Seasonal Allergic Rhinitis and Driving Ability

This study has been terminated.
(slow recruitment rate)
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00223587
First received: September 13, 2005
Last updated: April 11, 2008
Last verified: April 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning

Resource links provided by NLM:


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
Experimental: A
1 week of treatment discontinuation
Other: 1 week of treatment discontinuation
1 week of treatment discontinuation during allergic rhinitis season
Other Name: 1 week of treatment discontinuation

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, Inc.
Investigators
Study Director: Edmund Volkerts, PhD Utrecht Institute for Pharmaceutical Sciences
Principal Investigator: Joris Verster, PhD Utrecht Institute for Pharmaceutical Sciences
  More Information

No publications provided

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

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
driving
memory

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014