Virtual International Pediatric Pulmonary Network (VIPPN)

Editor’s Choice, February 2019

José Castro-Rodríguez MD

Yoshihara S, Tsubaki T, Ikeda M, Lenney W, Tomiak R, Hattori T, Hashimoto K, Soutome T, Kato S. The efficacy and safety of fluticasone/salmeterol compared to  fluticasone in children younger than four years of age. Pediatr Allergy Immunol. 2018 Dec 17. doi: 10.1111/pai.13010.

This is the first randomized, double-blind study designed to evaluate the use of combination therapy (ICS/LABA) in preschoolers with asthma. 

The authors randomized 300 asthmatic preschoolers (8 months to 4 years of age) comming from 70 pediatric centers in Japan. One group received fluticasone/salmeterol (50/25 ug) or fluticasone (50ug) 1 or 2 puff​ BID, according with age, for 8 weeks. They reported that preschoolers from the fluticasone/salmeterol group were not superior to those from the ICS group in improving total daily asthma score (main outcome), nor in secundary outcomes such as AM or PM asthma score, exacerbations, or rescue medication. The only secundary outcome were fluticasone/salmeterol was superior than ICS was in the Japanese Pediatric Asthma Control parameter, which is a local asthma score but without minimal clinically important difference (MCI) stablish, therefore this particular results is questionable. The adverse events were similar betwee groups.

No data on adherence was reported, and it was not clear if preschoolers less than 2 years of age received the therapeutic doses of salmeterol (50 ug BID).

In contrast to randomized studies done in schoolers or adolescents with moderate to severe asthma were ICS/LABA has advantage over ICS in asthma control and some lung function parameters, it appears that at this moment in asthmatic preschoolers there is no clear space for adding LABA. 

More randomized studies need to be done before we incorporate LABA in preschoolers with moderate-severe asthma.