David A Stempel, Stanley J Szefler, Søren Pedersen, Robert S Zeiger, Anne M Yeakey, Laurie A Lee, Andrew H Liu, Herman Mitchell, Kenneth M Kral, Ibrahim H Raphiou, Barbara A Prillaman, Kathleen S Buaron, Suyong Yun Kirby, Steven J Pascoe
BACKGROUND: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children. METHODS: We randomly assigned, in a 1:1 ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks...
September 1, 2016: New England Journal of Medicine