Effects of Allergic Rhinitis on Cognition and Driving (upu055)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by Maastricht University Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01239264

First received: November 10, 2010

Last updated: NA

Last verified: November 2010

History: No changes posted

Purpose

Previous research has shown that patients suffering from Allergic Rhinitis (AR) not only suffer from direct symptoms of their condition but also report a decreased quality of life. More specific this relates not only to psychological wellbeing but also to diminished cognitive functions such as memory and concentration. In a recent study of a group the investigators showed that in tasks with a higher and longer lasting cognitive load symptomatic AR patient performed significantly worse compared to controls. The finding of a direct relationship between AR symptoms and cognitive functioning strongly suggests implications of AR daily life functioning, safety and workplace productivity. Whereas untreated AR was previously thought only to affect subjective wellbeing it now seems that cognitive functioning might be directly impaired which could lead to potentially dangerous situations in daily life such as driving a car or operating machinery. In this study the investigators will research the effect of an allergen challenge in AR patients on actual driving and memory functions. A comparison in performance will be made between untreated patients and patients treated with systemic or topical drugs.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: cetirizine 10mg and Fluticasone Furoate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Drug Information available for: Fluticasone propionate Cetirizine Cetirizine hydrochloride Fluticasone Fluticasone furoate

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Standard Deviation of Lateral Position (SDLP) [ Time Frame: 90 - 150 minutes post challenge ] [ Designated as safety issue: No ]
Primary measure is performance in an over the road driving test as measured by the ability to keep within the boundaries of the slower traffic of a highway during a 60 minute driving test

Secondary Outcome Measures:

WLT 15 memory test score [ Time Frame: 120 minutes post challenge ] [ Designated as safety issue: No ]
The secondary outcome score is the total number of words correctly remembered on a 15-word learning test administered during the driving test

Estimated Enrollment:	20
Study Start Date:	November 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo drug + placebo pollen challenge Placebo treatment after placebo (sham) nasal pollen challenge	Drug: cetirizine 10mg and Fluticasone Furoate Subjects will undergo a nasal pollen challenge or sham challenge followed by treatment with either a systemic, topical or placebo treatment.
Active Comparator: placebo drug + active pollen challenge A placebo treatment with active pollen nasal challenge	Drug: cetirizine 10mg and Fluticasone Furoate Subjects will undergo a nasal pollen challenge or sham challenge followed by treatment with either a systemic, topical or placebo treatment.
Experimental: Systemic drug + active pollen treatment	Drug: cetirizine 10mg and Fluticasone Furoate Subjects will undergo a nasal pollen challenge or sham challenge followed by treatment with either a systemic, topical or placebo treatment.
Experimental: topical drug + active pollen challenge	Drug: cetirizine 10mg and Fluticasone Furoate Subjects will undergo a nasal pollen challenge or sham challenge followed by treatment with either a systemic, topical or placebo treatment.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Diagnosed as SAR patient
Experienced driver

Exclusion Criteria:

History of neurological or psychiatric disease
use of psychoactive medication
clinical abnormalities at medical screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239264

Locations

Netherlands
Maastricht University	Not yet recruiting
Maastricht, Limburg, Netherlands, 6200MD
Contact: Eric Vuurman, PhD +31433881046 eric.vuurman@maastrichtuniversity.nl
Principal Investigator: Eric Vuurman, PhD

Sponsors and Collaborators

Maastricht University Medical Center

More Information

Publications:

Hartgerink-Lutgens I, Vermeeren A, Vuurman E, Kremer B. Disturbed cognitive functions after nasal provocation in patients with seasonal allergic rhinitis. Clin Exp Allergy. 2009 Apr;39(4):500-8. Epub 2009 Feb 16.

Vuurman E, Theunissen E, van Oers A, van Leeuwen C, Jolles J. Lack of effects between rupatadine 10 mg and placebo on actual driving performance of healthy volunteers. Hum Psychopharmacol. 2007 Jul;22(5):289-97.

Vuurman EF, Rikken GH, Muntjewerff ND, de Halleux F, Ramaekers JG. Effects of desloratadine, diphenhydramine, and placebo on driving performance and psychomotor performance measurements. Eur J Clin Pharmacol. 2004 Jul;60(5):307-13. Epub 2004 May 28.

Responsible Party:	Dr. Eric Vuurman, Maastricht University
ClinicalTrials.gov Identifier:	NCT01239264 History of Changes
Other Study ID Numbers:	10.1.044
Study First Received:	November 10, 2010
Last Updated:	November 10, 2010
Health Authority:	The Netherlands: The central committee on research involving human subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

Seasonal Allergic Rhinitis
Driving performance
memory
mood

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
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013

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