Comparison of fluticasone propionate-salmeterol combination therapy and montelukast in patients who are symptomatic on short-acting beta(2)-agonists alone.
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 microg of fluticasone propionate and 50 microg 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 beta(2)-agonists alone. At end point, FSC resulted in significantly greater increases in morning predose FEV(1) (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 < or = 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.
Calhoun
W J
WJ
Asthma, Allergy, and Airway Research Center, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh Medical School, Pittsburgh, Pennsylvania 15213, USA. calhounwj@msx.upmc.edu
Nelson
H S
HS
Nathan
R A
RA
Pepsin
P J
PJ
Kalberg
C
C
Emmett
A
A
Rickard
K A
KA
Dorinsky
P
P
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000730:Androstadienes / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000627:therapeutic use*; D000068299:Salmeterol Xinafoate; D013440:Sulfides
D000085:Acetates; D000318:Adrenergic beta-Agonists; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; C093875:montelukast; D000420:Albuterol