A randomized, placebo-controlled trial (RCT) of salmeterol in the in-hospital management of acute asthma

Jay I. Peters, D. C. Shelledy, A. P. Jones, W. Lawson, C. P. Davis, T. S. LeGrand

Research output: Contribution to journalArticlepeer-review


Purpose: 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 double blind RCT design was used. Patients (N=43) hospitalized for acute asthma were randomly assigned to receive 2 puffs of salmeterol or placebo q12 hours beginning the first day of admission. Both groups also received conventional therapy based on NIH guidelines. Outcome measures included: PEFR, FEV1, FVC, pulse, respirations, SpO2, severity of symptoms, dyspnea score and FEV1 and FVC percent improvement. Between group differences were evaluated by independent t-test. A paired t-test was used within groups to identify significant improvements. Chi-square was used to compare the two groups on frequency of complications. Results: There were no significant differences between groups on pulse, respiratory rate, SpO2, severity of symptoms, dyspnea score or length of stay. Patients receiving salmeterol had greater FEV1 percent improvements than the placebo group at 12, 24, 36 and 48 hours. These findings were not statistically significant. By paired t-test, there were significant improvements in FEV1 (p = .03) and FVC (p = .03) in the salmeterol group following 48 hours of treatment with no comparable improvement in the placebo group. Although no patient clinically deteriorated, 6 patients experienced a decline in FEV1 > 20% following one administration of salmeterol compared to 3 patients in the placebo group. This difference was not significant (p = .30). Conclusions: Patients receiving salmeterol tended to have a greater FEV1 percent improvement. A larger sample would be needed to demonstrate statistical significance. The salmeterol group had a significant improvement in FEV1 and FVC at 48 hours. Clinical Implications: The addition of salmeterol to conventional therapy may benefit hospitalized patients, however, some patients may experience a decrease in FEV1 immediately following treatment.

Original languageEnglish (US)
Pages (from-to)295S
Issue number4 SUPPL.
StatePublished - Oct 1998

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine


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