Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

UCB

Status and phase: Completed; Phase 4

Conditions: Rhinitis; Perennial; Allergic

Treatments: Drug: Levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00521131

A00333

Details and patient eligibility

About

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Enrollment: 453 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female ≥ 12 years
• suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
• positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
• the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion criteria

• seasonal allergic rhinitis likely to change significantly the symptoms of the subject
• an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
• asthma requiring corticosteroid treatment
• atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
• associated ENT disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind