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Clinical Trial
. 1999 Jul 10;319(7202):87-90.
doi: 10.1136/bmj.319.7202.87.

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

C G Löfdahl  1 , T F Reiss, J A Leff, E Israel, M J Noonan, A F Finn, B C Seidenberg, T Capizzi, S Kundu, P Godard
Affiliations
Clinical Trial

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

C G Löfdahl et al. BMJ. .

Abstract

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.

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References

    1. US Department of Health and Human Services. National Heart, Lung, and Blood Institute/World Health Organisation Workshop Report. Global initiative for asthma: global strategy for asthma management and prevention. Bethesda, MD: National Heart, Lung, and Blood Institute, National Institutes of Health; 1995. (Publication No 95-3659, chapter 7.)
    1. Pauwels RA, Lofdahl CG, Postma DS, Tattersfield AE, O’Byrne P, Barnes PJ, et al. for the Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. Effect of inhaled formoterol and budesonide on exacerbations of asthma N Engl J Med 19973371405–1411. - PubMed
    1. Greening AP, Ind PW, Northfield M, Shaw G.on behalf of Allen and Hanburys Limited UK Study Group. Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid Lancet 1994344219–224. - PubMed
    1. Dworski RT, Fitzgerald GA, Oates JA, Sheller JR. Effect of oral prednisone on airway inflammatory mediators in atopic asthma. Am J Respir Crit Care Med. 1994;149:953–959. - PubMed
    1. Rididick CA, Ring WL, Baker JR, Hodulik CR, Bigby TD. Dexamethasone increases expression of 5-lipoxygenase and its activating protein in human monocytes and THP-1 cells. Eur J Biochem. 1997;246:112–118. - PubMed

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