Rhinitis, Cognition and Driving Performance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vuurman, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01318681
First received: March 17, 2011
Last updated: November 7, 2013
Last verified: March 2011
  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
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:


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:
  • Word Learning Test (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
Study First Received: March 17, 2011
Last Updated: November 7, 2013
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
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
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
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 31, 2014