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    Summary
    EudraCT Number:2019-001532-65
    Sponsor's Protocol Code Number:LGT03-19
    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:2020-07-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001532-65
    A.3Full title of the trial
    A prospective, multicenter, double-blind, placebo-controlled randomized study to assess efficacy and safety of LAIS® Grass pollen tablets in patients with seasonal grass pollen-induced allergic rhinoconjunctivitis
    Studio prospettico, multicentrico, in doppio cieco, placebo-controllato, randomizzato per valutare l’efficacia e la sicurezza delle compresse di LAIS® Grass in pazienti con rinocongiuntivite allergica stagionale indotta dal polline di graminacee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of sublingual immunotherapy with LAIS® Grass pollen tablets in patients with seasonal grass pollen-induced allergic rhinoconjunctivitis
    Efficacia e Sicurezza dell'immunoterapia sublinguale con compresse di di LAIS® Grass in pazienti con rinocongiuntivite allergica indotta dal polline di graminacee
    A.3.2Name or abbreviated title of the trial where available
    LAIS® Grass pollen tablets in seasonal grass pollen-induced allergic rhinoconjunctivitis
    Compresse di LAIS® Grass in pazienti con rinocongiuntivite allergica indotta dal polline di graminac
    A.4.1Sponsor's protocol code numberLGT03-19
    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 SponsorLOFARMA S.P.A.
    B.1.3.4CountryItaly
    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 supportLofarma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCD PHARMA GROUP SRL
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressPIAZZA DE ANGELI, 7
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20146
    B.5.3.4CountryItaly
    B.5.4Telephone number0289051076
    B.5.5Fax number0289051088
    B.5.6E-mailinfo@cdpharma.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 nameLAIS Grass Sublingual Tablets
    D.3.2Product code [LAIS Grass]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLAIS Grass
    D.3.9.3Other descriptive nameLAIS Grass tablets
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 2
    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 AERIUS - 5 MG 20 COMPRESSE RIVESTITE CON FILM USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    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 nameDesloratadina
    D.3.2Product code [Desloratadina]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDesloratadina
    D.3.9.1CAS number 100643-71-8
    D.3.9.2Current sponsor codeDesloratadina
    D.3.9.3Other descriptive nameDesloratadine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 3
    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 NASONEX - SPRAY NASALE 0.05% 140 EROGAZIONI 50 MCG/SPRUZZO
    D.2.1.1.2Name of the Marketing Authorisation holderMSD ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMometasone Furoato
    D.3.2Product code [Mometasone Furoato]
    D.3.4Pharmaceutical form Nasal spray, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOMETASONE FUROATO
    D.3.9.1CAS number 105102-22-5
    D.3.9.2Current sponsor codeMometasone Furoato
    D.3.9.3Other descriptive namemometasone furoate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 4
    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 BF2 - 5 MG COMPRESSE 20 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBF RESEARCH S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePrednisone
    D.3.2Product code [Prednisone]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.2Current sponsor codePrednisone
    D.3.9.3Other descriptive namePrednisone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 5
    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 LEVOSTAB - 0.5 MG/ML SPRAY NASALE, SOSPENSIONE FLACONE 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderGRUNENTHAL ITALIA S.R.L.
    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 nameLevocabastina
    D.3.2Product code [Levocabastina]
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOCARNITINA CLORIDRATO
    D.3.9.1CAS number 79516-68-0
    D.3.9.2Current sponsor codeLevocabastina
    D.3.9.3Other descriptive nameLevocabastine
    D.3.10 Strength
    D.3.10.1Concentration unit Gtt drop(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    seasonal grass pollen-induced allergic rhinoconjunctivitis
    rinocongiuntivite allergica stagionale indotta dal polline di graminacee
    E.1.1.1Medical condition in easily understood language
    seasonal grass pollen-induced allergic rhinoconjunctivitis
    rinocongiuntivite allergica stagionale indotta dal polline di graminacee
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036019
    E.1.2Term Pollen allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy and safety of tablet-based sublingual immunotherapy (SLIT) with the monomeric allergoid LAIS® Grass tablets compared to placebo in patients with grass pollen-induced allergic rhinoconjunctivitis with or without controlled asthma
    L’obiettivo primario dello studio è di valutare l’efficacia e la sicurezza dell’immunoterapia sublinguale (SLIT) con compresse di allergoide monomerico LAIS® Grass comparata al placebo in pazienti con rinocongiuntivite allergica indotta da polline di graminacee in presenza o assenza di asma controllato.
