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Rhinitis, Cognition and Driving Performance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01318681
First Posted: March 18, 2011
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vuurman, Maastricht University Medical Center
  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 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)

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

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

Resource links provided by NLM:


Further study details as provided by Vuurman, 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 ]
    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:
  • Word Learning Test (WLT-15) verbal memory score [ Time Frame: 2:30 hrs post dosing ]
    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


Enrollment: 22
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: March 2012 (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 over encapsulated
Experimental: Pollen provocation with topical treatment
treatment with 25ug fluticasone furoate after a nasal pollen challenge
Drug: fluticasone furoate
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318681


Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 62ooMD
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

Responsible Party: Vuurman, DR Eric Vuurman, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01318681     History of Changes
Obsolete Identifiers: NCT01239264
Other Study ID Numbers: EPU-055
First Submitted: March 17, 2011
First Posted: March 18, 2011
Last Update Posted: November 8, 2013
Last Verified: March 2011

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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Cetirizine
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action