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Clinical Trial
. 2003 Apr;111(4):763-9.
doi: 10.1067/mai.2003.1384.

Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis

Ulrich Wahn  1 , Eli O Meltzer, Albert F Finn Jr, Marek L Kowalski, Paola Decosta, Gunilla Hedlin, Pierre Scheinmann, Claus Bachert, Jose E Rosado Pinto, Carlos Baena-Cagnani, Paul Potter, F Estelle R Simons, Erik Ruuth
Affiliations
Free article
Clinical Trial

Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis

Ulrich Wahn et al. J Allergy Clin Immunol. 2003 Apr.
Free article

Erratum in

  • J Allergy Clin Immunol. 2003 Dec;112(6):1202
  • J Allergy Clin Immunol. 2003 Jul;112(1):71

Abstract

Background: This is the first prospective, randomized, double-blind, placebo-controlled study showing statistical improvement of an H(1)-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period.

Objective: This randomized, placebo-controlled, parallel-group, double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis.

Methods: This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (+/-1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point.

Results: Fexofenadine was significantly superior to placebo in the primary efficacy analysis (P </=.0001). Individual symptom scores showed statistically significant superiority compared with placebo (P <.05), including nasal congestion in the evening reflective assessment (P <.05). There was no significant difference in adverse events between fexofenadine and placebo, either overall or by causality.

Conclusion: The efficacy and safety of the H(1)-antihistamine fexofenadine has been confirmed in this multicenter, multinational study of children aged 6 to 11 years with seasonal allergic rhinitis.

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