NCT02576041

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Menarini International Operations Luxembourg SA · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a phase IV, interventional, prospective, mono-centric, single arm, uncontrolled, open label trial. The study included outpatient affected by Allergic Rhinitis and/or Chronic Urticaria, responding to inclusive criteria and able to perform a preliminary driving test on F1-high speed simulator (at the simulator centre) without experiencing signs or symptoms of intolerance towards the drive simulation (e.g., nausea, vomiting or dizziness etc). Each subject underwent 3 ambulatory visits at the hospital site and 3 driving test at the simulator centre.

Conditions

• Allergic Rhinitis
• Urticaria

Interventions

Type	Name	Description
DRUG	Bilastine	Bilastine tablets once a day for 7+3 days
DRUG	Placebo	Placebo tablets once a day during 7+3 days run in period

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-10-15
• Last updated: 2017-04-18
• Results posted: 2017-01-16

Locations

1 site across 1 country: Italy