Salmeterol Plus Fluticasone Does Not Increase Asthma Morbidity

Researchers from multiple institutions conducted a randomized controlled trial to evaluate the safety of the long-acting beta-agonist (LABA) salmeterol, added to fluticasone propionate in a fixed-dose combination in children with asthma. The study was conducted at 567 trial sites in 32 countries. Children, 4–11 years old, with consistent use of asthma medication during the prior 4 weeks, were eligible for enrollment. Study participants were randomized to receive 1 of 4 study treatments: (1) a fixed-dose combination of fluticasone propionate 100 μg plus salmeterol 50 μg, (2) fixed-dose fluticasone 250 μg plus salmeterol 50 μg, (3) fluticasone alone 100 μg, or (4) fluticasone alone 250 μg, all given twice daily for 26 weeks. The primary safety outcome was a first serious asthma-related event (including death, …