title: Desloratadine in combination with montelukast in the treatment of chronic urticaria: a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  Chronic urticaria (CU) is a common skin condition. It is frequently a disabling disease due to the persistency of clinical symptoms, the unpredictable course and negative influence on the quality of life.
  
  
  OBJECTIVE
  The aim of this study is to determine whether montelukast, a LTD4 receptor antagonist, plus desloratadine, is more efficacious than desloratadine alone in the treatment of chronic urticaria.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled study was conducted on 81 patients with a diagnosis of CU. A 1-week single-blind placebo run-in period (baseline) was followed by a 6-weeks double blind active treatment period. The patients were randomized to receive the following treatment once daily: (a) oral desloratadine (5 mg) plus placebo; (b) desloratadine (5 mg) plus montelukast (10 mg); (c) oral placebo alone. The study ended after another 1-week single-blind placebo washout period.
  
  
  RESULTS
  The evaluable population thus consisted of 76 patients. Both desloratadine alone and desloratadine plus montelukast administered once daily yielded improvements with respect to the baseline assessment as regards pruritus, number of separate episodes, size and number of weals, visual analogue score and patients' quality of life and with respect to the placebo group both in the active treatment period and in the run-out period. However, desloratadine plus montelukast was shown to improve the symptoms and patients' quality of life significantly more than desloratadine alone, although it did not have a significant effect on the number of urticarial episodes.
  
  
  CONCLUSIONS
  The combination of desloratadine plus montelukast is effective in the treatment of CU. It may therefore be a valid alternative in patients with relatively mild CU, in view of its efficacy and the lack of adverse events.
authors.affiliation: Department of Medical Clinic, Immunology and Infectious Diseases, Section of Allergy and Clinical Immunology, University of Bari, Bari, Italy. e.nettis@allergy.uniba.it
authors.forename: E
authors.initials: E
authors.lastname: Nettis
authors.forename: M C
authors.initials: MC
authors.lastname: Colanardi
authors.forename: M T
authors.initials: MT
authors.lastname: Paradiso
authors.forename: A
authors.initials: A
authors.lastname: Ferrannini
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage*; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage*; D017336:Loratadine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000188:drug therapy / Q000473:pathology; D011788:Quality of Life; D011804:Quinolines / Q000008:administration & dosage*; D012720:Severity of Illness Index; D013440:Sulfides; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D039563:Histamine H1 Antagonists, Non-Sedating; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; C121345:desloratadine; C093875:montelukast