Trial Outcomes & Findings for Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria (NCT NCT02576041)

Last Updated: 2017-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

7+3 days of active treatment

Results posted on

2017-04-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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: Bilastine tablets once a day for 7+3 days Placebo: Placebo tablets once a day during 7+3 days run in period
Placebo (run-in) STARTED	18
Placebo (run-in) COMPLETED	18
Placebo (run-in) NOT COMPLETED	0
Bilastine (Active Treatement) STARTED	18
Bilastine (Active Treatement) COMPLETED	18
Bilastine (Active Treatement) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (run-in); Bilastine n=18 Participants 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
Age, Continuous	38.4 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 7+3 days of active treatment

Population: 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).

Outcome measures

Outcome measures
Measure	Bilastine n=18 Participants Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test	-0.041 meters Standard Deviation 0.047

SECONDARY outcome

Timeframe: 7±3 days of active treatment

Population: 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).

Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.

Outcome measures

Outcome measures
Measure	Bilastine n=18 Participants Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
Maintenance of Constant Speed Evaluated During the F1 Simulator	-1.397 Km/h Standard Deviation 2.991

SECONDARY outcome

Timeframe: 7±3 days of active treatment

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Bilastine n=18 Participants Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
Time to Reaction Evaluated During the F1 Simulator Time reaction to Button A	-34.5 msec Standard Deviation 95.71
Time to Reaction Evaluated During the F1 Simulator Time reaction to button B	-18.25 msec Standard Deviation 66.28

Adverse Events

Placebo (run-in); Bilastine

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo (run-in); Bilastine n=18 participants at risk 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
Cardiac disorders bradycardia	5.6% 1/18 • Number of events 1
Investigations Laboratory test abnormal	94.4% 17/18 • Number of events 34

Additional Information

Patrizia Pepe, MD

Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena

Phone: +39. 059 4225449

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER