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* From the Jefferson Medical College (Dr. Fish), Philadelphia, PA; Brigham & Women’s Hospital (Dr. Israel), Boston, MA; Vanderbilt Medical Center (Dr. Murray), Nashville, TN; and Glaxo Wellcome Inc (Mss. Emmett and Boone, Mr. Yancey, and Dr. Rickard), Research Triangle Park, NC.
Correspondence to: James E. Fish, MD, FCCP, Jefferson Medical College, 1025 Walnut St, Suite 805, Philadelphia, PA 19107-5083; e-mail: james.e.fish{at}mail.tju.edu
Study objectives: Comparison of inhaled salmeterol powder vs oral montelukast treatment in patients with persistent asthma who remained symptomatic while receiving inhaled corticosteroids.
Design: Randomized, double-blind, double-dummy, parallel-group, multicenter trials of 12-week duration.
Setting: Outpatients in private and university-affiliated clinics.
Patients: Male and
female patients 
15 years of age with a diagnosis of asthma
(baseline FEV1 of 50 to 80% of predicted) and symptomatic
despite receiving inhaled corticosteroids.
Interventions: Inhaled salmeterol xinafoate powder, 50 µg bid, or oral montelukast, 10 mg qd.
Measurements and results: Treatment with salmeterol powder resulted in significantly greater improvements from baseline compared with montelukast for most efficacy measurements, including morning peak expiratory flow (35.0 L/min vs 21.7 L/min; p < 0.001), percentage of symptom-free days (24% vs 16%; p < 0.001), and the percentage of rescue-free days (27% vs 20%; p = 0.002). Total supplemental albuterol use was decreased significantly more in the salmeterol group compared with the montelukast group (- 1.90 puffs per day vs - 1.66 puffs per day; p = 0.004) and nighttime awakenings per week decreased significantly more with salmeterol than with montelukast (- 1.42 vs - 1.32; p = 0.015). Patients treated with inhaled salmeterol were significantly more satisfied with their treatment regimen and how well, how fast, and how long it worked than were patients who were treated with oral montelukast. The safety profiles for the two treatments were similar.
Conclusion: In patients with persistent asthma who remain symptomatic while receiving inhaled corticosteroids, adding inhaled salmeterol powder provided significantly greater improvement in lung function and asthma symptoms and was preferred by patients over oral montelukast.
Key Words: asthma • leukotriene receptor antagonist • long-acting ß2-agonist • montelukast • peak expiratory flow • salmeterol • xinafoate
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