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Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

NCT ID: NCT00521040

Last Updated: 2013-12-12

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

NA

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-07-31

Brief Summary

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Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

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

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 or female subjects ≥ 12 years
* 2 year history of seasonal allergic rhinitis
* documented hypersensitivity to local seasonal allergens (grass pollen)
* documented pollen-induced asthma
* without acute ongoing exacerbation of asthma or allergic rhinitis
* no continuous ongoing treatment for rhinitis or asthma

Exclusion Criteria

* non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity
* symptomatic rhinitis or asthma due to tree pollens
* currently treated by specific grass pollen immunotherapy
* suffering from non-allergic asthma
* chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma
* atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
* contraindication for salbutamol use
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

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A00306

Identifier Type: -

Identifier Source: org_study_id