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Completed

NCT Number: NCT01318681

Rhinitis, Cognition and Driving Performance

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)

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Key information

Conditions

Seasonal Allergic Rhinitis Cognition Driving Ability Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 62ooMD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetirizine 10 mg

Drug

cetirizine 10 mg over encapsulated

Fluticasone Furoate

Drug

nasal spray 25ug per dose

Placebo

Drug

a placebo nasal spray and placebo capsule are available for double dummy treatment

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP) in highway driving

    Time frame: 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 outcomes

  1. Word Learning Test (WLT-15) verbal memory score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 18, 2011
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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