Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Levocetirizine oral solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levocetirizine oral solution|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis, safety, levocetirizine, children, Xyzal