    E.2.2Secondary objectives of the trial
    • Assessment of the correlation between extent of positivity to Nasal Provocation Test and efficacy of the therapy;
    • Assessment of average CSMS calculated on the 2 weeks with the highest symptom/medication scores of the placebo group at an individual site
    • Assessment of average CSMS calculated with alternative symptoms-medication scoring: dSS = 0-18 (runny nose, blocked nose, sneezing, itchy nose, ocular itching/grittiness/redness and ocular tearing, each assessed on a scale from 0 to 3), dMS = 0-20 (oral antihistamine score, 6; ocular antihistamines score, 6, nasal corticosteroid score, 8). Consequently, the CSMS ranges from 0 to 38;
    • Loss of asthma control (for asthmatic patients only) based on consensus-based GINA symptom control tool;
    • Assessment of primary and secondary endpoints in the age subgroup of adolescents
    • Valutazione della correlazione tra entità della positività al Test di Provocazione Nasale e l’efficacia della terapia;
    • Valutazione del CSMS medio calcolato nelle due settimane con i punteggi sintomi/terapia più alti del gruppo placebo in ogni singolo centro;
    • Valutazione del CSMS medio calcolato con un punteggio sintomo/terapia alternativo: dSS = 0-18 (naso che gocciola, naso congestionato, starnutazione, prurito al naso, prurito oculare/granulosità/rossore e lacrimazione; ognuno valutato con un scala da 0 a 3), dMS = 0-20 (punteggio antistaminico orale, 6; punteggio antistaminico oculare, 6, punteggio corticosteroide nasale, 8). Di conseguenza, il range CSMS da 0 a 38.
    • Perdita di asma controllato (solo per pazienti asmatici) basato sullo strumento di controllo dei sintomi GINA
    • Valutazione degli endopoint primari e secondari nel sottogruppo degli adolescenti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female (not breastfeeding, with negative urine pregnancy test and using either a highly effective method of contraception during the entire study or being post-menopausal for at least 1 year or sterilized women) or male patients, aged 12–64 years with a history of at least 2 years of grass pollen induced allergic rhinoconjunctivitis (ARC) with or without seasonal controlled allergic asthma [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2018. Available from: http://www.ginasthma.org],;
    2. Moderate/Severe (interfering with usual daily activities or sleep) ARC defined according to ‘Allergic Rhinitis and it impact on Asthma’ (ARIA) guidelines (Brozek et al., 2017)
    a) Requiring treatment (either antihistamines or nasal corticosteroids) during the grass pollen season and
    b) Retrospective Symptoms Score >10 out of pharmacotherapy or >4 under pharmacotherapy, as sum of the score (0-3) for each of the six nasal and conjunctival symptoms referred to the previous grass pollen season (range 0-18) (EMA/414476/2011);
    3. Positive clinical history of grass pollen allergy, proven by:
    • The majority of clinical symptoms appearing during the grass pollen season;
    • Specific IgE reactivity (immuneCAP) >= Class 2 to major allergens of Phleum pratense (if specific IgE have been recently examined in the year 2019 before the inclusion in the study, for instance at the moment of first clinical diagnosis, the results can be used as screening data);
    • Positive Skin Prick Test to Phleum pratense (or Grass mix extract including Phleum pratense) (wheal diameter >= 3 mm, negative control < 2 mm);
    • Positive reaction to Titrated Nasal Provocation Test (TNPT) with Lebel’s symptoms score (LSS) >=6;
    • Wash-out of pharmacological treatment interfering with the test is required prior to the SPT/TNPT (see dedicated section).
