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

摘要: 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 all symptoms throughout entire treatment period. Objective: placebo-controlled, parallel-group, double-blind was performed to assess efficacy and safety fexofenadine rhinitis. Methods: conducted at 148 centers 15 countries. Nine hundred thirty-five (aged 6-11 years) were randomized treated either HCl 30 mg (n = 464) or placebo 471) tablets twice a day for 14 days. Individual (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, red eyes; nasal congestion) assessed baseline then daily 7:00 AM PM (±1 hour) during Each total symptom score sum symptoms, excluding congestion. The primary variable change from average 12-hour evening reflective scores treatment. Safety evaluated adverse-event reporting, vital signs, physical examinations, clinical laboratory data screening end point. Results: Fexofenadine significantly superior analysis ( P ≤ .0001). showed statistically significant superiority compared has been confirmed this multicenter, multinational aged 6 11 years