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

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Levocetirizine oral solution	Phase II

Further Study Details: 

Primary Outcomes: 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 Outcomes: - 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
Expected Total Enrollment:  30

Ages Eligible for Study:  2 Years   -   6 Years,  Genders Eligible for Study:  Both

Criteria

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.

Study chairs or principal investigators

Isabelle Campine, MD,  Study Director,  UCB Pharma, Inc.   

Study ID Numbers:  A00385; EudraCT number: 2004-000180-96
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152412
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13