A randomized, placebo-controlled study to evaluate the role of salmeterol in the in-hospital management of asthma.
OBJECTIVE
To assess the safety and efficacy of salmeterol xinafoate as an adjunct to conventional therapy for the in-hospital management of acute asthma.


METHODS
A prospective, double-blind, randomized placebo-controlled trial.


METHODS
Medical wards of a large university-based hospital.


METHODS
Forty-three patients admitted for an acute exacerbation of asthma.


METHODS
Salmeterol (42 microg) or two puffs of placebo every 12 h in addition to standard therapy (short-acting beta-agonists, corticosteroids, and anticholinergic agents).


RESULTS
No clinically adverse effects were seen with the addition of salmeterol to conventional therapy. After salmeterol, there was no difference in pulse, respiratory rate, oxygen saturation by pulse oximetry, severity of symptoms, or dyspnea score. Patients receiving salmeterol had greater FEV(1) percent improvements than the placebo group at 12, 24, 36, and 48 h. These findings were not statistically significant. By paired Student's t tests, there were significant improvements in FEV(1) (p = 0.03) and FVC (p = 0.03) in the salmeterol group after 48 h of treatment with no comparable improvement in the placebo group. In a subgroup analysis of patients with an initial FEV(1) < or = 1.5 L, the absolute FEV(1) percent improvement for salmeterol vs placebo was 51% vs 16% at 24 h and 54% vs 40% at 48 h. The relative FEV(1) percent improvement for salmeterol vs placebo was 17% vs 8% at 24 h and 18% vs 14% at 48 h.


CONCLUSIONS
The addition of salmeterol to conventional therapy is safe and may benefit hospitalized patients with asthma. Further studies are needed to clarify its role in the treatment of acute exacerbation of asthma.
Peters
J I
JI
Department of Medicine, Division of Pulmonary Diseases/Critical Care Medicine, The University of Texas Health Science Center at San Antonio, USA. peters@uthscsa.edu
Shelledy
D C
DC
Jones
A P
AP
Lawson
R W
RW
Davis
C P
CP
LeGrand
T S
TS
D000208:Acute Disease; D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D000328:Adult; D000336:Aerosols; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D018680:Cholinergic Antagonists / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007297:Inpatients; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010092:Oximetry; D011446:Prospective Studies; D012129:Respiratory Function Tests; D012449:Safety; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome
D000318:Adrenergic beta-Agonists; D000336:Aerosols; D018680:Cholinergic Antagonists; D005938:Glucocorticoids; D000068299:Salmeterol Xinafoate; D000420:Albuterol