Fluticasone propionate nasal spray is superior to montelukast for allergic rhinitis while neither affects overall asthma control

Chest. 2005 Oct;128(4):1910-20. doi: 10.1378/chest.128.4.1910.


Background: Asthma and allergic rhinitis are both highly prevalent diseases and often coexist in patients.

Objective: To investigate the effect of rhinitis therapy on asthma outcomes in adult and adolescent patients with both seasonal allergic rhinitis (SAR) and persistent asthma.

Methods: A total of 863 patients (mean baseline FEV1 81% predicted) were randomized to receive open-label fluticasone propionate/salmeterol (FSC), 100/50 microg bid for 4 weeks, plus either blinded fluticasone propionate aqueous nasal spray (FPANS) 200 microg/d, montelukast 10 mg/d, or placebo. Patients kept daily records of peak expiratory flow (PEF), asthma, and rhinitis symptoms and rescue albuterol use.

Results: FPANS added to FSC resulted in superior outcomes for daytime total nasal symptom scores (D-TNSS) and individual daytime nasal specific symptoms (congestion, rhinorrhea, sneezing, and itching) compared with montelukast plus FSC and placebo plus FSC (p < or = 0.001). Montelukast plus FSC was superior to placebo plus FSC only for D-TNSS and itching and sneezing. Morning PEF, asthma symptoms, and rescue albuterol use improved significantly (p < or = 0.001) in all treatment groups, but improvements were comparable across the treatment groups.

Conclusion: In patients with persistent asthma treated with FSC, the addition of montelukast or FPANS for the treatment of SAR resulted in no additional improvements in overall asthma control compared with FSC alone. However, FPANS provided superior rhinitis control compared with montelukast. These data suggest that asthma and rhinitis should each be optimally treated.

Publication types

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

MeSH terms

  • Acetates / administration & dosage
  • Acetates / therapeutic use*
  • Administration, Inhalation
  • Adult
  • Androstadienes / administration & dosage
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use*
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / therapeutic use
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Cyclopropanes
  • Female
  • Fluticasone
  • Forced Expiratory Volume
  • Humans
  • Male
  • Patient Selection
  • Quinolines / administration & dosage
  • Quinolines / therapeutic use*
  • Reproducibility of Results
  • Respiratory Distress Syndrome / chemically induced
  • Respiratory Function Tests
  • Rhinitis, Allergic, Perennial / drug therapy*
  • Sleep Wake Disorders / chemically induced
  • Sulfides
  • Treatment Outcome
  • Wakefulness


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