Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids

S. Yoshihara, H. Fukuda, M. Tamura, O. Arisaka, Masanori Ikeda, N. Fukuda, T. Tsuji, S. Hasegawa, N. Kanno, M. Teraoka, H. Wakiguchi, Y. Aoki, H. Igarashi, A. Terada, M. Hasegawa, A. Manki

Research output: Contribution to journalArticle

3 Citations (Scopus)

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 μg/day) and fluticasone propionate (100 μg/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 μg/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.

Original languageEnglish
Pages (from-to)371-376
Number of pages6
JournalDrug Research
Volume66
Issue number7
DOIs
Publication statusPublished - Jul 1 2016

Fingerprint

Preschool Children
Adrenal Cortex Hormones
Asthma
Safety
Therapeutics
Metered Dose Inhalers
Virus Diseases
Ambulatory Care
Infection Control
Salmeterol Xinafoate Drug Combination Fluticasone Propionate
Japan
Sleep
Outcome Assessment (Health Care)
Inflammation
Incidence
Sleep Wake Disorders

Keywords

  • asthma
  • infant
  • inhaled corticosteroid
  • long-acting beta-agonist
  • nighttime sleep disorder score
  • preschool children
  • salmeterol/fluticasone combination

ASJC Scopus subject areas

  • Drug Discovery
  • Medicine(all)

Cite this

Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids. / Yoshihara, S.; Fukuda, H.; Tamura, M.; Arisaka, O.; Ikeda, Masanori; Fukuda, N.; Tsuji, T.; Hasegawa, S.; Kanno, N.; Teraoka, M.; Wakiguchi, H.; Aoki, Y.; Igarashi, H.; Terada, A.; Hasegawa, M.; Manki, A.

In: Drug Research, Vol. 66, No. 7, 01.07.2016, p. 371-376.

Research output: Contribution to journalArticle

Yoshihara, S, Fukuda, H, Tamura, M, Arisaka, O, Ikeda, M, Fukuda, N, Tsuji, T, Hasegawa, S, Kanno, N, Teraoka, M, Wakiguchi, H, Aoki, Y, Igarashi, H, Terada, A, Hasegawa, M & Manki, A 2016, 'Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids', Drug Research, vol. 66, no. 7, pp. 371-376. https://doi.org/10.1055/s-0042-108852
Yoshihara, S. ; Fukuda, H. ; Tamura, M. ; Arisaka, O. ; Ikeda, Masanori ; Fukuda, N. ; Tsuji, T. ; Hasegawa, S. ; Kanno, N. ; Teraoka, M. ; Wakiguchi, H. ; Aoki, Y. ; Igarashi, H. ; Terada, A. ; Hasegawa, M. ; Manki, A. / Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids. In: Drug Research. 2016 ; Vol. 66, No. 7. pp. 371-376.
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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 μg/day) and fluticasone propionate (100 μg/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 μg/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.",
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AU - Fukuda, H.

AU - Tamura, M.

AU - Arisaka, O.

AU - Ikeda, Masanori

AU - Fukuda, N.

AU - Tsuji, T.

AU - Hasegawa, S.

AU - Kanno, N.

AU - Teraoka, M.

AU - Wakiguchi, H.

AU - Aoki, Y.

AU - Igarashi, H.

AU - Terada, A.

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N2 - 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 μg/day) and fluticasone propionate (100 μg/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 μg/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.

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