Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

Condition(s) targeted: Rhinitis, Allergic, Seasonal

Intervention: Levocetirizine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB

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

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.

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.

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

Primary outcome: 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 outcome: Reduction in other SAR symptoms at different time points; Safety .

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Mississauga, Ontario, Canada

Starting date: July 2006
Ending date: October 2006
Last updated: March 7, 2008