/her family’s quality of life (QoL), e.g. the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and the Pediatric Asthma Caregivers QoL Questionnaire (PACQLQ);
    - Changes in skin test reactivity patterns at Month 24 (onset of neosensitizations);
    - SLIT accountability and adherence over 24 months (defined as > 70% of the study medication taken per treatment course);
    - The cost of illness (COI) evaluation.
    -Asthma control test (ACT) e Childhood-ACT (C-ACT)
    -Numero di episodi di esacerbazione/attacchi di asma attraverso la valutazione del ricorso ai corticosteroidi orali secondo le linee guida GINA
    -Variazioni dell’uso dei farmaci “asthma controller”
    -Score della rinocongiuntivite (Total 5 Symptom Score – T5SS)
    -Variazioni dell’uso di farmaci per il trattamento della rinocongiuntivite
    -Valutazione dei sintomi allergici (diario quotidiano somministrato al paziente e al prestatore di cure)
    -Valutazione della qualità della vita del bambino/adolescente e della sua famiglia mediante i questionari Pediatric Asthma Quality of Life Questionnaire (PAQLQ) e il Pediatric Asthma Caregivers QoL Questionnaire (PACQLQ)
    -Variazione rispetto al basale nel profilo di reattività cutanea valutato mediante skin prick test a 24 mesi con valutazione di insorgenza di eventuali nuove sensibilizzazioni
    -Compliance alla SLIT nei 24 mesi di studio (almeno il 70% delle dosi di SLIT siano assunte dal paziente fra una visita e la successiva).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At screening visit (one month prior to baseline), at baseline visit, and at month-3,-6,-12,-18 and -24 visits, and at post treatment visitb one month after the IMP interruption.
    Alle visite di screening (1 mese prima del basale), alla visita basale, e alle visite dei mesi 3,6,12,18 e 24 e nella visita post trattamento a un mese dalla sospensione dell’IMP.
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned10
    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
    ultima visita dell'ultimo soggetto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 170
    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: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric subjects
    Soggetti in età pediatrica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state170
    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)
    Standard of care according to the indication exstrinsic asthma
    Terapia standard secondo l’indicazione ”asma estrinseco”.
    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 Decision2013-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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