start-ver=1.4 cd-journal=joma no-vol=66 cd-vols= no-issue=7 article-no= start-page=371 end-page=376 dt-received= dt-revised= dt-accepted= dt-pub-year=2016 dt-pub=201607 dt-online= en-article= kn-article= en-subject= kn-subject= en-title= kn-title=Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids en-subtitle= kn-subtitle= en-abstract= kn-abstract=Background: Clinical evidences of inhaled salmeterol/fluticasone propionate combination (SFC) therapy are insufficient in early childhood asthma.
Objectives: To examine the effects of SFC50, a combination product of salmeterol xinafoate (50 ƒĘg/day) and fluticasone propionate (100 ƒĘg/day), in infants and preschool children with asthma.
Methods: The study was conducted at 31 sites in Japan. 35 patients (6 months to 5 years old) with asthma insufficiently controlled by inhaled corticosteroids (100 ƒĘg/day) were initiated to treat with SFC50 twice a day for 12 weeks with pressurized metered dose inhalers. The efficacy of SFC50 was assessed using nighttime sleep disorder score as the primary endpoint and the other efficacy measurements. The safety measurement included the incidences of adverse event (AE).
Results: Mean patient age was 3.1 years, and 94.2% had mild-to-moderate persistent asthma (atopic type: 65.7%). Nighttime sleep disorder scores, assessed by a nighttime sleep diary, significantly decreased after treatment with SFC50 throughout the study period (p<0.01). SFC50 also significantly improved other efficacy outcomes including asthma symptom score, frequency of short-acting beta-agonist treatment, frequency of unscheduled visits to clinic, frequency of exacerbation due to virus infection, asthma control score and patient QOL score (p<0.01). AEs of cold, upper respiratory inflammation and asthmatic attack occurred in each of the 3 patients (8.6%); however, these were not regarded as treatment-related AEs.
Conclusions: SFC50 improved nighttime sleep disorder score and other efficacy outcome measures with no safety concerns. The results suggest that SFC50 treatment is useful to control the mild-to-moderate asthma in infant and preschool-aged children. en-copyright= kn-copyright= en-aut-name=YoshiharaS. en-aut-sei=Yoshihara en-aut-mei=S. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=1 ORCID= en-aut-name=FukudaH. en-aut-sei=Fukuda en-aut-mei=H. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=2 ORCID= en-aut-name=TamuraM. en-aut-sei=Tamura en-aut-mei=M. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=3 ORCID= en-aut-name=ArisakaO. en-aut-sei=Arisaka en-aut-mei=O. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=4 ORCID= en-aut-name=IkedaM. en-aut-sei=Ikeda en-aut-mei=M. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=5 ORCID= en-aut-name=FukudaN. en-aut-sei=Fukuda en-aut-mei=N. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=6 ORCID= en-aut-name=TsujiT. en-aut-sei=Tsuji en-aut-mei=T. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=7 ORCID= en-aut-name=HasegawaS. en-aut-sei=Hasegawa en-aut-mei=S. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=8 ORCID= en-aut-name=KannoN. en-aut-sei=Kanno en-aut-mei=N. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=9 ORCID= en-aut-name=TeraokaM. en-aut-sei=Teraoka en-aut-mei=M. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=10 ORCID= en-aut-name=WakiguchiH. en-aut-sei=Wakiguchi en-aut-mei=H. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=11 ORCID= en-aut-name=AokiY. en-aut-sei=Aoki en-aut-mei=Y. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=12 ORCID= en-aut-name=TeradaA. en-aut-sei=Terada en-aut-mei=A. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=13 ORCID= en-aut-name=HasegawaM. en-aut-sei=Hasegawa en-aut-mei=M. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=14 ORCID= en-aut-name=MankiA. en-aut-sei=Manki en-aut-mei=A. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=15 ORCID= en-aut-name=IgarashiH. en-aut-sei=Igarashi en-aut-mei=H. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=16 ORCID= affil-num=1 en-affil=Department of Pediatrics, Dokkyo Medical University kn-affil= affil-num=2 en-affil=Department of Pediatrics, Dokkyo Medical University kn-affil= affil-num=3 en-affil=Department of Pediatrics, Dokkyo Medical University kn-affil= affil-num=4 en-affil=Department of Pediatrics, Dokkyo Medical University kn-affil= affil-num=5 en-affil=Department of Pediatric Acute Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences kn-affil= affil-num=6 en-affil=Grimm Pediatrics and Allergy Clinic kn-affil= affil-num=7 en-affil=Department of Pediatrics, JA Hiroshima General Hospital kn-affil= affil-num=8 en-affil=Department of Pediatrics, Yamaguchi University Graduate School of Medicine kn-affil= affil-num=9 en-affil=Department of Pediatrics, Nishikata Hospital kn-affil= affil-num=10 en-affil=Department of Pediatrics, Kurashiki Municipal Hospital kn-affil= affil-num=11 en-affil=Department of Pediatrics, Yamaguchi University Graduate School of Medicine kn-affil= affil-num=12 en-affil=Department of Pediatrics, Nagato General Hospital kn-affil= affil-num=13 en-affil=Terada Kidfs Allergy & Asthma Clinic kn-affil= affil-num=14 en-affil=Department of Pediatrics, Yamaguchi Grand Medical Center kn-affil= affil-num=15 en-affil=Department of Pediatrics, Okayama City Hospital kn-affil= affil-num=16 en-affil=Department of Pediatrics, Nogi Hospital kn-affil= en-keyword=salmeterol/fluticasone combination kn-keyword=salmeterol/fluticasone combination en-keyword=asthma kn-keyword=asthma en-keyword=infant kn-keyword=infant en-keyword=preschool children kn-keyword=preschool children en-keyword=nighttime sleep disorder score kn-keyword=nighttime sleep disorder score en-keyword=long-acting beta-agonist kn-keyword=long-acting beta-agonist en-keyword= inhaled corticosteroid kn-keyword= inhaled corticosteroid END