Study objectives: To assess the safety and efficacy of
salmeterol xinafoate as an adjunct to conventional therapy for the
in-hospital management of acute asthma.
prospective, double-blind, randomized placebo-controlled trial.
Setting: Medical wards of a large university-based
Patients: Forty-three patients admitted for
an acute exacerbation of asthma.
Salmeterol (42 μg) or two puffs of placebo every 12 h in
addition to standard therapy (short-acting β-agonists,
corticosteroids, and anticholinergic agents).
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 FEV1 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 FEV1 (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 FEV1 ≤ 1.5 L, the absolute
FEV1 percent improvement for salmeterol vs placebo was 51%
vs 16% at 24 h and 54% vs 40% at 48 h. The relative
FEV1 percent improvement for salmeterol vs placebo was 17%
vs 8% at 24 h and 18% vs 14% at 48 h.
Conclusion: 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.