BMJ 1999;319:87-90 ( 10 July )

Papers

Randomised, placebo controlled trial of effect of a leukotriene receptor antagonist, montelukast, on tapering inhaled corticosteroids in asthmatic patients

Claes-Göran Löfdahl, professor of respiratory medicine, a Theodore F Reiss, senior director, b Jonathan A Leff, associate director, b Elliot Israel, director, clinical research, d Michael J Noonan, clinical investigator, e Albert F Finn, clinical associate professor of medicine, microbiology, and immunology, f Beth C Seidenberg, vice president, clinical research, b Thomas Capizzi, senior director, clinical biostatistics, c Sudeep Kundu, senior biometrician, c Philippe Godard, professor of medicine. g

a University Hospital, Lund, Sweden, b Department of Pulmonary and Immunology, Merck Research Laboratories, Rahway, NJ 07065, USA, c Department of Biostatistic and Research Data System, Merck Research Laboratories, d Brigham and Women's Hospital, Boston, MA, USA, e Allergy Associate PC Research Center, Portland, OR, USA, f Allergy and Asthma Centers of Charleston, North Charleston, SC, USA, g Arnaud de Vilenueve Hospital, Montpellier, France

Correspondence to: T F Reiss Theodore_Reiss{at}Merck.com

Objective: To determine the ability of montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients.
Design: Double blind, randomised, placebo controlled, parallel group study. After a single blind placebo run in period, during which (at most) two inhaled corticosteroids dose decreases occurred, qualifying, clinically stable patients were allocated randomly to receive montelukast (10 mg tablet) or matching placebo once daily at bedtime for up to 12 weeks.
Setting: 23 academic asthma centres in United States, Canada, and Europe.
Participants: 226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to montelukast and 113 to placebo).
Interventions: Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score.
Main outcome measures: Last tolerated dose of inhaled corticosteroids.
Results: Compared with placebo, montelukast allowed significant (P=0.046) reduction in the inhaled corticosteroid dose (montelukast 47% v placebo 30%; least square mean difference 17.6%, 95% confidence interval 0.3 to 34.8). Fewer patients on montelukast (18 (16%) v 34 (30%) placebo, P=0.01) required discontinuation because of failed rescue.
Conclusions: Montelukast reduces the need for inhaled corticosteroids among patients requiring moderate to high doses of corticosteroid to maintain asthma control.


Key messages

  • Leukotriene receptor antagonists have complementary action to inhaled corticosteroids in asthma

  • Many patients receive higher doses of inhaled corticosteroids than clinically required

  • In this placebo controlled trial, montelukast allowed significant reduction of inhaled corticosteroid doses

  • Fewer patients receiving montelukast had failed rescue than patients receiving placebo




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Relevant Article

Leukotriene receptor antagonist reduces need for inhaled corticosteroids
BMJ 1999 319: 0. [Full Text]

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Rapid Responses:

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conclusion?
Yogi Sehgal
bmj.com, 11 Jul 1999 [Full text]
Recommending reduced dosages ignores real life conditions
Israel Amirav
bmj.com, 13 Aug 1999 [Full text]
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