Rhinitis, Cognition and Driving Performance

NCT01318681 | Completed

• 1 other identifier: EPU-055
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Seasonal Allergic Rhinitis; Driving Ability; Cognition

Keywords

driving, memory, cognition

Outcome Measures

Primary Outcomes (1)

• Standard Deviation of Lateral Position (SDLP) in highway driving

  Standard Deviation of Lateral Position (SDLP) is the amount of "weaving" that occurs when a person is driving in a straight line on the highway and instructed to maintain a steady speed and position within the lane he/she is driving

  2:00 - 3:00 hrs post dosing

Secondary Outcomes (1)

• Word Learning Test (WLT-15) verbal memory score

  2:30 hrs post dosing

Study Arms (4)

Pollen provocation with systemic treatment

EXPERIMENTAL

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

Drug: cetirizine 10 mg

Pollen provocation with topical treatment

EXPERIMENTAL

treatment with 25ug fluticasone furoate after a nasal pollen challenge

Drug: fluticasone furoate

placebo treatment after pollen challenge

PLACEBO COMPARATOR

Placebo treatment after a nasal challenge with pollen solution

Drug: placebo

control condition

NO INTERVENTION

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

Interventions

cetirizine 10 mg DRUG

cetirizine 10 mg over encapsulated

Pollen provocation with systemic treatment

fluticasone furoate DRUG

nasal spray 25ug per dose

Pollen provocation with topical treatment

placebo DRUG

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

placebo treatment after pollen challenge

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers known with Seasonal Allergic Rhinitis
• Experienced drivers holding a license
• years of age

You may not qualify if:

• Asthma or other chronic illness
• current psychoactive medication
• History of drug abuse

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 62ooMD, Netherlands

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Cetirizine; fluticasone furoate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR Eric Vuurman

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 8, 2013

Record last verified: 2011-03

Locations

NL (1)