    4. Compliance and ability of the patient to complete a patient’s diary for self-evaluation of the symptoms and anti-symptomatic medication, and treatment compliance;
    5. Signed and dated patient´s Informed Consent
    Criteri di inclusione:
    1. Donne (non in allattamento, con test di gravidanza su urine negativo e che utilizzino un metodo contraccettivo altamente efficace durante l'intero studio o che siano in post-menopausa da almeno 1 anno o che siano sterili) o uomini, tra i 12 e i 64 anni con una storia di almeno 2 anni di rinocongiuntivite allergica indotta da polline di graminacee (ARC) con o senza asma allergico [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2018. Available from: http://www.ginasthma.org],;
    2. ARC Moderata/Grave (che interferisce con le normali attività giornaliere e/o il sonno) definita in accordo con le line guida ARIA “ Rinite allergica e suo impatto sull’Asma” (Brozek et al., 2017) e che
    a) richieda trattamento (antistaminici o corticosteroidi nasali) durante la stagione pollinica delle graminacee e
    b) con Punteggio retrospettivo dei sintomi >10 (se fuori da terapia farmacologica) o > 4 (se in terapia farmacologica), come somma del punteggio (0-3) per ognuno dei sei sintomi nasali e congiuntivali riferiti alla stagione pollinica delle graminacee precedente (range 0-18)(EMA/414476/2011);
    3. Storia clinica positiva di allergia a polline di graminacee, provata da:
    • La maggioranza di sintomi clinici che appaiono durante la stagione pollinica delle graminacee;
    • Reattività IgE specifica (ImmunoCAP) >= Classe 2 verso gli allergeni maggiori del Phleum pratense (se le IgE specifiche sono state recentemente esaminate nell’anno 2019 prima dell’inclusione nello studio, per esempio al momento della prima diagnosi clinica, i risultati possono essere usati allo screening));
    • Skin Prick Test positivo al Phleum pratense (o un mix di estratti che includono Phleum pratense) (diametro del pomfo >= 3 mm, controllo negativo < 2 mm);
    • Reazioni positive al Test di Provocazione Nasale (TNPT) con il punteggio dei sintomi di Lebel (LSS) >=6;
    • È richiesto il wash-out dal trattamento farmacologico che interferisce con il test prima del SPT/TNPT (vedere la sezione dedicate).

    4. Compliance e abilità del paziente nel completare il diario paziente per una auto-valutazione dei sintomi e della terapia antisintomatica, compliance al trattamento;
    5. Ottenimento del Consenso Informato firmato e datato.
    E.4Principal exclusion criteria
    Clinically relevant hypersensitivity to any of the excipients used in LAIS® Grass sublingual tablets or in placebo tablets (lactose monohydrate, cellulose microcrystalline, silica colloidal anhydrous and magnesium stearate);
    History of intolerance to the rescue medications (prednisone, desloratadine, mometasone, levocabastine) and solution for nasal test, or their excipients; conditions representing contraindications to the rescue medications;
    Previous immunotherapy with grass allergens or cross-reacting allergens within the last 5 years;
    Ongoing immunotherapy with any allergen;
    Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection;
    History of moderate to severe perennial allergic rhinitis requiring medication, caused by perennial allergen (i.e. house dust mites);
    History of clinically relevant allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed (i.e. pets’ and horse hair or dander);
    History of clinically relevant seasonal allergic rhinitis and/or asthma due to genuine sensitization to tree pollens (Oleaceae, Betulaceae Corylaceae Cupressaceae), main weed pollens (Urticacee), Chloridoideae grass pollen (Cynodon Dactylon), moulds (Alternaria),with diffusion adjacent to the start of and potentially overlapping the grass pollen season (each co-sensitization has to be evaluated for relevance with relation to the expected exposure in each geographic area and climatic zone; for example, a subject with positive skin test to Parietaria, history of symptoms clinically related to Parietaria exposure in a region with expected significant levels of Parietaria pollens has to be excluded);
    Symptoms of or treatment for acute inflammation of the nose, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process within 14 days of the baseline TNPT visit;
    Diagnosed of choanal atresia, nasal polyps, septal perforation, severe septal deviation, atrophic rhinitis, adenoids obstructing nasal ventilation;
    History of surgery either of paranasal sinus or of nasal turbinates, and/or elective maxillofacial surgery within 6 months before planned treatment start (randomization);
    Severe asthma or history of uncontrolled/partly controlled asthma within 3 months prior to screening (based on consensus-based GINA symptom control tool);
    History of chronic rhinosinisitit
    Ipersensibilità clinicamente rilevante agli eccipienti usati in LAIS® Grass compresse sublinguali o nelle compresse di placebo (lattosio monoidrato, cellulosa microcristallina, silice colloidale anidra e magnesio stearato);
    Storia di intolleranza alla terapia di supporto (prednisone, desloratadina, mometasone, levocabastina) e alla soluzione per il test nasale o i suoi eccipienti; condizioni che rappresentano controindicazioni alla terapia di supporto;
    Immunoterapia precedente con allergeni di graminacee o allergeni cross-reattivi entro 5 anni;
    Immunoterapia in corso con un allergene;
    Gravidanza in corso o desiderata, allattamento e/o mancanza di adeguata anticontraccezione;
    Storia di una rinite allergica perenne da moderata a grave che richieda terapia, causata da allergeni perenni (per esempio acari della polvere di casa);
    Storia di una rinite allergica clinicamente rilevante e/o asma causato da un allergene a cui il soggetto è regolarmente esposto (per esempio pelo o epitelio di animale domestico o di cavallo);
    Storia di una rinite allergica stagionale clinicamente rilevante e/o asma dovuto a una sensibilizzazione autentica ai pollini di alberi (Oleaceae, Betulaceae Corylaceae Cupressaceae), ai pollini delle principali erbe infestanti (Urticacee ), ai polline di erba Chloridoideae (Cynodon Dactylon), a muffe (Alternaria), con diffusione potenzialmente vicina o sovrapposta all’inizio della stagione pollinica delle graminacee (ogni co-sensibilizzazione va valutata per stabilirne la rilevanza in relazione all’esposizione attesa in ogni area geografica e zona climatica; per esempio, sarò escluso un soggetto con uno Skin Prick Test positivo per Parietaria , storia di sintomi clinicamente correlati alla esposizione alla Parietaria in una regione con significativi livelli attesi di pollini di Parietaria);
    Sintomi di o trattamento per infiammazione acuta del naso, infezione del tratto superiore delle vie respiratorie, sinusite acuta, otite media acuta, o altre infezioni rilevanti entro 14 giorni dalla visita TNPT di baseline;
    Atresia coanale diagnosticata, polipi nasali, perforazione del setto, grave deviazione del setto, rinite atrofica, adenoidi che ostruiscono la ventilazione nasale;
    Storia di chirurgia dei seni paranasali o dei turbinati nasali, e/o chirurgia elettiva maxillofacciale entro 6 mesi prima dell’inizio del trattamento pianificato (randomizzazione);
    Asma grave o storia di asma non controllato/parzialmente controllato entro 3 mesi prima dello screening (in base allo strumento di controllo GINA);
    Storia di rinosinusite cronica
    E.5 End points
    E.5.1Primary end point(s)
    Average daily total Combined Symptom-Medication score (CSMS) based on an equal weight of the dSS and of the dMS for the 14 days of highest pollen load within the peaks of the grass pollen season taking into account:
    • Daily rhinoconjunctivitis total Symptom Score (dSS) of the six rhinoconjunctivitis symptoms over the previous 24 hours, which include itching, sneezing, rhinorrhea, obstruction, ocular itching/grittiness/redness and ocular tearing with scale from 0-3 per symptom (maximum score 18 points / divided by 6 symptoms = 3 points)
    and
    • Daily Medication Score (dMS) over the previous 24 hours. If more than 1 class of rescue medication is used on a particular day, the highest score will be retained for the dMS of that day (maximum score = 3)
    Media del Combined Symptom-Medication score (CSMS) totale quotidiano basato su un eguale peso del dSS e del dMS per i 14 giorni di maggior carico di polline entro i picchi della stagione pollinica delle graminacee, prendendo in considerazione:
    • Daily rhinoconjunctivitis total Symptom Score (dSS) dei sei sintomi per la rinocongiuntivite nelle precedenti 24 ore, che includono prurito, starnutazione, rinorrea, ostruzione, prurito oculare/granulosità/rossore e lacrimazione oculare con scala da 0-3 per sintomo (Massimo score 18 punti/divisi per 6 sintomi = 3 punti)
    e
    • Daily Medication Score (dMS) nelle precedenti 24 ore. Se è stata usata più di 1 classe di terapia di supporto in un particolare giorno, il punteggio più alto sarà mantenuto per il dMS di quel giorno (punteggio Massimo = 3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days of highest pollen load within the peaks of the grass pollen season
    14 giorni di maggior carico di polline entro i picchi della stagione pollinica delle graminacee
    E.5.2Secondary end point(s)
    Average Combined Symptom-Medication score (CSMS); average Daily rhinoconjunctivitis total Symptom Score (dSS); Average Daily Medication Score (dMS); The “well days”, being defined as days of the entire grass pollen season with a maximum ARC symptom score of 2 and no rescue medication use (verum vs placebo); Excellence of rhinoconjunctivitis control during the entire grass pollen season = more than 50% well days in the grass pollen season;; Visual analogue scale (VAS) score, using a 100-mm scale; A global evaluation carried out by the patient for the entire grass pollen season, to evaluate the Treatment Satisfaction (verum vs placebo); A global evaluation carried out by the patient in the overall comparison of the current grass pollen season versus the previous season (previous year); Safety of the treatment by means of physical examinations, blood and urine sampling, description of the adverse events (frequency, intensity, severity and duration of adverse events) and safety laboratory data following treatment with LAIS® Grass tablets .
    Combined Symptom-Medication score (CSMS) medio; Daily rhinoconjunctivitis total Symptom Score (dSS) medio:; Daily Medication Score (dMS) medio; I “well days”, definiti come giorni dell’intera stagione pollinica delle graminacee con un punteggio massimo dei sintomi di 2 e nessuna terapia di supporto utilizzata (verum vs placebo); eccellenza del controllo di rinocongiuntivite durante l’intera stagione pollinica = più del 50% di well days nella stagione pollinica; Punteggio della scala visuo-analogica (VAS), usando una scala 100-mm; Valutazione globale eseguita dal paziente per l’intera stagione pollinica, per valutare la Soddisfazione al Trattamento (verum vs placebo); Valutazione globale eseguita dal paziente in una comparazione complessiva della corrente stagione pollinica delle graminacee rispetto alla stagione precedente (anno antecedente); Sicurezza del trattamento tramite esame fisico, prelievi di sangue e urine, descrizione degli eventi avversi ( frequenza, intensità, gravità e durata degli eventi avversi) e dei dati di sicurezza di laboratorio dopo il trattamento con le compresse LAIS® Grass
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) during the days with = 50 pollen/m3, b) the entire grass pollen season until the study end (verum vs placebo);; a) for the 14-days of highest pollen load in the peak grass pollen season, b) during the days with = 50 pollen/m3, c) over the entire grass pollen season until the study end (verum vs placebo); a) for the 14-days of highest pollen load in the peak grass pollen season, b) during the days with = 50 pollen/m3, c) over the entire grass pollen season until the study end (verum vs placebo); entire grass pollen season; entire study duration; entire grass pollen season; at the end of study; total study duration
    a) durante i giorni con = 50 pollini/m3,
    b) l’intera stagione pollinica delle graminacee fino alla fine dello studio (verum vs placebo);; a) per i 14 giorni di massimo carico di polline nel picco stagionale pollinico di graminacee,
    b) durante i giorni con = 50 pollini/m3
    c) durante l’intera stagione pollinica delle graminacee fino alla fine dello studio (verum vs placebo);; a) per i 14 giorni di massimo carico di polline nel picco stagionale pollinico di graminacee,
    b) durante i giorni con = 50 pollini/m3
    c) durante l’intera stagione pollinica delle graminacee fino alla fine dello studio (verum vs placebo);; intera stagione pollinica delle graminacee; intera durata dello studio; intera stagione pollinica; fine dello studio; durante l'intero studio
    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 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 concerned20
    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 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 months9
    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 months9
    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 Yes
    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: 88
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 176
    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 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 state264
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    F.4.2.2In the whole clinical trial 264
    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)
    the subject, at the end of study, will be followed according to the normal clinical practice
    i pazienti al termine della sperimentazione saranno seguiti da normale pratica clinica
    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 Decision2019-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
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