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Rhinitis, Cognition and Driving Performance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01318681
First received: March 17, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 therefor 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)


Condition Intervention
Seasonal Allergic Rhinitis
Driving Ability
Cognition
 Drug: cetirizine 10 mg
Drug: fluticasonfuroaat
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever Memory
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Standard Deviation of Lateral Position (SDLP) in highway driving [ Time Frame: 2:00 - 3:00 hrs post dosing ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • WLT-15 verbal memory score [ Time Frame: 2:30 hrs post dosing ] [ Designated as safety issue: No ]
    Subjects are presented with a list of 15 words at a rate of one word/second with a pause between words of one second. Immediately following the presentation subjects are asked to recall and name as many words as possible. The total number of words recalled after three repeated presentations of the same list of words is the outcome variable


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pollen provocation with systemic treatment
Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution
 Drug: cetirizine 10 mg
cetirizine 10 mg overencapsulated
Experimental: Pollen provocation with topical treatment
treatment with 25ug fluticasonfuroaat after a nasal pollen challenge
 Drug: fluticasonfuroaat
nasal spray 25ug per dose
Placebo Comparator: placebo treatment after pollen challenge
Placebo treatment after a nasal challenge with pollen solution
 Drug: placebo
a placebo nasal spray and placebo capsule are available for double dummy treatment
No Intervention: control condition
A placebo drug is administered after a sham nasal challenge with a pollen solution

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318681

Contacts
Contact: Eric Vuurman, PhD +31433881046 eric.vuurman@maastrichtuniversity.nl
Contact: anita van Oers +31433881035 anita.vanoers@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 62ooMD
Contact: Eric Vuurman, PhD     +31433881046     eric.vuurman@maastrichtuniversity.nl    
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Dr. Eric Vuurman, Maastricht University
ClinicalTrials.gov Identifier: NCT01318681     History of Changes
Other Study ID Numbers: EPU-055
Study First Received: March 17, 2011
Last Updated: March 17, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
driving, memory, cognition

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Cetirizine
 Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013