Efficacy and Safety of Fexofenadine Hydrochloride for Pediatric Perennial Allergic Rhinitis in a Phase III, Randomized, Double-blind, Multi-center Comparative Study

The efficacy and safety of fexofenadine hydrochloride at a daily dose of 30 mg twice daily (for 7-to 11-year-olds) or 60 mg twice daily (for 12-to 15-year-olds) in patients with perennial allergic rhinitis were evaluated in a randomized, double-blind, multi-center,4-week comparative study. This study was designed to examine the non-inferiority of fexofenadine hydrochloride to ketotifen fumarate dry syrup (1 mg bid).One hundred and forty-seven patients were enrolled in the study, and the safety was analyzed in 146patients, after one ineligible patient excluded from analysis. The primary efficacy was evaluated for 127patients (fexofenadine,64 patients; ketotifen,63 patients).Fexofenadine and ketotifen both reduced the total symptom scores (sum total of the individual scores for sneezing, rhinorrhea, nasal congestion), and the non-inferiority of fexofenadine to ketotifen fumarate was verified. Both treatments improved all individual nasal symptom scores, while fexofenadine improved individual scores for nasal congestion significantly better than ketotifen.The frequency of adverse events was similar between the fexofenadine and ketotifen arms, but the frequency of side effects (fexofenadine,5.3%; ketotifen,23.9%) and sedative effects (fexofenadine,2.7%; ketotifen,14.1%) were significantly lower for the fexofenadine arm (P = 0.0115 and P = 0.0 151, respectively). There were no serious adverse events reported in patients given fexofenadine. There was no prolongation of QTc in patients receiving either treatment.Based on these findings, fexofenadine hydrochloride at 30 mg twice daily (for 7-to 11-year-olds) and 60 mg twice daily (for 12-to 15-year-olds) was found to reduce the symptom scores without causing any serious adverse events or adverse events of any clinical significance. It is concluded that fexofenadine hydrochloride is clinically useful in the treatment of pediatric perennial allergic rhinitis.