Cognition, Driving Ability, Seasonal Allergic Rhinitis
Conditions
Keywords
driving, memory, cognition
Brief summary
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)
Interventions
DRUGcetirizine 10 mg
cetirizine 10 mg over encapsulated
DRUGfluticasone furoate
nasal spray 25ug per dose
DRUGplacebo
a placebo nasal spray and placebo capsule are available for double dummy treatment
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) in highway driving | 2:00 - 3:00 hrs post dosing | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Word Learning Test (WLT-15) verbal memory score | 2:30 hrs post dosing | 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 |
Countries
Netherlands
Outcome results
None listed