Efficacy of leukotriene receptor antagonist in chronic urticaria. A double-blind, placebo-controlled comparison of treatment with montelukast and cetirizine in patients with chronic urticaria with intolerance to food additive and/or acetylsalicylic acid

Clin Exp Allergy. 2001 Oct;31(10):1607-14. doi: 10.1046/j.1365-2222.2001.01189.x.


Background: The cause and pathogenesis of chronic urticaria are still poorly understood. IgE-independent reactions, are common in adult patients with chronic urticaria, who have daily spontaneous occurrence of weals. H(1)-receptor antagonists (antihistamines) are the major class of therapeutic agents used in the management of urticaria and angioedema. Nevertheless, chronic urticaria is often difficult to treat and may not be controlled by antihistamines alone. It has been postulated that mediators other than histamine, such as kinins, prostaglandin and leukotrienes, may be responsible for some of the symptoms in urticaria which are not controlled by antihistamines. In this study, which was randomized double-blind, placebo-controlled, we compare the clinical efficacy and safety of montelukast (MT) 10 mg given once a day and cetirizine (CET) 10 mg given once a day with placebo (PLA), in the treatment of patients with chronic urticaria who have positive challenge to acetylsalicylic acid (ASA) and/or food additives.

Patients and methods: A group of 51 patients, ranging in age from 15 to 71 years, with chronic urticaria and positive challenge to food additives and/or ASA, participated in this study for a period of 4 weeks, starting from a 3-day run-in. The assessment of the efficacy was based on scores of daily urticaria symptoms.

Results: MT significantly increased the percentage of symptom-free days for hive and itch. Analysis of frequency distribution of urticaria scores for each symptom gave similar results (MT vs. CET and MT vs. PLA, P < 0.001). The interference with sleep due to their skin condition was also lower in the group treated with MT (P < 0.001). In addition, the median number of days without the rescue medication was significantly higher in the MT group (24 days) than both the CET and the PLA groups (18 days, P < 0.001, and 20 days, P < 0.001, respectively). Finally, a low incidence of adverse events was observed in this study.

Conclusion: The results of this comparative study demonstrate that montelukast orally administered once a day is very effective for the treatment of cutaneous symptoms in patients with chronic urticaria due to food additives and/or ASA.

Publication types

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

MeSH terms

  • Acetates / antagonists & inhibitors*
  • Acetates / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Aspirin / adverse effects*
  • Cetirizine / antagonists & inhibitors*
  • Cetirizine / therapeutic use*
  • Chronic Disease
  • Cyclopropanes
  • Double-Blind Method
  • Female
  • Food Additives / adverse effects*
  • Food Hypersensitivity / complications
  • Food Hypersensitivity / etiology*
  • Histamine H1 Antagonists / therapeutic use*
  • Humans
  • Incidence
  • Italy
  • Leukotriene Antagonists / therapeutic use*
  • Male
  • Middle Aged
  • Quinolines / antagonists & inhibitors*
  • Quinolines / therapeutic use*
  • Sleep Stages / drug effects
  • Sulfides
  • Treatment Outcome
  • Urticaria / complications
  • Urticaria / drug therapy*


  • Acetates
  • Cyclopropanes
  • Food Additives
  • Histamine H1 Antagonists
  • Leukotriene Antagonists
  • Quinolines
  • Sulfides
  • montelukast
  • Aspirin
  • Cetirizine