Official Title: “Double-Blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.”

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Study Type: Interventional

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

Study Primary Completion Date: October 2006

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine

Primary Measures

• Compare efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.

Secondary Measures

• Reduction in other SAR symptoms at different time points; Safety .

Inclusion Criteria:

• Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
• Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

• Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
• Have used forbidden concomitant medications as defined by the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Marie-Etienne Pinelli, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00315523

Study ID Number: A00415

ClinicalTrials.gov Identifier: NCT00315523

Health Authority: Canada: Health Canada