Official Title: “Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Study Primary Completion Date: December 2002

Intervention(s) in this Clinical Trial

• Drug: levocetirizine dihydrochloride

Primary Measures

• Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Measures

• The change from baseline of the mean MSC score over time interval 3
• the change from baseline of the mean MSC score over time intervals 1 and 4.

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/intollerance to lactose, cellullose, cornstarch
• presence of nasal anatomical deformities leading to > 50% obstruction
• ENT infection within 30 days of the study
• use of disallowed medication
• ongoing desensitivation
• known cardiac, renal or hepatic dysfunction
• presenting allergic bronchial asthma
• use of cimetidine
• intenting to donate blood during the trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Marie-Etienne Pinelli, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542607

Study ID Number: A00324

ClinicalTrials.gov Identifier: NCT00542607

Health Authority: Austria: Federal Office for Safety in Health Care