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
• Sponsor: Menarini International Operations Luxembourg SA
• Information provided by (Responsible Party): Menarini International Operations Luxembourg SA

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Conditions: Allergic Rhinitis; Urticaria
• Interventions: Drug: Bilastine; Drug: Placebo
• Enrollment: 19

Participant Flow

Recruitment Details
Pre-assignment Details	Screening was performed in 2 separate sections, at hospital site (H) and at the simulator (S) center. A total of 19 patients were screened and only one discontinued study before starting placebo treatment due to agitation, sickness, transpiration and vomiting at the simulator driving test.

Arm/Group Title	Placebo (run-in); Bilastine
Arm/Group Description	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: Bilastine tablets once a day for 7+3 days Placebo: Placebo tablets once a day during 7+3 days run in period
Period Title: Placebo (run-in)
Started	18
Completed	18
Not Completed	0
Period Title: Bilastine (Active Treatement)
Started	18
Completed	18
Not Completed	0

Baseline Characteristics

Arm/Group Title		Placebo (run-in); Bilastine
Arm/Group Description		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: Bilastine tablets once a day for 7+3 days Placebo: Placebo tablets once a day during 7+3 days run in period
Overall Number of Baseline Participants		18
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	18 participants
		38.4 (7.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	Female	8 44.4%
	Male	10 55.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	Hispanic or Latino	18 100.0%
	Not Hispanic or Latino	0 0.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	18 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Italy	Number Analyzed	18 participants
		18

Outcome Measures

1. Primary Outcome

Title	Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test
Description	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.
Time Frame	7+3 days of active treatment

Outcome Measure Data

Analysis Population Description

The study included adult outpatient of either sex affected by allergic rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).

Arm/Group Title	Bilastine
Arm/Group Description:	Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
Overall Number of Participants Analyzed	18
Mean (Standard Deviation); Unit of Measure: meters
	-0.041 (0.047)

2. Secondary Outcome

Title	Maintenance of Constant Speed Evaluated During the F1 Simulator
Description	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 Frame	7±3 days of active treatment

Outcome Measure Data

Analysis Population Description

The study included adult outpatient of either sex,affected by Allergic Rhinitis (seasonal or perennial) and/or Chronic Urticaria (induced or not induced),able to perform a preliminary driving test on F1-high speed simulator without experiencing signs or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness, etc).

Arm/Group Title	Bilastine
Arm/Group Description:	Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
Overall Number of Participants Analyzed	18
Mean (Standard Deviation); Unit of Measure: Km/h
	-1.397 (2.991)

3. Secondary Outcome

Title	Time to Reaction Evaluated During the F1 Simulator
Description	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.
Time Frame	7±3 days of active treatment

Outcome Measure Data

Analysis Population Description

Adult outpatient of eighter sex affected by Allergic Rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).

Arm/Group Title	Bilastine
Arm/Group Description:	Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
Overall Number of Participants Analyzed	18
Mean (Standard Deviation); Unit of Measure: msec
Time reaction to Button A	-34.5 (95.71)
Time reaction to button B	-18.25 (66.28)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo (run-in); Bilastine
Arm/Group Description	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: Bilastine tablets once a day for 7+3 days Placebo: Placebo tablets once a day during 7+3 days run in period
All-Cause Mortality
	Placebo (run-in); Bilastine
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Placebo (run-in); Bilastine
	Affected / at Risk (%)	# Events
Total	0/18 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo (run-in); Bilastine
	Affected / at Risk (%)	# Events
Total	18/18 (100.00%)
Cardiac disorders
bradycardia † 1	1/18 (5.56%)	1
Investigations
Laboratory test abnormal † 1	17/18 (94.44%)	34
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 18.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The PI can disclose the results after sending to the Sponsor, for appropriate knowledge and / or possible review, copy of the document, at least 90 days prior to publication and / or presentation. If requested in writing by the Sponsor, the PI will agree to make changes to the manuscript and / or deferred publication of the manuscript further 90 days to allow the patent application.

Results Point of Contact

• Name/Title: Patrizia Pepe, MD
• Organization: Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena
• Phone: +39. 059 4225449

• Responsible Party: Menarini International Operations Luxembourg SA
• ClinicalTrials.gov Identifier: NCT02576041
• Other Study ID Numbers: MEIN/14/Bil-ARU/001; 2015-001313-26 ( EudraCT Number )
• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Results First Submitted: September 22, 2016
• Results First Posted: January 16, 2017
• Last Update Posted: April 18, 2017