Rhinitis, Cognition and Driving Performance

Not Applicable

Completed

• Conditions: Driving Ability; Cognition; Seasonal Allergic Rhinitis
• Interventions: Drug: cetirizine 10 mg; Drug: fluticasone furoate; Drug: placebo

• Registration Number: NCT01318681
• Lead Sponsor: Maastricht University Medical Center

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-03
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2012-03
• Study Completion: 2012-10
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pollen provocation with systemic treatment	cetirizine 10 mg	Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution
Pollen provocation with topical treatment	fluticasone furoate	treatment with 25ug fluticasone furoate after a nasal pollen challenge
placebo treatment after pollen challenge	placebo	Placebo treatment after a nasal challenge with pollen solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands