Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

UCB

Status and phase: Completed; Phase 4

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542607

A00324

Details and patient eligibility

About

No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Enrollment: 94 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults 18 to 55 years both inclusive
• suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
• positive RAST and/or positive skin prick test
• comply with study restrictions

Exclusion criteria

• known alcohol or drug addiction or abuse
• known allergy/intolerance to lactose, cellulose, cornstarch
• presence of nasal anatomical deformities leading to > 50% obstruction
• ENT infection within 30 days of the study
• use of disallowed medication
• ongoing desensitization
• known cardiac, renal or hepatic dysfunction
• presenting allergic bronchial asthma
• use of cimetidine
• intending to donate blood during the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind