Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria

NCT02576041 | Completed Phase 4 Results

• 2 other identifiers: MEIN/14/Bil-ARU/0012015-001313-26
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis; Urticaria

Keywords

driving simulator

Outcome Measures

Primary Outcomes (1)

• Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test

  SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.

  7+3 days of active treatment

Secondary Outcomes (2)

• Maintenance of Constant Speed Evaluated During the F1 Simulator

  7±3 days of active treatment

• Time to Reaction Evaluated During the F1 Simulator

  7±3 days of active treatment

Study Arms (1)

Placebo (run-in); Bilastine

EXPERIMENTAL

At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).

Drug: Bilastine; Drug: Placebo

Interventions

Bilastine DRUG

Bilastine tablets once a day for 7+3 days

Also known as: Robilas

Placebo (run-in); Bilastine

Placebo DRUG

Placebo tablets once a day during 7+3 days run in period

Placebo (run-in); Bilastine

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• Menarini International Operations Luxembourg SA: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Policlinico

Modena, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Urticaria

Interventions

bilastine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Patrizia Pepe, MD
• Organization: Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena

+39. 059 4225449

Study Officials

• Patrizia Pepe

  Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 18, 2017
• Results First Posted: January 16, 2017

Record last verified: 2017-03

Locations

IT (1)