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

Condition(s) targeted: Allergic Rhinitis

Intervention: Levocetirizine oral solution (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: UCB

Official(s) and/or principal investigator(s):
Isabelle Campine, MD, Study Director, Affiliation: UCB

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: 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.

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

Primary outcome: 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:

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

Minimum age: 2 Years. Maximum age: 6 Years. Gender(s): 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.

Starting date: June 2004
Ending date: December 2004
Last updated: March 6, 2008