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Published ahead of print on September 14, 2006, doi:10.1164/rccm.200601-112OC

Am. J. Respir. Crit. Care Med., Volume 175, Number 3, February 2007, 228-234

A more recent version of this article appeared on February 1, 2007
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Submitted on January 25, 2006
Accepted on September 8, 2006

Combination Therapy with a Long-acting {beta}-Agonist and a Leukotriene Antagonist in Moderate Asthma

Aaron Deykin1*, Michael E Wechsler1, Homer A Boushey2, Vernon M Chinchilli3, Susan J Kunselman3, Timothy J Craig3, Emily DiMango4, John V Fahy2, Monica Kraft5, Frank Leone6, Stephen C Lazarus2, Robert F Lemanske7, Richard J Martin5, Gene R Pesola4, Stephen P Peters8, Christine A Sorkness7, Stanley J Szefler5, and Elliot Israel1

1 Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA, 2 University of California at San Francisco, San Francisco, CA, USA, 3 Pennsylvania State University College of Medicine, Hershey, PA, USA, 4 Harlem Hospital Center and Columbia University, New York, NY, USA, 5 National Jewish Medical and Research Center, Denver, CO, USA, 6 Thomas Jefferson University, Philadelphia, PA, USA, 7 University of Wisconsin, Madison, WI, USA, 8 Wake Forest University Health Sciences Center, Winston-Salem, NC, USA

* To whom correspondence should be addressed. E-mail: adeykin{at}partners.org.

Rationale: Long-acting beta-agonists (LABA) and inhaled corticosteroids (ICS) administered together appear to be complementary in terms of effects on asthma control. The elements of asthma control achieved by LABA (improved lung function) and leukotriene receptor antagonists (LTRA, 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: In a randomized, placebo-controlled, cross-over 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. Measurements and Main Results: Three months following the randomization of the last subject, 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 liter per minute difference in AM peak expiratory flow rate, p=0.011) and asthma control score (0.22 difference in ACQ 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 a LABA for the combination of ICS and LABA. www.clinicaltrials.gov NCT00000577
Key words: Asthma Therapy, Leukotriene Antagonists, Beta-Agonists, Combination Therapy




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