@article {Kaiser:1 August 2001:1173-2563:571, author = "Kaiser H.B.", author = "Rooklin A.", author = "Spangler D.", author = "Capano D.", title = "Efficacy of Loratadine Compared with Fexofenadine or Placebo for the Treatment of Seasonal Allergic Rhinitis", journal = "Clinical Drug Investigation", volume = "21", year = "1 August 2001", 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.", pages = "571-578(8)", url = "http://www.ingentaconnect.com/content/adis/cdi/2001/00000021/00000008/art00006" }