Facial Thermography Study of Levocetirizine Versus Cetirizine

• ClinicalTrials.gov Identifier: NCT00150761
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Last Update Posted: August 26, 2014
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anti-allergic Agents	Drug: Levocetirizine (drug)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• 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 Start Date: July 2004
• Actual Primary Completion Date: October 2004
• Actual Study Completion Date: October 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg
2. To explore predictive value of screening thermography parameters on treatment effect
3. To collect additional safety information on levocetizine

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes 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 immunotherapy
• Skin irritants or UV exposure 48 hours before each visit.

Contacts and Locations

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

More Information

• ClinicalTrials.gov Identifier: NCT00150761
• Other Study ID Numbers: A00380
• First Posted: September 8, 2005
• Last Update Posted: August 26, 2014
• Last Verified: September 2009

Keywords provided by UCB Pharma:

Nasal histamine provocation, facial thermography, levocetirizine, cetirizine,; Xyzal, Zyrtec

Additional relevant MeSH terms:

Levocetirizine; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs