Optimal step-down approach for pediatric asthma controlled by salmeterol/fluticasone: A randomized, controlled trial (OSCAR study)

Publication date: Available online 4 May 2016
Source:Allergology International
Author(s): Kenichi Akashi, Hidetoshi Mezawa, Yuichi Tabata, Jun Atsuta, Reiko Tokuda, Yasusuke Kawada, Tetsuro Kitamura, Hiroko Murasugi, Hiroaki Ito, Masahiko Tabata, Kenichiro Shirao, Satoshi Sato, Hideko Nishimura, Masako Fujiwara, Kei Masuda, Hirokazu Arakawa, Yuichi Adachi, Shigemi Yoshihara, Takao Fujisawa, Toshio Katsunuma
BackgroundSeveral guidelines, including the Japanese Pediatric Guideline for the Treatment and Management of Asthma (JPGL), recommend salmeterol/fluticasone combination therapy (SFC) as step 3 to 4 treatment for moderate to severe asthma. However, the optimal step-down approach to SFC remains unclear. In the current study, we examined step-down approaches in asthmatic children whose symptoms had been stabilized by SFC 100/200 μg/day.MethodsThis randomized, multicenter, open-label, parallel-group study was conducted over 12 weeks. For step-down therapy, subjects aged 5–15 years were randomly assigned to an SFC group (25/50 μg b.i.d.) or an FP group (100 μg b.i.d.), and treated for 12 weeks. Childhood Asthma Control Test (C-ACT) scores, lung function, and exhaled nitric oxide (FeNO) levels were monitored.ResultsOf 131 enrolled subjects, 128 completed the study and were included in the analysis. Decreases in % peak expiratory flow rate and % forced expiratory flow at 50% of vital capacity (V50) were observed in the FP group at each time point. There was a significant difference between the two groups for the change in %V50 from its previous value at each time point. There were no significant changes in FeNO levels (range 15–20 ppb) or C-ACT scores (∼26 points) within or between groups.ConclusionsA high level of asthma control was maintained with both approaches. The use of SFC step-down resulted in somewhat better respiratory function, with no worsening of airway inflammation. However, halving the dose of SFC and switching to FP alone are both optimal step-down approaches.



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