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 Ęg/day) and fluticasone propionate (100 Ęg/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 Ęg/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 Kidfs 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