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. 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.

[1]  F. Simons.  H1-antihistamines in children. , 2002, Clinical allergy and immunology.

[2]  J. Warner,et al.  A double-blinded, randomized, placebo-controlled trial of cetirizine in preventing the onset of asthma in children with atopic dermatitis: 18 months' treatment and 18 months' posttreatment follow-up. , 2001, The Journal of allergy and clinical immunology.

[3]  J. Bousquet,et al.  Allergic rhinitis and its impact on asthma. , 2001, The Journal of allergy and clinical immunology.

[4]  E. Meltzer,et al.  Safety of fexofenadine in children treated for seasonal allergic rhinitis. , 2001, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[5]  E. Meltzer,et al.  Quality of life in adults and children with allergic rhinitis. , 2001, The Journal of allergy and clinical immunology.

[6]  M. Triggiani,et al.  Histamine Induces Exocytosis and IL-6 Production from Human Lung Macrophages Through Interaction with H1 Receptors1 , 2001, The Journal of Immunology.

[7]  M. Triggiani,et al.  Histamine-Induced Activation of Human Lung Macrophages , 2001, International Archives of Allergy and Immunology.

[8]  M. Aubier,et al.  Effect of cetirizine on bronchial hyperresponsiveness in patients with seasonal allergic rhinitis and asthma , 2001, Allergy.

[9]  J. Bousquet,et al.  Epidemiologic evidence for asthma and rhinitis comorbidity. , 2000, The Journal of allergy and clinical immunology.

[10]  E. Juniper,et al.  Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis , 2000, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology.

[11]  B. Niggemann,et al.  The atopy patch test (APT) – a useful tool for the diagnosis of food allergy in children with atopic dermatitis , 2000, Allergy.

[12]  P. Howarth,et al.  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. , 1999, The Journal of allergy and clinical immunology.

[13]  A. Kaplan,et al.  A double-blind, placebo-controlled trial of fexofenadine HCl in the treatment of chronic idiopathic urticaria. , 1999, The Journal of allergy and clinical immunology.

[14]  E. Meltzer,et al.  Long-Term Tolerability of Fexofenadine in Healthy Volunteers , 1999 .

[15]  J. Mason,et al.  The systemic safety of fexofenadine HCl , 1999, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology.

[16]  T. Casale,et al.  Safety and efficacy of once-daily fexofenadine HCl in the treatment of autumn seasonal allergic rhinitis. , 1999, Allergy and asthma proceedings.

[17]  G. Canonica,et al.  Terfenadine and fexofenadine reduce in vitro ICAM-1 expression on human continuous cell lines. , 1998, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[18]  S. Weir,et al.  Pharmacokinetics, pharmacodynamics, and tolerance of single‐ and multiple‐dose fexofenadine hydrochloride in healthy male volunteers , 1998, Clinical pharmacology and therapeutics.

[19]  C. Zwillich,et al.  Nasal congestion secondary to allergic rhinitis as a cause of sleep disturbance and daytime fatigue and the response to topical nasal corticosteroids. , 1998, The Journal of allergy and clinical immunology.

[20]  Richard Beasley,et al.  Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC , 1998, The Lancet.

[21]  H. Bayram,et al.  Effect of fexofenadine on eosinophil-induced changes in epithelial permeability and cytokine release from nasal epithelial cells of patients with seasonal allergic rhinitis. , 1998, The Journal of allergy and clinical immunology.

[22]  R. Slavin.  Complications of allergic rhinitis: implications for sinusitis and asthma. , 1998, The Journal of allergy and clinical immunology.

[23]  H. A. Serra,et al.  Loratadine-pseudoephedrine in children with allergic rhinitis, a controlled double-blind trial. , 1998, British journal of clinical pharmacology.

[24]  A. Harris,et al.  Efficacy and safety of loratadine plus pseudoephedrine in patients with seasonal allergic rhinitis and mild asthma. , 1997, The Journal of allergy and clinical immunology.

[25]  G. Canonica,et al.  Cetirizine treatment of rhinitis in children with pollen allergy: evidence of its antiallergic activity , 1997, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology.

[26]  M. Bähre,et al.  Evaluation of the drug monitoring programme of azelastine hydrochloride nasal spray in the treatment of allergic rhinitis in children under 13 years of age. , 1997, Arzneimittel-Forschung.

[27]  W. Lumry,et al.  Once-Daily Cetirizine Effective in the Treatment of Seasonal Allergic Rhinitis in Children Aged 6 to 1 Years: A Randomized, Double-Blind, Placebo-Controlled Study , 1997, Clinical pediatrics.

[28]  J. Bergman,et al.  The clinical pharmacology of fexofenadine in children. , 1996, The Journal of allergy and clinical immunology.

[29]  Simons Fe.  Learning impairment and allergic rhinitis. , 1996 .

[30]  E. Meltzer,et al.  Histamine levels and nasal cytology in children with chronic otitis media and rhinitis. , 1995, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[31]  E. Meltzer.  An overview of current pharmacotherapy in perennial rhinitis. , 1995, The Journal of allergy and clinical immunology.

[32]  F. Simons,et al.  Nasal patency in children with allergic rhinitis: correlation of objective and subjective assessments. , 1995, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[33]  M. Masi,et al.  A placebo‐controlled trial of cetirizine in seasonal allergic rhino‐conjunctivitis in children aged 6 to 12 years , 1993, Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology.

[34]  Y. Baelde,et al.  Cetirizine in Children with Chronic Allergic Rhinitis , 1992 .

[35]  J. O'hanlon,et al.  Seasonal allergic rhinitis and antihistamine effects on children's learning , 1992, European Neuropsychopharmacology.

[36]  G. Shapiro.  The role of nasal airway obstruction in sinus disease and facial development. , 1988, The Journal of allergy and clinical immunology.

[37]  K. Simons,et al.  Suppression of the early and late cutaneous allergic responses using fexofenadine and montelukast. , 2001, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[38]  H. Nelson,et al.  The importance of allergens in the development of asthma and the persistence of symptoms. , 2001, Disease-a-month : DM.

[39]  D. Malone,et al.  A cost of illness study of allergic rhinitis in the United States. , 1997, The Journal of allergy and clinical immunology.

[40]  David Skoner.  Control of Allergic Rhinitis with Antihistamines May Prevent the Onset or Recurrence of Otitis Media , 1997 .

[41]  D. Tinkelman,et al.  Treatment of Seasonal Allergic Rhinitis in Children with Cetirizine or Chlorpheniramine: A Multicenter Study , 1996 .