Seasonal Allergic Rhinitis and Driving Ability

This study has been terminated.
(slow recruitment rate)
Sponsor:
Collaborator:
UCB Pharma
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharma
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
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014