title: Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis.
abstract: 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.
authors.affiliation: Section of Otolaryngology-Head and Neck Surgery, The Pritzker School of Medicine, The University of Chicago, Chicago, Illinois 60637, USA.
authors.forename: Rizwan
authors.initials: R
authors.lastname: Moinuddin
authors.forename: Marcy
authors.initials: M
authors.lastname: deTineo
authors.forename: Barbara
authors.initials: B
authors.lastname: Maleckar
authors.forename: Robert M
authors.initials: RM
authors.lastname: Naclerio
authors.forename: Fuad M
authors.initials: FM
authors.lastname: Baroody
mesh_terms: D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D031164:Ambrosia / Q000009:adverse effects*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004809:Ephedrine / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D017336:Loratadine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000209:etiology; D013440:Sulfides; D011795:Surveys and Questionnaires; D016593:Terfenadine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000085:Acetates; D018926:Anti-Allergic Agents; D003521:Cyclopropanes; D039563:Histamine H1 Antagonists, Non-Sedating; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D014662:Vasoconstrictor Agents; D017336:Loratadine; D016593:Terfenadine; C093230:fexofenadine; D004809:Ephedrine; C093875:montelukast