Anti-inflammatory effects of montelukast in mild cystic fibrosis

Ann Allergy Asthma Immunol. 2002 Dec;89(6):599-605. doi: 10.1016/S1081-1206(10)62108-4.


Background: Immune-mediated inflammation contributes to progressive pulmonary damage in cystic fibrosis (CF). Sputum cysteinyl leukotriene levels, eosinophil cationic protein (ECP), and interleukin-8 (IL-8) are significantly related to disease severity.

Objective: The aim of this study was to evaluate the anti-inflammatory and clinical effects of the cysteinyl leukotriene receptor antagonist montelukast in children with CF.

Methods: A double-blind, randomized, crossover design was used. Patients received montelukast (6 to < or = 14 years, 5 mg; > 14 years, 10 mg) or placebo as a once-daily tablet for 21 days and then, after a washout period of at least 4 weeks, crossed over to receive the alternative treatment. Blood and native nasal fluid were taken on days 1 and 21 of each treatment block, and WBC count, ECP, and IL-8 were analyzed using a chemiluminescent immunometric assay.

Results: Sixteen CF patients (10 boys, 6 girls; age, 5 to 18 years, median 9.5 years) completed the trial. There was a significant (P < or = 0.02) reduction of serum ECP (median reduction: montelukast 7.7 microg/L vs placebo 0.15 microg/L) and eosinophils (P < or = 0.027; median reduction: montelukast 85/microL vs placebo 0/microL). There was no significant change in nasal ECP, IL-8, or serum IL-8 after a 21-day course of montelukast. Clinical symptom scores did not change significantly.

Conclusions: Montelukast reduces eosinophilic inflammation in CF patients. Multicenter trials providing more patients to create more data to prove the hypothesis that montelukast is an effective tool to cut down disease severity in CF patients are needed.

Publication types

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

MeSH terms

  • Acetates / therapeutic use*
  • Adolescent
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Blood Proteins / analysis
  • Child
  • Cross-Over Studies
  • Cyclopropanes
  • Cystic Fibrosis / drug therapy*
  • Cystic Fibrosis / pathology
  • Double-Blind Method
  • Eosinophil Granule Proteins
  • Eosinophilia / drug therapy
  • Eosinophilia / etiology
  • Humans
  • Inflammation
  • Interleukin-8 / analysis
  • Leukocyte Count
  • Leukotriene Antagonists / therapeutic use*
  • Membrane Proteins*
  • Pilot Projects
  • Quinolines / therapeutic use*
  • Receptors, Leukotriene*
  • Respiratory Function Tests
  • Ribonucleases*
  • Sulfides
  • Treatment Outcome


  • Acetates
  • Anti-Inflammatory Agents, Non-Steroidal
  • Blood Proteins
  • Cyclopropanes
  • Eosinophil Granule Proteins
  • Interleukin-8
  • Leukotriene Antagonists
  • Membrane Proteins
  • Quinolines
  • Receptors, Leukotriene
  • Sulfides
  • cysteinyl leukotriene receptor 2
  • Ribonucleases
  • leukotriene D4 receptor
  • montelukast