Official Title: “A 4 Week Open, Multi-Center Study Evaluating the Safety of Levocetirizine 1.25 mg b.i.d. Given as 0.5 mg/mL Oral Solution in 2 to 6 Year-Old Children Suffering From Allergic Rhinitis.”

4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years) suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy of the treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each of the 4 individual rhinitis symptom scores

Study Type: Interventional

Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: December 2004

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine oral solution

Primary Measures

• To assess safety of levocetirizine 1.25 mg bid given as 0.5 mg/mL oral solution in 2 to 6 years old children suffering from allergic rhinitis over 4 weeks of treatment

Secondary Measures

• To assess efficacy of 1.25 mg levocetirizine 0.5 mg/mL oral solution bid in 2 to 6 years old children suffering from allergic rhinitis over 4 weeks by means of the T4SS and each of the 4 individual rhinitis
• To describe the serum concentration of levocetirizine after 1,3 and 6 hours following the last treatment intake

Inclusion Criteria:

• At Visit 1:
• Male or female outpatients aged 2 to 6 years old.
• Subjects suffering from allergic rhinitis (perennial and/or seasonal) and symptomatic as attested by the Daily Record Card (DRC).
• At Visit 2:
• Respected wash-out periods for the forbidden medication.

Exclusion Criteria:

• • Presence of asthma requiring treatment by inhaled corticosteroids.
• Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids, or any other disease requiring the administration of oral or topical corticosteroids, immunomodulatory drugs, anti-inflammatory, or cytotoxic drugs.
• Use during the course of the study, or during the specific wash-out periods, of any of the following medications: intranasal or systemic corticosteroids (within 7 days), ketotifen (within 7 days), nedocromil or cromoglicate (within 7 days), loratadine and desloratadine (within 7 days), other antihistamines (within 3 days) or decongestants (per os, nasal spray, or drops - within 3 days), or any other concomitant medications that, in the opinion of the Investigator, interfered with the study.
• Initiation or change of dose of an immunotherapy regimen during the course of the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 6 Years

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152412

Study ID Number: A00385

ClinicalTrials.gov Identifier: NCT00152412

Health Authority: France: Afssaps - French Health Products Safety Agency