Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

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

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2002-12-31

Brief Summary

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No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Keywords

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Levocetirizine dihydrochloride Xyzal tablets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

* adults 18 to 55 years both inclusive
* suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
* positive RAST and/or positive skin prick test
* comply with study restrictions

Exclusion Criteria

* known alcohol or drug addiction or abuse
* known allergy/intolerance to lactose, cellulose, cornstarch
* presence of nasal anatomical deformities leading to \> 50% obstruction
* ENT infection within 30 days of the study
* use of disallowed medication
* ongoing desensitization
* known cardiac, renal or hepatic dysfunction
* presenting allergic bronchial asthma
* use of cimetidine
* intending to donate blood during the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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A00324

Identifier Type: -

Identifier Source: org_study_id