Facial Thermography Study of Levocetirizine Versus Cetirizine

Phase 4

Completed

• Conditions: Anti-allergic Agents

• Registration Number: NCT00150761
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2009-09
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 immunotherapy
• Skin irritants or UV exposure 48 hours before each visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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