Rhinitis, Cognition and Driving Performance

November 7, 2013 updated by: Vuurman, Maastricht University Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 62ooMD
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
cetirizine 10 mg over encapsulated
EXPERIMENTAL: Pollen provocation with topical treatment
treatment with 25ug fluticasone furoate after a nasal pollen challenge
Drug: fluticasone furoate
nasal spray 25ug per dose
PLACEBO_COMPARATOR: placebo treatment after pollen challenge
Placebo treatment after a nasal challenge with pollen solution
Drug: placebo
a placebo nasal spray and placebo capsule are available for double dummy treatment
NO_INTERVENTION: control condition
A placebo drug is administered after a sham nasal challenge with a pollen solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2:00 - 3:00 hrs post dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2:30 hrs post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (ESTIMATE)

March 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPU-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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