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NCT00223587 Clinical Trial

Seasonal Allergic Rhinitis and Driving Ability

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00223587
Other study ID # 04/089-E
Secondary ID
Status Terminated
Phase Phase 4
First received September 13, 2005
Last updated April 11, 2008
Start date September 2004
Est. completion date January 2008

Study information
Verified date April 2008
Source Utrecht Institute for Pharmaceutical Sciences
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date January 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• 1 week of treatment discontinuation
1 week of treatment discontinuation during allergic rhinitis season

Locations
Country Name City State
Netherlands Utrecht Institute for Pharmaceutical Sciences Utrecht

Sponsors (2)
Lead Sponsor Collaborator
Utrecht Institute for Pharmaceutical Sciences UCB Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation] allergic season and winter No
Secondary Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation] allergic season and winter No
Secondary Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation] allergic season and winter No
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