Official Title: “Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).”

Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Study Primary Completion Date: July 2004

Intervention(s) in this Clinical Trial

• Drug: levocetirizine dihydrochloride

Primary Measures

• Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).

Secondary Measures

• Mean change from baseline in MSC score over each 2-hour interval.

Inclusion Criteria:

• Male/Female, aged >= 16 years
• seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
• documented seasonal allergy to ragweed pollen
• total symptom score of at least 18 points.

Exclusion Criteria:

• nasal anatomic deformities ? 50% obstruction
• acute sinusitus within 30 days of Period 2
• initiatedor advanced an immunotherapy regimen
• immunotherapy injections within 48 hours of pollen exposure
• impaired hepatic function
• history of malignancy
• intolerance to histamines
• astma requiring medication more than occasional

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Marie-Etienne Pinelli, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00544388

Study ID Number: A00379

ClinicalTrials.gov Identifier: NCT00544388

Health Authority: Canada: Health Canada