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Published ahead of print on September 14, 2006, doi:10.1164/rccm.200601-112OC
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American Journal of Respiratory and Critical Care Medicine Vol 175. pp. 228-234, (2007)
© 2007 American Thoracic Society
doi: 10.1164/rccm.200601-112OC

Original Article

Combination Therapy with a Long-Acting beta-Agonist and a Leukotriene Antagonist in Moderate Asthma

Aaron Deykin, Michael E. Wechsler, Homer A. Boushey, Vernon M. Chinchilli, Susan J. Kunselman, Timothy J. Craig, Emily DiMango, John V. Fahy, Monica Kraft, Frank Leone, Stephen C. Lazarus, Robert F. Lemanske, Jr., Richard J. Martin, Gene R. Pesola, Stephen P. Peters, Christine A. Sorkness, Stanley J. Szefler, Elliot Israel for the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network

Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; University of California at San Francisco, San Francisco, California; Pennsylvania State University College of Medicine, Hershey, and Thomas Jefferson University, Philadelphia, Pennsylvania; Harlem Hospital Center and Columbia University, New York, New York; National Jewish Medical and Research Center, Denver, Colorado; University of Wisconsin, Madison, Madison, Wisconsin; and Wake Forest University Health Sciences Center, Winston-Salem, North Carolina

Correspondence and requests for reprints should be addressed to Aaron Deykin, M.D., Pulmonary Division Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115. E-mail: Aaron.Deykin{at}biogenidec.com

Rationale: Long-acting beta-agonists (LABAs) and inhaled corticosteroids administered together appear to be complementary in terms of effects on asthma control. The elements of asthma control achieved by LABAs (improved lung function) and leukotriene receptor antagonists (LTRAs; protection against exacerbations) may be complementary as well.

Objective: We sought to determine whether the combination of the LTRA montelukast and the LABA salmeterol could provide an effective therapeutic strategy for asthma.

Methods and Measurements: In a randomized, placebo-controlled, crossover study of 192 subjects with moderate asthma, we compared the clinical efficacy of regular treatment over 14 weeks with the combination of montelukast and salmeterol to that with the combination of beclomethasone and salmeterol in moderate asthma. The primary efficacy outcome was time to treatment failure.

Main Results: Three months after the randomization of the last subject, the Data and Safety Monitoring Board determined that the primary research question had been answered and terminated the trial. The combination of montelukast and salmeterol was inferior to the combination of beclomethasone and salmeterol as judged by protection against asthma treatment failures (p = 0.0008), lung function (26 L/min difference in A.M. peak expiratory flow rate, p = 0.011), asthma control score (0.22 difference in Asthma Control Questionnaire score, p = 0.038), and markers of inflammation and airway reactivity.

Conclusions: Patients with moderate asthma similar to those we studied should not substitute the combination of an LTRA and an LABA for the combination of inhaled corticosteroid and an LABA.

Key Words: combination therapy • leukotriene • beta-agonists • inhaled corticosteroids


AT A GLANCE COMMENTARY

Scientific Knowledge on the Subject
Previous studies in asthma suggest that the most robust clinical effects of long-acting beta-agonists (improved lung function) are distinct from those of the leukotriene receptor antagonists (protection against exacerbations). The efficacy of combination therapy with these agents, as compared with the usual combination therapy with a long-acting beta-agonist and an inhaled corticosteroid, is not known.

What This Study Adds to the Field
In patients with moderate asthma, the combination of a leukotriene receptor antagonist and a long-acting beta-agonist was inferior to the combination of an inhaled corticosteroid and a long-acting beta-agonist as judged by protection against asthma treatment failures, lung function, and markers of inflammation and airway reactivity. Patients similar to those we studied should not substitute the combination of a leukotriene receptor antagonist and a long-acting beta-agonist for the combination of an inhaled corticosteroid and a long-acting beta-agonist.

 



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