Rhinitis, Cognition and Driving Performance

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318681
• Other study ID #: EPU-055
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: November 7, 2013
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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)

Other known NCT identifiers

• NCT01239264

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cognition
• Driving Ability
• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• cetirizine 10 mg
cetirizine 10 mg over encapsulated
• fluticasone furoate
nasal spray 25ug per dose
• placebo
a placebo nasal spray and placebo capsule are available for double dummy treatment

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Word Learning Test (WLT-15) verbal memory score	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	2:30 hrs post dosing	No