Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

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

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Keywords

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Levocetirizine dihydrochloride Xyzal tablet

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 dihydrochloride

Intervention Type DRUG

Eligibility Criteria

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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 sinusitis within 30 days of Period 2
* initiated or advanced an immunotherapy regimen
* immunotherapy injections within 48 hours of pollen exposure
* impaired hepatic function
* history of malignancy
* intolerance to histamines
* asthma requiring medication more than occasionally

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

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A00379

Identifier Type: -

Identifier Source: org_study_id