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

UCB

Status: Completed

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00521040

A00306

Details and patient eligibility

About

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

Enrollment: 459 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind