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

UCB

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Levocetirizine oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152412

A00385

Details and patient eligibility

About

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

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.