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Seasonal Allergic Rhinitis and Driving Ability

NCT ID: NCT00223587

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Seasonal Allergic Rhinitis

Keywords

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driving memory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

1 week of treatment discontinuation

Group Type EXPERIMENTAL

1 week of treatment discontinuation

Intervention Type OTHER

1 week of treatment discontinuation during allergic rhinitis season

Interventions

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1 week of treatment discontinuation

1 week of treatment discontinuation during allergic rhinitis season

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

Utrecht Institute for Pharmaceutical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Utrecht University

Principal Investigators

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Edmund Volkerts, PhD

Role: STUDY_DIRECTOR

Utrecht Institute for Pharmaceutical Sciences

Joris Verster, PhD

Role: PRINCIPAL_INVESTIGATOR

Utrecht Institute for Pharmaceutical Sciences

Locations

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Utrecht Institute for Pharmaceutical Sciences

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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04/089-E

Identifier Type: -

Identifier Source: org_study_id