Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis

Ann Allergy Asthma Immunol. 2004 Jan;92(1):73-9. doi: 10.1016/S1081-1206(10)61713-9.


Background: Antihistamine-decongestant combinations are used routinely for the treatment of seasonal allergic rhinitis. Recently, the combination of an antihistamine and a leukotriene receptor antagonist has been shown to be efficacious.

Objective: To compare the 2 combinations in the treatment of seasonal allergic rhinitis.

Methods: This was a randomized, double-blind, double-dummy, parallel study in which patients with seasonal allergic rhinitis received either fexofenadine, 60 mg, and pseudoephedrine, 120 mg, twice daily, or loratadine, 10 mg, and montelukast, 10 mg, once daily, for 2 weeks. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at the beginning and end of the study. Patients recorded nasal symptoms and measured nasal peak inspiratory flow (NPIF) twice daily. Baseline measurements were obtained before initiation of treatment.

Results: Compared with baseline, both treatments resulted in statistically and clinically meaningful reductions of overall and individual RQLQ domain scores (P < .01) except for the sleep domain, for which only loratadine-montelukast led to significant improvement. There was a significant reduction in total symptoms (P < or = .05) compared with baseline on most treatment days in patients receiving both combinations. When the change from baseline was analyzed, there were no statistically significant differences in total symptoms between fexofenadine-pseudoephedrine and loratadine-montelukast (median, -28.5 vs -22.5; P = .33). There was a significant improvement in NPIF from baseline on all treatment days in both groups (P < .05), with no significant difference between treatments.

Conclusions: Fexofenadine-pseudoephedrine and loratadine-montelukast have comparable efficacy in improving symptoms, RQLQ scores, and nasal obstruction in seasonal allergic rhinitis. The lack of improvement in sleep in the fexofenadine-pseudoephedrine group is probably related to insomnia, a known adverse effect of pseudoephedrine.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acetates / administration & dosage
  • Acetates / therapeutic use*
  • Adolescent
  • Adult
  • Ambrosia / adverse effects*
  • Anti-Allergic Agents / administration & dosage
  • Anti-Allergic Agents / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Ephedrine / administration & dosage
  • Ephedrine / therapeutic use*
  • Female
  • Histamine H1 Antagonists, Non-Sedating / administration & dosage
  • Histamine H1 Antagonists, Non-Sedating / therapeutic use
  • Humans
  • Leukotriene Antagonists / administration & dosage
  • Leukotriene Antagonists / therapeutic use
  • Loratadine / administration & dosage
  • Loratadine / therapeutic use*
  • Male
  • Middle Aged
  • Quality of Life
  • Quinolines / administration & dosage
  • Quinolines / therapeutic use*
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Rhinitis, Allergic, Seasonal / etiology
  • Surveys and Questionnaires
  • Terfenadine / administration & dosage
  • Terfenadine / analogs & derivatives*
  • Terfenadine / therapeutic use*
  • Treatment Outcome
  • Vasoconstrictor Agents / administration & dosage
  • Vasoconstrictor Agents / therapeutic use


  • Acetates
  • Anti-Allergic Agents
  • Histamine H1 Antagonists, Non-Sedating
  • Leukotriene Antagonists
  • Quinolines
  • Vasoconstrictor Agents
  • Loratadine
  • Terfenadine
  • fexofenadine
  • Ephedrine
  • montelukast