Randomised, placebo controlled trial of effect of a leukotriene receptor antagonist, montelukast, on tapering inhaled corticosteroids in asthmatic patients.
OBJECTIVE
To determine the ability of montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients.


METHODS
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.


METHODS
23 academic asthma centres in United States, Canada, and Europe.


METHODS
226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to montelukast and 113 to placebo).


METHODS
Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score.


METHODS
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.
University Hospital, Lund, Sweden.
C G
CG
Löfdahl
T F
TF
Reiss
J A
JA
Leff
E
E
Israel
M J
MJ
Noonan
A F
AF
Finn
B C
BC
Seidenberg
T
T
Capizzi
S
S
Kundu
P
P
Godard
D000085:Acetates / Q000627:therapeutic use*; D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002908:Chronic Disease; D003521:Cyclopropanes; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D020024:Leukotriene Antagonists; D008168:Lung / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000627:therapeutic use*; D016037:Single-Blind Method; D013440:Sulfides
D000085:Acetates; D003521:Cyclopropanes; D005938:Glucocorticoids; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast