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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levocetirizine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No