Clinical Drug Investigation

, Volume 21, Issue 8, pp 571–578

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


  • Harold B. Kaiser
    • Clinical Research Institute
  • Anthony Rooklin
    • Allergy Research Associates
  • Dennis Spangler
    • Atlanta Allergy & Immunology Research Foundation
  • David Capano
    • Integrated Therapeutics Group, Inc.
Clinical Use

DOI: 10.2165/00044011-200121080-00006

Cite this article as:
Kaiser, H.B., Rooklin, A., Spangler, D. et al. Clin. Drug Investig. (2001) 21: 571. doi:10.2165/00044011-200121080-00006



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


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.


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.


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.

Copyright information

© Adis International Limited 2001