Original Articles: Interventions
Safety and tolerability of fexofenadine for the treatment of allergic rhinitis in children 2 to 5 years old

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Background

The safety of fexofenadine has been examined extensively in adults and school-age children. However, the safety of fexofenadine in children younger than 6 years has not been reported to date.

Objective

To compare the safety and tolerability of twice-daily fexofenadine hydrochloride, 30 mg, and placebo in preschool children aged 2 to 5 years with allergic rhinitis.

Methods

This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study, conducted between February 29, 2000, and June 14, 2001. Participants were randomized to either fexofenadine hydrochloride, 30 mg, or placebo twice daily for a 2-week period. To facilitate dosing, capsule content was mixed with applesauce (approximately 10 mL). Safety assessments depended on date of entry into the study because of an amendment to the protocol. Before the amendment, assessments included physical examination, vital signs reporting (oral temperature, heart rate, and respiratory rate), and adverse event (AE) reporting. After the amendment, safety assessments included laboratory testing (blood chemistry and hematology profiles), physical examination, 12-lead electrocardiography, and vital signs (oral temperature, blood pressure, heart rate, and respiratory rate) and AE reporting.

Results

Treatment-emergent AEs were observed in 116 of 231 participants receiving placebo and 111 of 222 receiving fexofenadine. These AEs were possibly related to study medication in 19 (8.2%) and 21 (9.5%) of the participants receiving placebo and fexofenadine, respectively, and most frequently involved the digestive system. No clinically relevant differences in laboratory measures, vital signs, and physical examinations were observed.

Conclusions

The findings show that fexofenadine hydrochloride, 30 mg, is well tolerated and has a good safety profile in children aged 2 to 5 years with allergic rhinitis.

Section snippets

INTRODUCTION

Allergic rhinitis (AR) is the most common chronic disease in children.1, 2 It is estimated to affect up to 40% of children in the United States,1 and the incidence of the disease is increasing in children worldwide.3, 4, 5 The symptoms of AR may appear in infancy, with the diagnosis generally established by the age of 6 years. Poorly controlled AR may lead to onset or exacerbation of comorbid conditions, such as asthma, sinusitis, respiratory infections, nasal polyps, otitis media, and/or

Study participants

Approximately 500 male and female children with AR aged 2 to 5 years were to be enrolled and equally distributed across the age groups. The diagnosis of AR was supported by previous medical history and 1 or more of the following physical signs: clear nasal discharge, swelling and/or changes in color of turbinates, or cobblestoning (ie, dimpled appearance).

Children were excluded if they had clinically relevant abnormalities or medical conditions that could interfere with the study (eg, severe

Study participants

The baseline characteristics of the study population are presented in Table 1. A total of 453 children were enrolled at 30 study sites (fexofenadine, n = 222; placebo, n = 231). No significant differences were found in the demographics across groups. A total of 180 fexofenadine-treated children and 178 placebo-treated children completed the study; children were considered to have completed the study if treatment duration was 12 days or more and they had ingested 22.5 doses or more (80% of the

DISCUSSION

Fexofenadine hydrochloride, 30 mg twice daily, was well tolerated, with a good safety profile, in children aged 2 to 5 years with AR in this study. In a population pharmacokinetic analysis, a 30-mg dose of fexofenadine hydrochloride in children aged 1 to 12 years and weighing more than 10.5 kg produced similar exposures to that of a 60-mg dose in adults. This finding suggests that fexofenadine hydrochloride, 30 mg, may be an appropriate dose for children aged 2 to 5 years and validates the

ACKNOWLEDGMENTS

We thank the study investigators and, in addition, Lesley Brewer, BSc (Hons), Medicus International, for her editorial assistance with the manuscript. Editorial assistance was funded by sanofi-aventis US Inc.

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  • Cited by (0)

    Dr Milgrom is on the speaker's bureau for Novartis and Genentech and has received funding support from Novartis, GlaxoSmithKline, AstraZeneca, and sanofi-aventis. Dr Lanier is on the speaker's bureau for Alcon Laboratories, Schering Laboratories, and Sanofi; is an investigator for Alcon Laboratories, Schering Laboratories, Sanofi, and Genentech; and is a consultant for Alcon Laboratories and Schering Laboratories. Dr Hampel has received, during the last 2 years, research support from the following companies: Alcon Research Ltd, Allux Medical, Altana Pharma, Amphastar Pharmaceuticals Inc, Apotex Inc, Boehringer-Ingelheim, Collegium, Dynavax, Emergent Biosolutions, GlaxoSmithKline, Inspire Pharmaceuticals Inc, MAP Pharmaceuticals Inc, MedImmune Inc, MedPointe Pharmaceuticals, Merck Research Laboratories, Morton Grove Pharmaceuticals, Novartis Pharmaceuticals, Pharmaxis Ltd, Sankyo Pharma Development, sanofi-aventis, Schering-Plough, Sepracor Inc, SkyePharma, and SUN Pharmaceuticals. Dr Kittner is a full-time employee of sanofi-aventis US Inc.

    Financial support for this study was provided by sanofi-aventis US Inc.

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