Comparison of fluticasone propionate-salmeterol combination therapy and montelukast in patients who are symptomatic on short-acting β2-agonists alone

William J. Calhoun, Harold S. Nelson, Robert A. Nathan, Pamela J. Pepsin, Chris Kalberg, Amanda Emmett, Kathleen A. Rickard, Paul Dorinsky

Research output: Contribution to journalArticlepeer-review

49 Scopus citations


The objective of this study was to determine whether initial maintenance therapy for the treatment of inflammation and bronchoconstriction associated with persistent asthma is more effective with a combination product (100 μg of fluticasone propionate and 50 μg of salmeterol [FSC]) administered twice daily through the Diskus device (GlaxoWellcome, Research Triangle Park, NC) or with montelukast at 10 mg once daily. A 12-wk, randomized, double-blind, double-dummy, multicenter study was conducted with 423 patients 15 yr of age and older with asthma and who were symptomatic while receiving short-acting β2-agonists alone. At end point, FSC resulted in significantly greater increases in morning predose FEV1 (0.54 ± 0.03 vs. 0.27 ± 0.03 L), morning peak expiratory flow (PEF) (89.9 ± 6.7 vs. 34.2 ± 4.7 L/min), evening PEF (69.9 ± 5.8 vs. 31.1 ± 4.5 L/min), the percentage of symptom-free days (48.9 ± 2.9 vs. 21.7 ± 2.5%), the percentage of rescue-free days (53.0 ± 2.8 vs. 26.2 ± 2.5%), and the percentage of nights with no awakenings (23.0 ± 2.5 vs. 15.5 ± 2.4%) compared with montelukast (p ≤ 0.001, all comparisons). FSC significantly reduced asthma symptom scores (-1.0 ± 0.1 vs. -0.6 ± 0.1), rescue albuterol use (-3.3 ± 0.2 vs. -1.9 ± 0.2 puffs/d), and the number of exacerbations (0 vs. 11) compared with montelukast (p < 0.001). Both treatments were well tolerated. In summary, treatment of the two main components of asthma (inflammation and bronchoconstriction) with fluticasone propionate and salmeterol in a combination product was a more effective initial maintenance treatment strategy than treatment with montelukast, a single-mediator antagonist.

Original languageEnglish (US)
Pages (from-to)759-763
Number of pages5
JournalAmerican Journal of Respiratory and Critical Care Medicine
Issue number5
StatePublished - Sep 1 2001
Externally publishedYes


  • Adrenal cortex hormones
  • Antiasthmatic agents
  • Asthma
  • Fluticasone propionate
  • Leukotriene antagonists
  • Long-acting β-agonists
  • Montelukast

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine


Dive into the research topics of 'Comparison of fluticasone propionate-salmeterol combination therapy and montelukast in patients who are symptomatic on short-acting β<sub>2</sub>-agonists alone'. Together they form a unique fingerprint.

Cite this