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

UCB Pharma403 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

403

Conditions

Rhinitis, Allergic, Seasonal

Interventions

LevocetirizineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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