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


CONCLUSIONS
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.
Wahn
Ulrich
U
Department of Pediatric Pneumology and Immunology, University Children's Hospital, Berlin, Germany.
Meltzer
Eli O
EO
Finn
Albert F
AF
Kowalski
Marek L
ML
Decosta
Paola
P
Hedlin
Gunilla
G
Scheinmann
Pierre
P
Bachert
Claus
C
Rosado Pinto
Jose E
JE
Baena-Cagnani
Carlos
C
Potter
Paul
P
Simons
F Estelle R
FE
Ruuth
Erik
E
D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016593:Terfenadine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D018926:Anti-Allergic Agents; D006634:Histamine H1 Antagonists; D016593:Terfenadine; C093230:fexofenadine