Facial Thermography Study of Levocetirizine Versus Cetirizine

Condition(s) targeted: Anti-Allergic Agents

Intervention: Levocetirizine (drug) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: UCB

Official(s) and/or principal investigator(s):
Marie-Etienne Pinelli, MD, Study Director, Affiliation: UCB

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.

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.

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

Primary outcome: 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 outcome:

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): 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.

Starting date: July 2004
Ending date: October 2004
Last updated: March 6, 2008