Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: a randomized clinical trial

J Allergy Clin Immunol. 2001 Mar;107(3):461-8. doi: 10.1067/mai.2001.114657.


Background: Both inhaled corticosteroids and leukotriene modifiers are used in the maintenance treatment of persistent asthma.

Objective: The goal was to compare the efficacy and safety of low-dose fluticasone propionate (FP) and montelukast as first-line maintenance therapy in symptomatic patients by using short-acting beta2-agonists alone to treat persistent asthma.

Methods: In this multicenter, randomized, double-blind, double-dummy, parallel-group study, 533 patients (>15 years old) with persistent asthma who remained symptomatic while taking short-acting beta2-agonists alone were treated with FP (88 microg [2 puffs of 44 microg] twice daily) or montelukast (10 mg once daily) for 24 weeks.

Results: Compared with treatment with montelukast, treatment with FP resulted in significantly greater improvements at endpoint in morning predose FEV(1) (22.9% vs 14.5%, P <.001), forced midexpiratory flow (0.66 vs 0.41 L/sec, P <.001), forced vital capacity (0.42 vs 0.29 L, P =.002), morning peak expiratory flow (PEF) (68.5 vs 34.1 L/min, P <.001), and evening PEF (53.9 vs 28.7 L/min, P <.001). Similar improvements in PEF were observed in patients with milder asthma (>70%-80% predicted FEV(1)). At endpoint, FP was more effective than montelukast at decreasing rescue albuterol use (3.1 puffs/day vs 2.3 puffs/day, P <.001), asthma symptom scores (-0.85 [48.6% decrease] vs -0.60 [30.5%], P <.001), and nighttime awakenings due to asthma (-0.64 awakenings/night [62% decrease] vs -0.48 awakenings/night [47.5%], P =.023), and FP increased the percentage of symptom-free days (32.0% vs 18.4% of days, P <.001) compared with montelukast. The adverse event and asthma exacerbation profiles for FP and montelukast were similar.

Conclusions: Low-dose FP is more effective than montelukast as first-line maintenance therapy for patients with persistent asthma who are undertreated and remain symptomatic while taking short-acting beta2-agonists alone.

Publication types

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

MeSH terms

  • Acetates / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / administration & dosage*
  • Anti-Asthmatic Agents / therapeutic use
  • Anti-Inflammatory Agents / administration & dosage
  • Asthma / drug therapy*
  • Cyclopropanes
  • Dose-Response Relationship, Drug
  • Female
  • Fluticasone
  • Humans
  • Male
  • Middle Aged
  • Quinolines / therapeutic use*
  • Sulfides


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