6/29/23, 11:44 PM SMART Pathway Feedback Search Clinical Topics Home Studies SMART SMART Disease Asthma Trial question What is the effect of salmeterol plus usual pharmacotherapy in patients with asthma? Study design Multi-center Double blinded RCT Population Characteristics of study participants 63.6% female N = 26355 36.4% male 26355 patients (16671 female, 9389 male) Inclusion criteria: patients > 12 years of age with asthma Key exclusion criteria: pregnancy, high-risk significant systemic disease, history of adverse reaction to sympathomimetic amine drug, or current use of -blockers Interventions N=13176 salmeterol (42 g twice a day via metered-dose inhaler plus usual pharmacotherapy) N=13179 placebo (placebo metered-dose inhaler twice a day plus usual pharmacotherapy) Primary outcome Respiratory-related deaths or life-threatening experiences 0.4 % 0.38 https://web.pathway.md/studies/recUEYCHv4bQz51DH 1/2 6/29/23, 11:44 PM SMART Pathway 0 38 0.3 % 0.27 0.2 % 0.1 % No significant difference 0.0 % Salmeterol Placebo No significant difference in respiratory-related deaths or life-threatening experiences (0.38% vs. 0.27%; RR 1.4, 95% CI 0.91 to 2.14) Secondary outcomes Borderline significant increase in respiratory-related deaths (0.18% vs. 0.08%; RR 2.16, 95% CI 1.06 to 4.41) Borderline significant increase in asthma-related deaths (0.1% vs. 0.02%; RR 4.37, 95% CI 1.25 to 15.34) Borderline significant increase in asthma-related death or life-threatening experiences (0.28% vs. 0.17%; RR 1.71, 95% CI 1.01 to 2.89) Safety outcomes No significant difference in serious adverse events. Significant difference in survival rate in relation to time to the first serious adverse event causing discontinuation (95.61% vs. 96.18%). Conclusion In patients > 12 years of age with asthma, salmeterol was not superior to placebo with respect to a respiratory-related deaths or life-threatening experiences. Reference Nelson HS, Weiss ST, Bleecker ER et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006 Jan;129(1):15-26. Open reference URL https://web.pathway.md/studies/recUEYCHv4bQz51DH 2/2