Titre du document / Document title

Safety of fexofenadine in children treated for seasonal allergic rhinitis

Auteur(s) / Author(s)

GRAFT David F. ⁽¹⁾ ; BERNSTEIN David I. ⁽²⁾ ; GOLDSOBEL Alan ⁽³⁾ ; MELTZER Eli O. ⁽⁴⁾ ; PORTNOY Jay ⁽⁵⁾ ; LONG Joseph ⁽⁶⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Park Nicollet Clinic, Minneapolis, MN, ETATS-UNIS
⁽²⁾ Bernstein Clinical Research Center, Cincinnati, OH, ETATS-UNIS
⁽³⁾ Allergy & Asthma Associates of Northern California Research Center, San Jose, CA, ETATS-UNIS
⁽⁴⁾ Allergy and Asthma Medical Group and Research Center, San Diego, CA, ETATS-UNIS
⁽⁵⁾ Allergy/Asthma Research, Kansas City, MO, ETATS-UNIS
⁽⁶⁾ Aventis Pharmaceuticals, Inc., Kansas City, MO, ETATS-UNIS

Résumé / Abstract

Background: The incidence of allergic rhinitis in children is increasing. Objective: To evaluate the safety of fexofenadine HCl in children ages 6 through 1 1 years for treatment of seasonal allergic rhinitis. Methods: Two large, double-blind, randomized, placebo-controlled, parallel studies with identical protocols included patients with a positive skin test to fall allergen(s) and allergic rhinitis symptoms. Patients were randomized to receive fexofenadine 15, 30, or 60 mg or placebo twice daily for 2 weeks after a 1-week placebo lead-in. Safety was evaluated through adverse event reporting, electrocardiograms, and pre- and posttreatment laboratory panels and physical examinations. Results: A total of 875 patients from both studies were eligible for safety analyses. Ten patients (5 on placebo, 5 on fexofenadine) discontinued because of an adverse event; no event that resulted in discontinuation was judged to be caused by study medication. Incidence of adverse events was similar in active and placebo groups, and did not increase with increasing fexofenadine dose: 36.2% (83 of 229) in the placebo group versus 35.3% (79 of 224), 36.8% (77 of 209), and 34.7% (74 of 213) in the 15, 30, and 60 mg twice-daily fexofenadine groups, respectively. Headache was the most commonly reported adverse event (6.6%, 8.0%, 7.2%, and 9.4% in the placebo, 15, 30, 60 mg twice-daily fexofenadine groups, respectively). Clinical, vital sign, electrocardiogram, and laboratory measures were similar in active and placebo groups. There was no statistically significant mean change from baseline in any electrocardiogram parameter after fexofenadine treatment. Conclusions: Fexofenadine, 15, 30, and 60 mg twice daily, was safe and well tolerated in this large pediatric patient population.

Revue / Journal Title

Annals of allergy, asthma, & immunology   ISSN 1081-1206 

Source / Source

2001, vol. 87, n^o1, pp. 22-26 (20 ref.)

Langue / Language

Anglais

Editeur / Publisher

American College of Allergy, Asthma, & Immunology, McLean, VA, ETATS-UNIS  (1995) (Revue)

Mots-clés anglais / English Keywords

Rhinitis ; Allergy ; Child ; School age ; Treatment efficiency ; Treatment ; Chemotherapy ; Double blind study ; Randomization ; Fexofenadine ; Antihistaminic ; Antagonist ; H1 Histamine receptor ; Controlled therapeutic trial ; Multiple dose ; Administration schedule ; Human ; ENT disease ; Nose disease ; Immunopathology ;

Mots-clés français / French Keywords

Rhinite ; Allergie ; Enfant ; Age scolaire ; Efficacité traitement ; Traitement ; Chimiothérapie ; Etude double insu ; Randomisation ; Fexofénadine ; Antihistaminique ; Antagoniste ; Récepteur histaminergique H1 ; Essai thérapeutique contrôlé ; Dose répétée ; Rythme administration ; Homme ; ORL pathologie ; Nez pathologie ; Immunopathologie ;

Mots-clés espagnols / Spanish Keywords

Rinitis ; Alergia ; Niño ; Edad escolar ; Eficacia tratamiento ; Tratamiento ; Quimioterapia ; Estudio doble ciego ; Aleatorización ; Fexofenadina ; Antihistamínico ; Antagonista ; Receptor histaminérgico H1 ; Ensayo terapéutico controlado ; Dosis múltiple ; Ritmo administración ; Hombre ; ORL patología ; Nariz patología ; Inmunopatología ;

Localisation / Location

INIST-CNRS, Cote INIST : 5910, 35400009909954.0040