Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria (F1)
|ClinicalTrials.gov Identifier: NCT02576041|
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : January 16, 2017
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Urticaria||Drug: Bilastine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Placebo (run-in); Bilastine
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).
Bilastine tablets once a day for 7+3 days
Other Name: Robilas
Placebo tablets once a day during 7+3 days run in period
- Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test [ Time Frame: 7+3 days of active treatment ]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.
- Maintenance of Constant Speed Evaluated During the F1 Simulator [ Time Frame: 7±3 days of active treatment ]Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.
- Time to Reaction Evaluated During the F1 Simulator [ Time Frame: 7±3 days of active treatment ]During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576041
|Azienda Ospedaliero-Universitaria Policlinico|
|Principal Investigator:||Patrizia Pepe||Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena|