Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria (F1)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|