Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.

Condition	Intervention	Phase
Anti-allergic Agents	Drug: Levocetirizine (drug)	Phase IV

Further Study Details: 

Primary Outcomes: To compare by means of infrared (IR) thermography the anti-histaminic potency of levocetirizine 5mg (single dose) and cetirizine 5mg (single dose) using a placebo as control following 2 nasal histamine provocations (NHP) performed respectively 10 minutes
Secondary Outcomes: To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg; To explore predictive value of screening thermography parameters on treatment effect; To collect additional safety information on levocetizine
Expected Total Enrollment:  60

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Healthy male Caucasian subject aged between 18 and 55 years (both inclusive).
• Subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/mL) and ≤ 3 mm with diluent control).

Exclusion Criteria:

• History of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy.
• Any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc.
• History of hot flushes and any other vasomotor disorders.
• ENT infection or Upper Respiratory Tract Infection not completely cured at least one week before inclusion.
• Any known history of laryngeal edema.
• Nasal structural abnormalities (e.g. deviation of the nasal septum…).
• Recent immunotheray
• Skin irritants or UV exposure 48 hours before each visit.

Study chairs or principal investigators

Marie-Etienne Pinelli, MD,  Study Director,  UCB Pharma, Inc.   

Study ID Numbers:  A00380; EudraCT 2004-000295-13
Last Updated:  September 9, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150761
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13