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Seasonal Allergic Rhinitis and Driving Ability

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ClinicalTrials.gov Identifier: NCT00223587
Recruitment Status : Terminated (slow recruitment rate)
First Posted : September 22, 2005
Last Update Posted : April 15, 2008
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
Utrecht Institute for Pharmaceutical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Other: 1 week of treatment discontinuation Phase 4

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  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever Memory
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation] [ Time Frame: allergic season and winter ]


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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

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

Responsible Party: Joris C Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT00223587     History of Changes
Other Study ID Numbers: 04/089-E
First Posted: September 22, 2005    Key Record Dates
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