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Oral Montelukast Compared with Inhaled Salmeterol To Prevent Exercise-Induced Bronchoconstriction: A Randomized, Double-Blind Trial

Jonathan M. Edelman, MD; Jennifer A. Turpin, MS; Edwin A. Bronsky, MD; Jay Grossman, MD; James P. Kemp, MD; Asma F. Ghannam, RN, MSN; Paul T. DeLucca, MS; Glenn J. Gormley, MD, PhD; David S. Pearlman, MD, Exercise Study Group*
[+] Article and Author Information

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.


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@merck.com. For reprint orders in quantities exceeding 100, please contact the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@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.


Ann Intern Med. 2000;132(2):97-104. doi:10.7326/0003-4819-132-2-200001180-00002
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Exercise-induced bronchoconstriction is common in patients with chronic asthma (1). Airway cooling or desiccation during exercise may trigger activation of mast cells and release of such mediators as histamine and cysteinyl leukotrienes, resulting in bronchospasm (12). Cysteinyl leukotrienes (LTC4, LTD4, and LTE4), synthesized from arachidonic acid through the 5-lipoxygenase pathway, are potent bronchoconstrictors, with an effect greater than 1000 times that of histamine (35). Several researchers have demonstrated an increase in urinary concentrations of LTE4 after exercise (67). Prophylaxis against exercise-induced bronchoconstriction with inhaled mast cell-stabilizing agents and short-acting β-agonists must be administered 15 to 30 minutes before exercise. The long-acting inhaled β-agonist salmeterol protects against exercise-induced bronchoconstriction for up to 12 hours, thus providing more flexibility in the dosing schedule for active patients with asthma (89). However, in some patients, tolerance to salmeterol develops with long-term use, and the level of bronchoprotection diminishes by 6 to 9 hours (1012).

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Figures

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Figure 1.
Study profile.1n

Of the 454 patients screened, 263 (58%) did not meet protocol inclusion criteria: Ninety-nine (38%) did not meet exercise challenge inclusion criteria (postexercise decrease in FEV < 20%), 102 (39%) did not meet pulmonary function inclusion criteria, 20 (8%) had disqualifying medical conditions or use of concomitant medications, and 42 (16%) were excluded for nonclinical reasons (they were lost to follow-up, withdrew consent, or had a scheduling conflict). Qualified patients ( = 191) were randomly allocated to receive montelukast (10 mg once every evening) or salmeterol (2 puffs [50 µg] twice daily). Ninety-three percent of the patients completed the study.

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Figure 2.
The FEV 1 after exercise in patients who received montelukast (top) and salmeterol (bottom).11circletrianglessquaresdiamonds

The mean response curves are shown for percentage change in FEV from prechallenge FEV at baseline ( s), days 1 to 3 ( ), week 4 ( ), and week 8 ( ) after study treatment.

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Figure 3.
Bronchoprotection over time.white barsstriped bars1top1AUC 0 middlebottomPPPP

Effect of treatment with montelukast ( ) and salmeterol ( ) on percentage change from prerandomization baseline values in maximal percentage decrease in FEV ( ), area under the FEV -time curve ( -60 min) ( ), and time to recovery ( ). Data are presented as the median ± SE. * = 0.010; † = 0.015; ‡ = 0.002; § ≤ 0.001.

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Figure 4.
Distribution of maximal percentage decrease in FEV 1 .1white barsstriped barsP

The percentage of patients achieving <10%, ≥ 10% to 20%, ≥ 20% to 40%, and ≥ 40% maximal decrease in FEV from pre-exercise baseline values after 8 weeks of montelukast therapy ( ) or salmeterol therapy ( ). = 0.028 for overall distribution of maximal percentage decrease at week 8 between the montelukast group and the salmeterol group.

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Summary for Patients

A Comparison of Two Drugs to Treat Exercise-Induced Asthma

The summary below is from the full report titled “Oral Montelukast Compared with Inhaled Salmeterol To Prevent Exercise-Induced Bronchoconstriction. A Randomized, Double-Blind Trial.” It is in the 18 January 1999 issue of Annals of Internal Medicine (volume 131, pages 97-104). The authors are J.M. Edelman, J.A. Turpin, E.A. Bronsky, J. Grossman, J.P. Kemp, A.F. Ghannam, P.T. DeLucca, G.J. Gormley, and D.S. Pearlman, for the Exercise Study Group.

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