Efficacy and Safety of Cetirizine and Oxatomide in Young Children With Perennial Allergic Rhinitis: A 10-Day, Multicenter, Double-Blinded, Randomized, Parallel-Group Study

Authors:
  • FBFernando M. DE Benedictis
    Fernando M. DE Benedictis
  • NFNicola Forenza
    Nicola Forenza
  • LALucio Armenio
    Lucio Armenio
  • ABAttilio L. Boner
    Attilio L. Boner
  • PGPier Luigi Giorgi
    Pier Luigi Giorgi
  • MGMichele Miraglia DEL Giudice
    Michele Miraglia DEL Giudice
  • GMGuido Morgese
    Guido Morgese
  • IGIvana Grimaldi
    Ivana Grimaldi
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Abstract
This study was designed to compare the efficacy and safety of cetirizine and oxatomide in young children who have perennial allergic rhinitis. During this 10-day multicenter, doubleblinded, randomized, parallel-group study, 102 children aged 2-6 years received orally administered cetirizine (5 mg once daily) or oxatomide (12.5 mg twice daily). Sneezing, rhinorrea, nasal obstruction, nasal itching, and ocular itching were evaluated by means of symptom scores by investigators and, on daily record cards, by parents. Tolerability was assessed on the basis of adverse events and on the results of routine laboratory tests performed before and after treatment. Compared to baseline both cetirizine and oxatomide improved symptoms significantly. No significant difference in efficacy was found between the two drugs. Both products were well tolerated. Mild sedation was only occasionally reported and no patient withdrew from treatment because of an adverse event. In clinical practice cetirizine may be preferable because of its long action and convenient single daily dose.

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