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Seasonal Allergic Rhinitis and Driving Ability

This study has been terminated.
(slow recruitment rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223587
First Posted: September 22, 2005
Last Update Posted: April 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UCB Pharma
Information provided by:
Utrecht Institute for Pharmaceutical Sciences
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation] [ Time Frame: allergic season and winter ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Joris C Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT00223587     History of Changes
Other Study ID Numbers: 04/089-E
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
driving
memory

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