Oral Montelukast Compared with Inhaled Salmeterol To Prevent Exercise-Induced Bronchoconstriction

A Randomized, Double-Blind Trial

  1. Jonathan M. Edelman, MD;
  2. Jennifer A. Turpin, MS;
  3. Edwin A. Bronsky, MD;
  4. Jay Grossman, MD;
  5. James P. Kemp, MD;
  6. Asma F. Ghannam, RN, MSN;
  7. Paul T. DeLucca, MS;
  8. Glenn J. Gormley, MD, PhD;
  9. David S. Pearlman, MD; and
  10. for the Exercise Study Group*
  1. From Merck & Co., Inc., West Point, Pennsylvania; Intermountain Clinical Research, Salt Lake City, Utah; VIVRA Research Partners, Tucson, Arizona; Allergy and Asthma Medical Group and Research Center, San Diego, California; and Colorado Allergy and Asthma Clinic, P.C., Aurora, Colorado.

    Abstract

    Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction.

    Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or montelukast on exercise-induced bronchoconstriction in adults with asthma.

    Design: 8-week multicenter, randomized, double-blind study.

    Setting: 17 asthma treatment centers in the United States.

    Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction.

    Intervention: Qualified patients were randomly assigned to double-blind treatment with montelukast (10 mg once in the evening) or salmeterol (50 µg [2 puffs] twice daily).

    Measurements: Changes in pre-exercise and post-exercise challenge values; percentage inhibition in the maximal percentage decrease in FEV1; the area above the FEV1-time curve; and time to recovery of FEV1 at days 1 to 3, week 4, and week 8 of treatment.

    Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV1 were seen with both therapies. Sustained improvement occurred in the montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV1 was 57.2% in the montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV1 of less than 20%.

    Conclusions: The bronchoprotective effect of montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance.

    *For members of the Exercise Study Group, see the Appendix.

    Article and Author Information

    • Acknowledgments: The authors thank Drs. Theodore Reiss, Beth Seidenberg, and Reynold Spector of Merck Research Laboratories for their contribution to the implementation and completion of this study. They also thank Melissa Mergen for assistance with the manuscript preparation.

    • Grant Support: By Merck & Co., Inc., Whitehouse Station, New Jersey.

    • Requests for Reprints: Jonathan M. Edelman, MD, Merck & Co., Inc., Box 4, HM-220, West Point, PA 19486; e-mail, edelmanj{at}merck.com. For reprint orders in quantities exceeding 100, please contact the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints{at}mail.acponline.org.

    • Current Author Addresses: Dr. Edelman, Ms. Turpin, Ms. Ghannam, Mr. DeLucca, and Dr. Gormley: Merck & Co., Inc., Box 4, HM-220, West Point, PA 19486.

    • Dr. Bronsky: Intermountain Clinical Research, 150 South 1000 East, Salt Lake City, UT 84102.

    • Dr. Grossman: VIVRA Research Partners, 698 East Wetmore Road, Suite 100, Tucson, AZ 85705.

    • Dr. Kemp: Allergy and Asthma Medical Group and Research Center, 9610 Granite Ridge Drive, Suite B, San Diego, CA 92123.

    • Dr. Pearlman: Colorado Allergy and Asthma Centers, 1450 South Havana Street, Aurora, CO 80012.

    • Author Contributions: Conception and design: J.M. Edelman, J.A. Turpin, P.T. DeLucca.

    • Analysis and interpretation of the data: J.M. Edelman, J.A. Turpin, A.F. Ghannam, P.T. DeLucca, G.J. Gormley, D.S. Pearlman.

    • Drafting of the article: J.M. Edelman, J.A. Turpin, E.A. Bronsky, J. Grossman, J.P. Kemp, A.F. Ghannam, G.J. Gormley.

    • Critical revision of the article for important intellectual content: J.M. Edelman, E.A. Bronsky, J. Grossman, A.F. Ghannam, P.T. DeLucca, G.J. Gormley, D.S. Pearlman.

    • Final approval of the article: J.M. Edelman, E.A. Bronsky, J. Grossman, J.P. Kemp, A.F. Ghannam, P.T. DeLucca, G.J. Gormley, D.S. Pearlman.

    • Provision of study material or patients: E.A. Bronsky, J. Grossman, J.P. Kemp, D.S. Pearlman.

    • Statistical expertise: P.T. DeLucca.

    • Obtaining of funding: J.M. Edelman.

    • Administrative, technical, or logistic support: J.M. Edelman, J.A. Turpin, E.A. Bronsky, J. Grossman, J.P. Kemp, A.F. Ghannam, P.T. DeLucca, D.S. Pearlman.

    • Collection and assembly of data: J.M. Edelman, J.A. Turpin, E.A. Bronsky, J. Grossman, J.P. Kemp, A.F. Ghannam, P.T. DeLucca, D.S. Pearlman.

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    1. Ann Intern Med January 18, 2000 vol. 132 no. 2 97-104
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