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    Summary
    EudraCT Number:2015-001313-26
    Sponsor's Protocol Code Number:MEIN/14/Bil-ARU/001
    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:2016-07-20
    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 number2015-001313-26
    A.3Full title of the trial
    Effects of Bilastine on F1 Simulator driving performance in patients affected by allergic rhinitis and/or urticaria
    Effetti della Bilastina sulla capacità di guida al simulatore di Formula 1 in pazienti con rinite allergica e/o orticaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Bilastine on driving performance in patients affected by allergic rhinitis and/or urticaria
    Effetti del farmaco bilastina sulle prestazioni alla guida di pazienti affetti da rinite allergica e/o orticaria
    A.3.2Name or abbreviated title of the trial where available
    F1
    F1
    A.4.1Sponsor's protocol code numberMEIN/14/Bil-ARU/001
    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 SponsorMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
    B.1.3.4CountryLuxembourg
    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 supportAzienda Farmaceutica: Menarini International Operations Luxembourg - Lussemburgo
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLB Research
    B.5.2Functional name of contact pointDipartimento Ricerca clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Lombardia n° 81
    B.5.3.2Town/ cityCantù
    B.5.3.3Post code22063
    B.5.3.4CountryItaly
    B.5.4Telephone number+39/031734908
    B.5.5Fax number+39/0317372218
    B.5.6E-mailflavia.baruzzi@lbresearch.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 Yes
    D.2.1.1.1Trade name ROBILAS - 20 MG COMPRESSE 20 COMPRESSE IN BLISTER AL/AL
    D.2.1.1.2Name of the Marketing Authorisation holderMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
    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 nameROBILAS
    D.3.2Product code ROBILAS
    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.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 placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    allergic rhinitis (seasonal or perennial) and/or urticaria
    rinite allergica (stagionale o perenne) e/o orticaria
    E.1.1.1Medical condition in easily understood language
    allergic rhinitis (seasonal or perennial) and/or urticaria
    rinite allergica (stagionale o perenne) e/o orticaria
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039095
    E.1.2Term Rhinitis seasonal
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10039094
    E.1.2Term Rhinitis perennial
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10009159
    E.1.2Term Chronic urticaria
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the attention level (wakefulness) by assessing the patients’ driving performance (driving ability in stress condition) using the F1 high-speed simulator, following treatment with Bilastine;
    • To assess the reactivity level by assessing the patients’ psychomotor reactivity during the driving performance test (using the F1-high speed simulator), following treatment with Bilastine.
    • Valutare il livello di attenzione (vigilanza) determinando la performance di guida (abilità alla guida in condizione di stress), mediante un simulatore di F1 ad alta velocità, successivamente al trattamento con bilastina;
    • Valutare il livello di reattività determinando la reattività psicomotoria durante il test di guida (mediante il simulatore di F1 ad alta velocità), successivamente al trattamento con Bilastina.
    E.2.2Secondary objectives of the trial
    Not Applicable
    Non Applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients affected by allergic rhinitis (seasonal or perennial) or urticaria (induced and not induced) who need histamine H1-receptor antagonist therapy according to PI therapeutic decision;
    • Males and females aged between 21 and 55 years;
    • Subjects having a valid driving license from more than 3 years;
    • Subjects having a driving experience of at least 5000 km per year;
    • Potential compliant subjects will be enrolled only if they tolerate driving the F1-simulator (starting from V-1 S).
    • Pazienti affetti da rinite allergica (stagionale o perenne) o orticaria (indotta e non indotta) che necessitino di terapia con farmaci H1-antagonisti, secondo giudizio del PI;
    • Maschi e femmine di età compresa tra 21 e 55 anni;
    • Soggetti con patente di guida valida da più di 3 anni;
    • Soggetti con esperienza di guida di almeno 5000 km all’anno;
    • I soggetti potenzialmente complianti saranno arruolati solo se sono in grado di tollerare la prova al simulatore di F1 (a V-1 S).
