Effect of the addition of montelukast to fluticasone propionate for the treatment of perennial allergic rhinitis

Ann Allergy Asthma Immunol. 2010 Aug;105(2):155-61. doi: 10.1016/j.anai.2010.05.017. Epub 2010 Jun 19.


Background: Guidelines for the treatment of patients with allergic rhinitis (AR) recommend intranasal corticosteroids as first-line therapy. In clinical trials, however, only 50% of patients obtain excellent symptom control.

Objective: To evaluate the effectiveness of montelukast add-on therapy in patients with perennial AR (PAR) who have incomplete relief of symptoms after 2 weeks of treatment with intranasal fluticasone propionate.

Methods: We performed a 4-week parallel, randomized, double-blind, placebo-controlled trial. One hundred two patients with a history of PAR and a positive skin test reaction to perennial allergens were recruited. They completed the Rhinitis Quality of Life Questionnaire (RQLQ) and were given intranasal fluticasone propionate, 200 microg daily. They were asked to complete symptom diary cards twice daily. After 2 weeks of treatment, patients with a mean total nasal symptom score of at least 4 during the past week (n = 54) were randomized to receive either montelukast (n = 28) or placebo (n = 26) in addition to the continued use of fluticasone propionate. At weeks 3 and 4, the RQLQ was completed again and symptom diary cards were collected.

Results: Compared with baseline, there were significant improvements in almost all domains of the RQLQ while taking fluticasone propionate (P < .001). A similar trend was observed for nasal symptom scores. After randomization to receive montelukast or placebo, there were no significant differences in RQLQ measures or nasal symptom scores between the groups during the 2 weeks of combination therapy.

Conclusion: The addition of montelukast to an intranasal corticosteroid for the treatment of PAR with residual symptoms is no more effective than is placebo.

Trial registration: ClinicalTrials.gov NCT00119015.

Publication types

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

MeSH terms

  • Acetates / administration & dosage*
  • Acetates / adverse effects
  • Adolescent
  • Adult
  • Androstadienes / therapeutic use
  • Anti-Inflammatory Agents / therapeutic use
  • Chemotherapy, Adjuvant
  • Cyclopropanes
  • Feasibility Studies
  • Female
  • Fluticasone
  • Humans
  • Leukotriene Antagonists / administration & dosage*
  • Leukotriene Antagonists / adverse effects
  • Male
  • Middle Aged
  • Quality of Life
  • Quinolines / administration & dosage*
  • Quinolines / adverse effects
  • Rhinitis, Allergic, Perennial / diagnosis
  • Rhinitis, Allergic, Perennial / drug therapy*
  • Rhinitis, Allergic, Perennial / physiopathology
  • Skin Tests
  • Sulfides
  • Surveys and Questionnaires
  • Treatment Outcome


  • Acetates
  • Androstadienes
  • Anti-Inflammatory Agents
  • Cyclopropanes
  • Leukotriene Antagonists
  • Quinolines
  • Sulfides
  • Fluticasone
  • montelukast

Associated data

  • ClinicalTrials.gov/NCT00119015