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Rhinitis, Cognition and Driving Performance

NCT ID: NCT01318681

Last Updated: 2013-11-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-10-31

Brief Summary

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This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis Driving Ability Cognition

Keywords

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driving, memory, cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pollen provocation with systemic treatment

Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution

Group Type EXPERIMENTAL

cetirizine 10 mg

Intervention Type DRUG

cetirizine 10 mg over encapsulated

Pollen provocation with topical treatment

treatment with 25ug fluticasone furoate after a nasal pollen challenge

Group Type EXPERIMENTAL

fluticasone furoate

Intervention Type DRUG

nasal spray 25ug per dose

placebo treatment after pollen challenge

Placebo treatment after a nasal challenge with pollen solution

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

a placebo nasal spray and placebo capsule are available for double dummy treatment

control condition

A placebo drug is administered after a sham nasal challenge with a pollen solution

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cetirizine 10 mg

cetirizine 10 mg over encapsulated

Intervention Type DRUG

fluticasone furoate

nasal spray 25ug per dose

Intervention Type DRUG

placebo

a placebo nasal spray and placebo capsule are available for double dummy treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers known with Seasonal Allergic Rhinitis
* Experienced drivers holding a license
* 21- 45 years of age

Exclusion Criteria

* Asthma or other chronic illness
* current psychoactive medication
* History of drug abuse
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Vuurman

DR Eric Vuurman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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EPU-055

Identifier Type: -

Identifier Source: org_study_id

NCT01239264

Identifier Type: -

Identifier Source: nct_alias