Effects of montelukast and beclomethasone on airway function and asthma control.
BACKGROUND
Maintaining asthma control is a major objective of therapy. Traditionally, the effectiveness of asthma therapy has been judged primarily by its effect on airway function rather than on multiaspect asthma control.


OBJECTIVE
An inhaled corticosteroid and a leukotriene receptor antagonist were compared to determine whether they provided equivalent effects, as judged by days of asthma control.


METHODS
In a randomized, multicenter, double-blind, placebo-controlled, parallel-group study, asthmatic patients (n = 782) with FEV(1) percent predicted values of between 50% and 85% and a weekly average beta-agonist use of more than 2 puffs per day were randomized to receive montelukast (10 mg daily), beclomethasone (200 microg twice daily), or placebo treatment for 6 weeks in a double-dummy fashion. We examined the distribution of the primary end point: percentage of days of asthma control. Secondary end points included FEV(1), albuterol use, occurrence of an asthma attack, asthma flare-up, rescue corticosteroid use, sustained asthma control, and adverse experiences.


RESULTS
The percentage of days of asthma control was almost identical between the montelukast and beclomethasone groups (98% overlap in the distribution). Montelukast was at least equal to beclomethasone, and both were greater than placebo on the basis of frequency of asthma attacks, asthma flare-ups, and rescue corticosteroid use. Beclomethasone had a greater effect than montelukast and both treatments were better than placebo at improving FEV(1).


CONCLUSIONS
Montelukast was as effective as beclomethasone, as judged by indices of clinical control other than FEV(1). When evaluating the outcome of montelukast therapy, FEV(1) might underestimate clinical effectiveness.
Israel
Elliot
E
Brigham and Women's Hospital, Boston, MA 02115, USA.
Chervinsky
Paul S
PS
Friedman
Bruce
B
Van Bavel
Julius
J
Skalky
Carol S
CS
Ghannam
Asma F
AF
Bird
Steven R
SR
Edelman
Jonathan M
JM
D000085:Acetates / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000009:adverse effects / Q000627:therapeutic use*; D003521:Cyclopropanes; D004311:Double-Blind Method; D005541:Forced Expiratory Volume; D006801:Humans; D008875:Middle Aged; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D013440:Sulfides
D000085:Acetates; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D001507:Beclomethasone; C093875:montelukast