Seasonal Allergic Rhinitis and Driving Ability

April 11, 2008 updated by: Utrecht Institute for Pharmaceutical Sciences

Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning

On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study was set-up to examine whether untreated seasonal allergic rhinitis has an effect on driving ability. In addition to the driving tests, patients perform a memory test in the laboratory.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

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
      • Utrecht, Netherlands, 3508TB
        • Utrecht Institute for Pharmaceutical Sciences

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatients with seasonal allergic rhinitis
  • a valid driver's licence
  • written informed consent
  • a T5SS score >8 during the allergic season and <3 in winter

Exclusion Criteria:

  • use of medication or medical conditions that are known to affect driving ability
  • associated ENT disease or asthma

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
1 week of treatment discontinuation
Other: 1 week of treatment discontinuation
1 week of treatment discontinuation during allergic rhinitis season

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation]
Time Frame: allergic season and winter
allergic season and winter

Secondary Outcome Measures

Outcome Measure
Time Frame
Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation]
Time Frame: allergic season and winter
allergic season and winter
Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation]
Time Frame: allergic season and winter
allergic season and winter

Collaborators and Investigators

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

Sponsor

Utrecht Institute for Pharmaceutical Sciences

Collaborators

UCB Pharma

Investigators

  • Study Director: Edmund Volkerts, PhD, Utrecht Institute for Pharmaceutical Sciences

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

September 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 11, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/089-E

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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