    E.4Principal exclusion criteria
    • Subjects with autoimmune urticaria;
    • Hypersensitivity to the active substance bilastine or to any of the excipients;
    • History or symptoms of severe mental or physical disorders or taking substance and alcohol;
    • Excessive smoking (more than 20 cigarettes per day), or consumption of caffeinated beverages (more than 6 cups per day);
    • Subjects who need unimpaired psychophysical condition due to their job;
    • Subjects with any non corrected visual defect or locomotor disorder which could interfere with the study;
    • Subjects ineligible at Visit V-1;
    • Subjects with known allergic reactions to antihistamines;
    • Subjects with porfiria;
    • Subjects with important sleep disturbances or kinetosis;
    • Subjects with clinically important (based on Investigator’s judgment) renal or hepatic impairment, or gastrointestinal diseases (e.g. malabsorption);
    • Subjects with a medical history of seizure (i.e. epileptic related) or with current seizure;
    • Presence of significant medical condition/concomitant illnesses that, in the opinion of the Investigator, renders the patient immunocompromised or not suitable for a clinical trial or could adversely affect the subject’s participation or evaluation in this study;
    • Subjects for whom, in the opinion of the Investigator, there is concern about compliance with the study procedures;
    • Presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract);
    • Presence of active cancer which requires chemotherapy or radiation therapy;
    • Presence of alcohol abuse or drug addiction;
    • Pregnancy or breast-feeding;
    • Treatment with: diuretics, corticosteroids (other than medication applied topically), central nervous system medications or medications with sedative effects (sleep inducing or antidepressant, sedative medications), medications that can interact with bilastine, other medications. In particular, patients treated with any of the following drugs will be excluded:
    - Imipramine antidepressants, anticholinergic antiparkinsonians, atropine antispasmodics, disopyramide, phenothiazine neuroleptics;
    - Sedative antidepressants, monoamine oxidase (MAOI) inhibitors, barbiturates, benzodiazepines, clonidine and related substances, hypnotics, morphine derivatives (analgesics, antitussives, replacement treatments), neuroleptics, anxiolytics;
    - Treatments with P-glycoprotein inhibitors (e.g. ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem), which may increase the plasmatic levels of bilastine;
    - Treatments that are substrates or inhibitors of OATP1A2 (e.g. ritonavir, rifampicin), which may decrease plasma concentrations of bilastine
    - Other treatments that can interact with bilastine (e.g. ketoconazole, erythromycin, diltiazem);
    Treatment with anticoagulants (e.g. warfarin);
    - Sedatives, hypnotics, tranquillizers or any other addictive agents;
    - Other treatments not admitted during the study: betahistine, anticholinesterases, arrhythmogenic drugs;
    - H2-antihistamines;
    - H1 antihistamines other than study medication or rescue medication.
    • Soggetti con orticaria autoimmune;
    • Ipersensitività al principio attivo bilastina o a uno qualsiasi dei suoi eccipienti;
    • Anamnesi o sintomi di patologie gravi mentali o fisiche o soggetti che assumano droghe o alcool;
    • Consumo eccessivo di fumo (più di 20 sigarette al giorno), o di bevande a base di caffeina (più di 6 tazze al giorno);
    • Soggetti che necessitano di condizioni psicopatologiche non compromesse a causa del loro lavoro;
    • Soggetti con difetti visivi non corretti o problemi locomotori che potrebbero interferire con lo studio;
    • Soggetti ineleggibili alla Visita -1;
    • Soggetti con reazioni allergiche note agli antiistaminici;
    • Soggetti con porfiria;
    • Soggetti con disturbi del sonno importanti o con chinetosi;
    • Soggetti con insufficienza epatica o renale clinicamente importante (a giudizio dello Sperimentatore) o patologie gastrointestinali (per es. malassorbimento);
    • Soggetti con anamnesi di convulsioni (i.e. correlate ad epilessia) o con crisi in corso;
    • Presenza di condizioni mediche significative/patologie concomitanti che, a giudizio dello Sperimentatore, potrebbe rendere il paziente immunocompromesso o non adatto ad uno studio clinico o che potrebbero influire negativamente sulla partecipazione del soggetto o sulla sua valutazione nello studio;
    • Soggetti per cui, a giudizio dello Sperimentatore, potrebbe essere dubbia la compliance alle procedure dello studio;
    • Presenza di condizioni gastrointestinali permanenti che potrebbero influenzare la terapia orale (diarrea cronica, malformazioni congenite o mutilazioni chirurgiche del tratto gastrointestinale);
    • Presenza di tumore in fase attiva che richieda chemioterapia o radioterapia;
    • Abuso di alcool o dipendenza da droga;
    • Gravidanza o allattamento;
    • Trattamento con: diuretici, corticosteroidi (con l’eccezione di terapie topiche), farmaci che agiscono sul sistema nervoso centrale, o farmaci con effetto sedativo (farmaci contro l’insonnia, sedativi), farmaci che possano interagire con bilastina, altri farmaci. In particolare, verranno esclusi i pazienti in trattamento con i seguenti farmaci:
    - Antidepressivi tipo imipramina, anticolinergici per il morbo di Parkinson, antispasmodici atropinici, disopiramide, neurolettici fenotiazinici;
    - Antidepressivi sedativi, inibitori delle monoaminoossidasi (MAOI), barbiturici, benzodiazepine, clonidina e sostanze correlate, ipnotici, derivati della morfina (analgesici, antitussivi, trattamenti sostitutivi), neurolettici, ansiolitici;
    - Trattamenti con inibitori della glicoproteina P (per es. ketoconazolo, eritromicina, ciclosporina, ritonavir, diltiazem), che possono aumentare i livelli plasmatici di bilastina;
    - Trattamenti con sostanze che sono substrato o inibitori di OATP1A2 (per es. ritonavir, rifampicina), che potrebbero diminuire le concentrazioni plasmatiche di bilastina;
    - Altri trattamenti che potrebbero interagire con bilastina (per es. ketoconazolo, eritromicina, diltiazem);
    - Trattamenti con anticoagulanti (per. es. warfarin);
    - Sedativi, ipnotici, tranquillanti o altre sostanze che inducono dipendenza;
    - Altri trattamenti non consentiti durante lo studio: betaistina, anticolinoesterasi farmaci aritmogeni;
    - H2-antagonisti;
    - H1 antagonisti diversi dal farmaco in studio o farmaci al bisogno.
