Combination therapy with a long-acting β-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, Richard J. Martin, Gene R. Pesola, Stephen P. Peters, Christine A. Sorkness, Stanley J. Szefler, Elliot Israel

Research output: Contribution to journalArticle

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Abstract

Rationale: Long-acting β-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.

Original languageEnglish (US)
Pages (from-to)228-234
Number of pages7
JournalAmerican journal of respiratory and critical care medicine
Volume175
Issue number3
DOIs
StatePublished - Feb 1 2007

Fingerprint

Leukotriene Antagonists
montelukast
Asthma
Beclomethasone
Therapeutics
Treatment Failure
Adrenal Cortex Hormones
Clinical Trials Data Monitoring Committees
Peak Expiratory Flow Rate
Lung
Random Allocation
Cross-Over Studies
Placebos
Salmeterol Xinafoate
Inflammation

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

Cite this

Deykin, Aaron ; Wechsler, Michael E. ; Boushey, Homer A. ; Chinchilli, Vernon M. ; Kunselman, Susan J. ; Craig, Timothy J. ; DiMango, Emily ; Fahy, John V. ; Kraft, Monica ; Leone, Frank ; Lazarus, Stephen C. ; Lemanske, Robert F. ; Martin, Richard J. ; Pesola, Gene R. ; Peters, Stephen P. ; Sorkness, Christine A. ; Szefler, Stanley J. ; Israel, Elliot. / Combination therapy with a long-acting β-agonist and a leukotriene antagonist in moderate asthma. In: American journal of respiratory and critical care medicine. 2007 ; Vol. 175, No. 3. pp. 228-234.
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abstract = "Rationale: Long-acting β-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.",
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Deykin, A, Wechsler, ME, Boushey, HA, Chinchilli, VM, Kunselman, SJ, Craig, TJ, DiMango, E, Fahy, JV, Kraft, M, Leone, F, Lazarus, SC, Lemanske, RF, Martin, RJ, Pesola, GR, Peters, SP, Sorkness, CA, Szefler, SJ & Israel, E 2007, 'Combination therapy with a long-acting β-agonist and a leukotriene antagonist in moderate asthma', American journal of respiratory and critical care medicine, vol. 175, no. 3, pp. 228-234. https://doi.org/10.1164/rccm.200601-112OC

Combination therapy with a long-acting β-agonist and a leukotriene antagonist in moderate asthma. / Deykin, Aaron; Wechsler, Michael E.; Boushey, Homer A.; Chinchilli, Vernon M.; Kunselman, Susan J.; Craig, Timothy J.; DiMango, Emily; Fahy, John V.; Kraft, Monica; Leone, Frank; Lazarus, Stephen C.; Lemanske, Robert F.; Martin, Richard J.; Pesola, Gene R.; Peters, Stephen P.; Sorkness, Christine A.; Szefler, Stanley J.; Israel, Elliot.

In: American journal of respiratory and critical care medicine, Vol. 175, No. 3, 01.02.2007, p. 228-234.

Research output: Contribution to journalArticle

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T1 - Combination therapy with a long-acting β-agonist and a leukotriene antagonist in moderate asthma

AU - Deykin, Aaron

AU - Wechsler, Michael E.

AU - Boushey, Homer A.

AU - Chinchilli, Vernon M.

AU - Kunselman, Susan J.

AU - Craig, Timothy J.

AU - DiMango, Emily

AU - Fahy, John V.

AU - Kraft, Monica

AU - Leone, Frank

AU - Lazarus, Stephen C.

AU - Lemanske, Robert F.

AU - Martin, Richard J.

AU - Pesola, Gene R.

AU - Peters, Stephen P.

AU - Sorkness, Christine A.

AU - Szefler, Stanley J.

AU - Israel, Elliot

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Y1 - 2007/2/1

N2 - Rationale: Long-acting β-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.

AB - Rationale: Long-acting β-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.

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