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

UCB

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544388

A00379

Details and patient eligibility

About

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.

Enrollment: 570 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind