Titre du document / Document title

Double-blind, placebo-controlled study comparing the efficacy and safety of fexofenadine hydrochloride (120 and 180 mg once daily) and cetirizine in seasonal allergic rhinitis

Auteur(s) / Author(s)

HOWARTH P. H. ⁽¹⁾ ; STEM M. A. ⁽²⁾ ; ROI L. ⁽³⁾ ; REYNOLDS R. ⁽⁴⁾ ; BOUSQUET J. ⁽⁵⁾ ;

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

⁽¹⁾ Respiratory Cell and Molecular Biology Division, Southampton General Hospital, Southampton, ETATS-UNIS
⁽²⁾ Department of Clinical Immunology, Leicester General Hospital, Leicester, ETATS-UNIS
⁽³⁾ Hoechst Marion Roussel, Denham, ROYAUME-UNI
⁽⁴⁾ Hoechst Marion Roussel, Kansas City, MO, ETATS-UNIS
⁽⁵⁾ CHU Montpellier, Hôpital Arnaud de Villeneuve, Montpellier, FRANCE

Résumé / Abstract

Background: Fexofenadine hydrochloride (HCI) is a new H₁ antihistamine used twice daily in some countries. Objective: A multicenter, double-blind, parallel-group, placebo-controlled trial compared the efficacy and safety of fexofenadine HCI (120 and 180 mg administered once daily) and cetirizine (10 mg once daily) in the treatment of seasonal allergic rhinitis. Methods: After a 3- to 5-day run-in period, patients meeting entrance criteria were randomized to receive placebo, fexofenadine HCI 120 mg once daily, fexofenadine HCI 180 mg once daily, or cetirizine 10 mg once daily (active control) for 2 weeks. Eight hundred twenty-one patients comprised the intention-to-treat population and 722 patients completed the study. Symptom assessments were conducted 12 hours after the dose for the previous 12 hours and again at 24 hours after the dose for the previous 12 hours. In addition, assessment was made immediately before dosing in the morning for the previous 30 minutes. Total symptom score was calculated as the sum of scores for the 4 individual symptoms: (1) sneezing, (2) rhinorrhea, (3) itchy nose, palate, or throat, and (4) itchy, watery, or red eyes; the nasal congestion score was also recorded. Results: Both doses of fexofenadine HCI were superior to placebo in reducing the total symptom score. Efficacy was maintained for the entire dosing interval (ie, for 24 hours). There were no differences in efficacy between the 2 doses of fexofenadine HCI or between either dose of fexofenadine HCI and cetirizine. There was no major side effect, but the combined incidence of drowsiness or fatigue was greater with cetirizine (9%) than with placebo (4%) (P = .07) or fexofenadine (4%) (P =.02). Conclusions: Once-daily fexofenadine is thus a valuable addition to the nonsedating group of H₁ receptor antagonists currently available for the treatment of seasonal allergic rhinitis.

Revue / Journal Title

Journal of allergy and clinical immunology   ISSN 0091-6749   CODEN JACIBY 

Source / Source

1999, vol. 104, n^o5, pp. 927-933 (22 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, New York, NY, ETATS-UNIS  (1971) (Revue)

Mots-clés anglais / English Keywords

Rhinitis ; Allergy ; Treatment ; Fexofenadine ; Antagonist ; H1 Histamine receptor ; Cetirizine ; Antihistaminic ; Posology ; Administration schedule ; Comparative study ; Double blind study ; Chemotherapy ; Human ; ENT disease ; Nose disease ; Immunopathology ;

Mots-clés français / French Keywords

Rhinite ; Allergie ; Traitement ; Fexofénadine ; Antagoniste ; Récepteur histaminergique H1 ; Cétirizine ; Antihistaminique ; Posologie ; Rythme administration ; Etude comparative ; Etude double insu ; Chimiothérapie ; Homme ; ORL pathologie ; Nez pathologie ; Immunopathologie ;

Mots-clés espagnols / Spanish Keywords

Rinitis ; Alergia ; Tratamiento ; Fexofenadina ; Antagonista ; Receptor histaminérgico H1 ; Cetirizina ; Antihistamínico ; Posología ; Ritmo administración ; Estudio comparativo ; Estudio doble ciego ; Quimioterapia ; Hombre ; ORL patología ; Nariz patología ; Inmunopatología ;

Localisation / Location

INIST-CNRS, Cote INIST : 2059, 35400008037385.0060