Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
Condition: Allergic Rhinitis; Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria
Intervention: Bilastine; Placebo
Intervention description: Bilastine tablets once a day for 7+3 days; Placebo tablets once a day during 7+3 days run in period
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: driving simulator

Summary:

      The aim of the study is to evaluate the effects of Bilastine on patients' attention and
      reactivity levels by measuring psychophysical performance at a F1-high speed simulator
      driving test.
    

Eligibility criteria:

        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;

          -  Body Mass Index (BMI) between 19 and 30 kg/m2 (included);

          -  If women: negative pregnant test and contraception from at least 30 days before the
             study (Visit V-1) and up to the end of the study. For women patients the negative
             pregnant test will be acquired before the Simulator performance (Visit V-1H);

          -  Subjects having a valid driving license from more than 3 years;

          -  Subjects having a driving experience of at least 5000 km per year;

          -  Subjects able to understand the protocol and to come to the visits;

          -  Subjects able to give a written informed consent;

          -  Subjects who, at investigator's judgment, are likely to be compliant during the study
             and do not use potentially adulterating drugs;

          -  Potential compliant subjects will be enrolled only if they tolerate driving the
             F1-simulator (starting from V-1 S).

        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 porphyria;

          -  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. In any case,
                  the possibility of inclusion of patients taking any of these drugs will be left
                  at the Investigator's judgment.