Am. J. Respir. Crit. Care Med., Volume 164, Number 5, September 2001, 759-763

Comparison of Fluticasone Propionate-Salmeterol Combination Therapy and Montelukast in Patients Who Are Symptomatic on Short-acting ₂-Agonists Alone

WILLIAM J. CALHOUN, HAROLD S. NELSON, ROBERT A. NATHAN, PAMELA J. PEPSIN, CHRIS KALBERG, AMANDA EMMETT, KATHLEEN A. RICKARD, and PAUL DORINSKY

Asthma, Allergy, and Airway Research Center, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh Medical School, Pittsburgh, Pennsylvania; National Jewish Medical and Research Center, Denver, Colorado; Asthma and Allergy Associates, PC, Colorado Springs, Colorado; and GlaxoWellcome, Research Triangle Park, North Carolina

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 ₂-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.

Keywords: adrenal cortex hormones; antiasthmatic agents; asthma; fluticasone propionate; leukotriene antagonists; long-acting ₂-agonists; montelukast

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