Montelukast as add-on therapy to inhaled corticosteroids in the management of asthma (the SAS trial).
OBJECTIVE
To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy.


METHODS
An eight-week, multicentre, open-label, observational study.


RESULTS
Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean +/- SD ACQ score decreased from 1.13+/-0.28 to 0.57+/-0.50 (P<0.001) for controlled patients at baseline and from 2.38+/-0.73 to 1.03+/-0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement.


CONCLUSIONS
Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.
FitzGerald
J Mark
JM
Respiratory Division, University of British Columbia, Vancouver, Canada.
Foucart
Sylvain
S
Coyle
Stephen
S
Sampalis
John
J
Haine
Denis
D
Psaradellis
Eliofotisti
E
McIvor
R Andrew
RA
D000085:Acetates / Q000008:administration & dosage*; D000280:Administration, Inhalation; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage*; D013440:Sulfides; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D005938:Glucocorticoids; D011804:Quinolines; D013440:Sulfides; C093875:montelukast