Official Title: “A Randomized, Double-Blind, Double Dummy, Placebo Controlled, Cross-Over Exploratory Trial in Healthy Male Adult Subjects: Comparison by Means of Infrared Thermography of the Anti-H1 Potency of Levocetirizine 5 mg and Cetirizine 10 mg Tablet Single Oral Dose After Nasal Histamine Provocation.”

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.

Study Type: Interventional

Study Design: Randomized, Double-Blind, Active Control, Crossover Assignment

Study Primary Completion Date: October 2004

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine (drug)

Primary Measures

• 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 Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Marie-Etienne Pinelli, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150761

Study ID Number: A00380

ClinicalTrials.gov Identifier: NCT00150761

Health Authority: Germany: Federal Institute for Drugs and Medical Devices