Single-Dose Montelukast or Salmeterol as Protection Against Exercise-Induced Bronchoconstriction

Philip, George;Pearlman, David S.;Villarán, César;Legrand, Catherine;Reiss, Theodore;et.al.
(2007) Chest : the cardiopulmonary and critical care journal — Vol. 132, n° 3, p. 875-883 (2007)

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Authors
  • Philip, GeorgeMerck Research Laboratories
    Author
  • Pearlman, David S.Colorado and Asthma Centers
    Author
  • Villarán, CésarClinica Ricardo Palma
    Author
  • Author
  • Reiss, TheodoreMerck Research Laboratories
    Author
  • et. al.
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Abstract
ackground and objective: It has been previously established that montelukast provides protection against exercise-induced bronchoconstriction (EIB) after a single dose. The present objective was to assess the onset and duration of this protective action in a trial that included both positive and negative controls. Methods: A randomized, active-controlled and placebo-controlled, double-blind, double-dummy, three-way crossover study was conducted in 47 patients (age range, 15 to 44 years) in whom there was a 20 to 40% fall in FEV1 following exercise (ΔFEV1). In randomized sequence, patients received oral montelukast (10 mg), placebo, or inhaled salmeterol (50 μg) as a positive control. Dosing was followed by exercise challenges at 2, 8.5, and 24 h. The primary end point was maximum ΔFEV1 at 2 h postdose. Secondary end points included maximum ΔFEV1 at the two later time points, and other measures (including recovery time and need for β-agonist rescue) at all time points. Results: The maximum ΔFEV1 magnitudes at 2, 8.5, and 24 h were significantly smaller after montelukast administration than after placebo administration (least squares mean [± SE], 13.2 ± 1.2%, 11.7 ± 1.2%, and 10.0 ± 1.1% vs 21.8 ± 1.2%, 16.8 ± 1.3%, and 14.0 ± 1.1%, respectively; p ≤ 0.001, < 0.01, and < 0.05). All secondary end point results supported the primary end point. Montelukast and salmeterol had similar efficacy at 2 and 8.5 h, but only montelukast was effective at 24 h. Conclusion: Montelukast provided significant protection against EIB having an onset within 2 h following a single oral dose and lasting for at least 24 h.
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Citations

Philip, G., Pearlman, D. S., Villarán, C., Legrand, C., Loeys, T., Langdon, R. B., Reiss, T., & et al. (2007). Single-Dose Montelukast or Salmeterol as Protection Against Exercise-Induced Bronchoconstriction. Chest : the cardiopulmonary and critical care journal, 132(3), 875-883. https://doi.org/10.1378/chest.07-0550 (Original work published 2007)