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

Basic Information

• 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

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

Conditions

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Levocetirizine dihydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

A00306

Identifier Type: -

Identifier Source: org_study_id