Effects of Bilastine on driving performance in patients affected by allergic rhinitis and/or urticaria

Phase 1

• Conditions: allergic rhinitis (seasonal or perennial) and/or urticaria; MedDRA version: 19.0 Level: LLT Classification code 10039095 Term: Rhinitis seasonal System Organ Class: 100000004870; MedDRA version: 19.0 Level: PT Classification code 10039094 Term: Rhinitis perennial System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0 Level: LLT Classification code 10009159 Term: Chronic urticaria System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-001313-26-IT
• Lead Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-12-21
• Study Start: 2016-07-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 18

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified