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Seasonal Allergic Rhinitis and Driving Ability

Primary Purpose

Seasonal Allergic Rhinitis

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
1 week of treatment discontinuation
Sponsored by
Utrecht Institute for Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Allergic Rhinitis focused on measuring driving, memory

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Utrecht Institute for Pharmaceutical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

1 week of treatment discontinuation

Outcomes

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]

Secondary Outcome Measures

Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation]
Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation]

Full Information

First Posted
September 13, 2005
Last Updated
April 11, 2008
Sponsor
Utrecht Institute for Pharmaceutical Sciences
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00223587
Brief Title
Seasonal Allergic Rhinitis and Driving Ability
Official Title
Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment rate
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Utrecht Institute for Pharmaceutical Sciences
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
driving, memory

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
1 week of treatment discontinuation
Intervention Type
Other
Intervention Name(s)
1 week of treatment discontinuation
Intervention Description
1 week of treatment discontinuation during allergic rhinitis season
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation]
Time Frame
allergic season and winter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund Volkerts, PhD
Organizational Affiliation
Utrecht Institute for Pharmaceutical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joris Verster, PhD
Organizational Affiliation
Utrecht Institute for Pharmaceutical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utrecht Institute for Pharmaceutical Sciences
City
Utrecht
ZIP/Postal Code
3508TB
Country
Netherlands

12. IPD Sharing Statement

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Seasonal Allergic Rhinitis and Driving Ability

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