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CompletedNCT01318681Updated Nov 8, 2013

Rhinitis, Cognition and Driving Performance

An interventional study of cetirizine 10 mg and fluticasone furoate in Seasonal Allergic Rhinitis, Driving Ability and Cognition, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by Maastricht University Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Seasonal Allergic Rhinitis
  • Driving Ability
  • Cognition

Keywords

  • driving, memory, cognition
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 22 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers known with Seasonal Allergic Rhinitis
  • Experienced drivers holding a license
  • 21- 45 years of age

Exclusion criteria

Exclusion Criteria:

  • Asthma or other chronic illness
  • current psychoactive medication
  • History of drug abuse
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Pollen provocation with systemic treatment

    Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution

    Drug: cetirizine 10 mg

  • Experimental
    Pollen provocation with topical treatment

    treatment with 25ug fluticasone furoate after a nasal pollen challenge

    Drug: fluticasone furoate

  • Placebo comparator
    placebo treatment after pollen challenge

    Placebo treatment after a nasal challenge with pollen solution

    Drug: placebo

  • No intervention
    control condition

    A placebo drug is administered after a sham nasal challenge with a pollen solution

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2:00 - 3:00 hrs post dosing

Secondary outcomes

  1. 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

    Time frame: 2:30 hrs post dosing

07

Study locations

1 site
  • Maastricht University
    Maastricht, Limburg 62ooMD, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01318681
Lead sponsor
Maastricht University Medical Center
Responsible party
Vuurman (DR Eric Vuurman, Maastricht University Medical Center) — Principal investigator
First posted
Mar 18, 2011
Start date
Jan 2011
Primary completion
Mar 2012
Completion
Oct 2012
Last update
Nov 8, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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