Effects of treated and untreated Allergic Rhinitis on Mood, Cognitive functions and Actual Driving Performance - Rhinitis and Driving

INTERVENTION: Trade Name: Cetirizinedihydrochloride Product Name: cetirizine 10mg Pharmaceutical Form: Over encapsulated tablet Pharmaceutical form of the placebo: Over encapsulated tablet Route of administration of the placebo: Oral use Trade Name: Avamys Product Name: fluticasonfuroaat Pharmaceutical Form: Nasal spray, suspension Pharmaceutical form of the placebo: Nasal spray, emulsion Route of administration of the placebo: Nasal use CONDITION: Seasonal Allergic Rhinitis ; MedDRA version: 12.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis PRIMARY OUTCOME: Main Objective: To study the effects of Seasonal Allergic Rhinitis on Cognitive functions and actual driving and the modifying effect of treatment with systemic or topical medication Primary end point(s): The primary endpoints are the performance on a standard driving test and the performance on a verbal memory test. Related outcome variables are:; ; · Standard Highway Test; Primary outcome variable: Standard Deviation of Lateral Position (SDLP): cm.; Secondary outcome variable: Standard Deviation of Speed (SDSP): km.; ; . WLT‐ 15 Memory test; Primary outcome variable: Total words recalled (Immediate recall); Secondary outcome variable: Total words recalled after 30 minutes (delayed recall); Secondary Objective: To study the effects of Seasonal Allergic Rhinitis on Mood INCLUSION CRITERIA: 1. All patients must be normal healthy males or females, age between 21 and 45 years, diagnosed with seasonal AR (SAR), also known as Intermittent Rhinitis (ITR); Anti‐allergic treatment during the previous season, positive radioallergosorbent test for serum‐specific immunoglobulin E or positive skin prick test for tree/ and/or grass‐ and/or weed pollen. The severity of nasal symptoms (itching, secretion, sneezing and congestion) is rated by the Allergy Symptom Check List (ASCL, Kremer et al 2002); before a nasal challenge is performed patients should score less than four. 2. Patients must be experienced drivers. That is, each shall have held a driver’s license for at least the preceding two years and shall have driven more than 5,000 km/yr (3,000 miles/yr) during that period. 3. Patients must be in general good health as confirmed by routine clinical and laboratory testing. Clinical laboratory tests ( CBC, blood chemistries, and urinalysis) must be within