Rhinitis, Cognition and Driving Performance

Study Overview
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Brief Summary
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This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)

Official Title
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Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance

Conditions
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Seasonal Allergic Rhinitis, Driving Ability, Cognition

Intervention / Treatment
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* Drug: cetirizine 10 mg
* Drug: fluticasone furoate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers known with Seasonal Allergic Rhinitis Experienced drivers holding a license 21- 45 years of age Exclusion Criteria: Asthma or other chronic illness current psychoactive medication History of drug abuse

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pollen provocation with systemic treatment<br>Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution | Drug: cetirizine 10 mg<br>* cetirizine 10 mg over encapsulated<br>|
| Experimental: Pollen provocation with topical treatment<br>treatment with 25ug fluticasone furoate after a nasal pollen challenge | Drug: fluticasone furoate<br>* nasal spray 25ug per dose<br>|
| Placebo Comparator: placebo treatment after pollen challenge<br>Placebo treatment after a nasal challenge with pollen solution | Drug: placebo<br>* a placebo nasal spray and placebo capsule are available for double dummy treatment<br>|
| No Intervention: control condition<br>A placebo drug is administered after a sham nasal challenge with a pollen solution | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation of Lateral Position (SDLP) in highway driving | Standard Deviation of Lateral Position (SDLP) is the amount of weaving that occurs when a person is driving in a straight line on the highway and instructed to maintain a steady speed and position within the lane he/she is driving | 2:00 - 3:00 hrs post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word Learning Test (WLT-15) verbal memory score | Subjects are presented with a list of 15 words at a rate of one word/second with a pause between words of one second. Immediately following the presentation subjects are asked to recall and name as many words as possible. The total number of words recalled after three repeated presentations of the same list of words is the outcome variable | 2:30 hrs post dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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driving, memory, cognition