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

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Cetirizine; Fexofenadine; Levocetirizine

Criteria

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