    E.5 End points
    E.5.1Primary end point(s)
    Parameter 1. Standard Deviation Lateral Position – SDLP The vehicle position will be analyzed and a synthesis value, representing the mean deviation value from central position, will be confirmed. The F1-simulator will record the vehicle position at pre-specified time intervals during the performance (sample recording every 0.1 seconds). Data will be automatically analyzed and mean square deviation from central position will summarize the stable parameter of quality in keeping the requested path.
    •Parametro 1. Deviazione Standard della Posizione Laterale – SDLP Sarà analizzata la posizione del veicolo e verrà calcolato un valore di sintesi che rappresenta la deviazione dalla posizione centrale. Il simulatore di F1 registrerà la posizione del veicolo a intervalli di tempo pre-definiti durante la prova (registrazioni ogni 0.1 secondi). I dati saranno analizzati automaticamente e la deviazione quadratica media dalla posizione centrale riassumerà il parametro di qualità nel mantenere la traiettoria richiesta.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At V2, at the end of the period of 7 (+3 days) of treatment with bilastine
    a V2, al termine del periodo di trattamento di 7 8+3) giorni con bilastina
    E.5.2Secondary end point(s)
    •Parameter 2 – Maintenance of constant speed Changes from requested speed will be recorded and reported by the F1-high speed simulator. A summary value will be provided to resume the mean deviation from the requested speed. The F1-simulator will record vehicle speed at pre-specified time intervals during the performance (sample recording every 0.1 seconds). Data will be automatically analyzed and the mean square deviation will summarize the stable parameter of keeping the requested speed. Parameter 3 - Delay in changing gear Delay in changing gear when requested (led enlighten on the dashboard) will give information on driver’s reactivity level during the test and exercises. The synthesis value reported by the F1-high speed simulator will summarize the mean reactivity level of the patient during the test •Parameter 4 - Time to reaction Delay in handling on the steering wheel at request (when led enlighten on the dashboard) will give information on the reactivity level during test. The mean delay value will summarize the subjects’ alert grade during the test.
    Parametro 2 – Mantenimento della velocità costante Saranno registrati e riportati dal simulatore di F1 gli scostamenti dalla velocità richiesta. Sarà fornito un valore che riassumerà la deviazione media dalla velocità richiesta. Il simulatore di F1 registrerà la velocità del veicolo a intervalli di tempo pre-definiti durante la prova (registrazione ogni 0.1 secondi). I dati saranno analizzati automaticamente e la deviazione quadratica media riassumerà il parametro relativo al mantenimento della velocità richiesta.Parametro 3 – Ritardo nel cambiare marcia Il ritardo nel cambiare marcia, quando richiesto, (led illuminato sul cruscotto) fornisce informazioni sul livello di reattività del guidatore durante la prova. Il valore di sintesi riportato dal simulatore di F1 ad alta velocità riassumerà il livello medio di reattività del paziente durante il test. •Parametro 4 - Tempo di reazione Il ritardo nella manipolazione del volante quando richiesto (led illuminato sul cruscotto) fornirà informazioni sul livello di reattività durante il test. Il valore medio del ritardo riassumerà il grado di allerta del soggetto durante il test
    E.5.2.1Timepoint(s) of evaluation of this end point
    At V2, at the end of the period of 7 (+3) days of treatment with bilastine.
    A V2, al termine del periodo di trattamento di 7 (+3) giorni con bilastina
    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 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 Yes
    E.6.13.1Other scope of the trial description
    To evaluate the effects of bilastine on driving performance (attention and reactivity levels) of patients
    Valutare gli effetti di bilastina sulla performance di guida dei pazienti (attenzione e reattività)
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospettico, a singolo braccio di trattamento, non controllato, in aperto.
    prospective, single treatment arm,uncontrolled, open-label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 18
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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)
    In case of any AE ongoing at the end of the study the Investigator is expected to follow-up until the outcome of the AE has been ascertained (recovered or chronicised)
    In caso di eventi avversi in corso al termine dello studio lo Sperimentatore effettuerà un follow-up fino a determinazione dell'esito (risoluzione o stabilizzazione)
    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 Decision2015-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-21
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