IngentaConnect Efficacy of Loratadine Compared with Fexofenadine or Placebo for ...

Abstract:

Objective: To compare loratadine with fexofenadine and placebo in relieving symptoms of seasonal allergic rhinitis (SAR).

Design: A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study.

Study Participants: Participants were aged 12 to 60 years with spring/summer SAR and total symptom severity scores (TSS) of at least 8 (maximum score 15) on six of 14 pre-baseline time-points.

Interventions: Loratadine 10mg once daily, fexofenadine 60mg twice daily, or placebo for 7 days.

Main Outcome Measures and Results: The primary end-point was the reduction from baseline in am and pm reflective and instantaneous TSS at final assessment. Times to 25% and maximum reductions in am reflective TSS were also analysed. Drug administration with either loratadine or fexofenadine provided significant relief versus placebo: both agents provided similar reductions from baseline in am and pm reflective and instantaneous TSS at final assessment. Compared with fexofenadine, loratadine demonstrated a statistically greater percentage reduction in am and pm reflective TSS in four of the initial five assessments (p < 0.05 for day 1 pm, day 2 pm, and day 3 am and pm assessments), achieving significance versus fexofenadine as early as 12 hours following the first dose (day 1 pm). Median times to a 25% reduction and maximum reduction in am reflective TSS also occurred significantly earlier in patients receiving loratadine.

Conclusions: Compared with placebo, both loratadine and fexofenadine provided significant relief of the symptoms of SAR. At the first assessment following the first dose, however, loratadine demonstrated a significant reduction from baseline in TSS compared with fexofenadine. In addition, time-to-event analysis indicated that the reduction in symptoms occurred significantly earlier with loratadine.

Keywords: Adolescents; Fexofenadine, therapeutic use; Histamine H1 receptor antagonists, therapeutic use; Loratadine, therapeutic use; Seasonal allergic rhinitis, treatment

Document Type: Original article

Affiliations: 1: Clinical Research Institute, Minneapolis, Minnesota, USA 2: Allergy Research Associates, Media, Pennsylvania, USA 3: Atlanta Allergy & Immunology Research Foundation, Atlanta, Georgia, USA 4: Integrated Therapeutics Group, Inc., New Jersey, USA

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Efficacy of Loratadine Compared with Fexofenadine or Placebo for the Treatment of Seasonal Allergic Rhinitis