Seasonal Allergic Rhinitis and Driving Ability - Full Text View

Purpose

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).

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Other: 1 week of treatment discontinuation	Phase IV

MedlinePlus related topics:

Hay Fever Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation] [ Time Frame: allergic season and winter ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	September 2004
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 1 week of treatment discontinuation	Other: 1 week of treatment discontinuation 1 week of treatment discontinuation during allergic rhinitis season

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.

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223587

Locations


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

Sponsors and Collaborators

Utrecht Institute for Pharmaceutical Sciences

UCB

Investigators


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

Principal Investigator:	Joris Verster, PhD	Utrecht Institute for Pharmaceutical Sciences

More Information

Responsible Party:	Utrecht University ( Joris C Verster )
Study ID Numbers:	04/089-E
First Received:	September 13, 2005
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00223587
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:

driving

memory

Study placed in the following topic categories:

Hypersensitivity

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate

Rhinitis

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Nose Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Utrecht Institute for Pharmaceutical Sciences UCB
Information provided by:	Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00223587