Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma.
BACKGROUND
Salmeterol, a long-acting beta2 -agonist, and zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients.


OBJECTIVE
We sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral zafirlukast in the treatment of persistent asthma.


METHODS
This was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurrent inhaled corticosteroid regimen, were treated for 4 weeks with either inhaled salmeterol xinafoate 42 microgram twice daily administered by means of a metered-dose inhaler or oral zafirlukast 20 mg twice daily. The primary efficacy measure was morning peak expiratory flow (PEF); secondary efficacy measures included evening PEF, asthma symptom scores, supplemental albuterol use, nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV1.


RESULTS
Both inhaled salmeterol and oral zafirlukast resulted in within-group improvements from baseline in measures of pulmonary function, asthma symptoms, and supplemental albuterol use. Salmeterol treatment resulted in significantly greater improvements from baseline compared with zafirlukast for most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P </= .001), percentage of symptom-free days (22.4% vs 8.8%; P </= .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P </= .001). There were no differences in safety profiles as assessed by adverse event monitoring.


CONCLUSIONS
In patients with persistent asthma, most of whom were concurrently using inhaled corticosteroids, treatment with inhaled salmeterol provided significantly greater improvement than oral zafirlukast in overall asthma control over the 4-week treatment period.
Busse
W
W
University of Wisconsin-Madison Medical School, Madison, WI, USA.
Nelson
H
H
Wolfe
J
J
Kalberg
C
C
Yancey
S W
SW
Rickard
K A
KA
D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000494:pharmacology; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002940:Circadian Rhythm; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D008168:Lung / Q000502:physiology; D008297:Male; D008875:Middle Aged; D048448:Phenylcarbamates; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate; D012720:Severity of Illness Index; D013449:Sulfonamides; D013810:Therapeutic Equivalency; D014105:Tosyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D007211:Indoles; D020024:Leukotriene Antagonists; D048448:Phenylcarbamates; D013449:Sulfonamides; D014105:Tosyl Compounds; D000068299:Salmeterol Xinafoate; D000420:Albuterol; C062735:zafirlukast