Abstract
Background: Fluticasone propionate 50 μg/salmeterol xinafoate 25 μg (FP/SAL) is widely used in adults and children with asthma, but there is sparse information on its use in very young children. Methods: This was a randomized, double-blind, multicentre, controlled trial conducted in children aged 8 months to 4 years. During a 2-week run-in period, they all received FP twice daily. At randomization, they commenced FP/SAL or FP twice daily for 8 weeks. All were then given FP/SAL only, in a 16-week open-label study continuation. Medications were inhaled through an AeroChamber Plus with attached face mask. The primary end-point was mean change in total asthma symptom scores from baseline to the last 7 days of the double-blind period. Analyses were undertaken in all children randomized to treatment and who received at least one dose of study medication. Results: Three hundred children were randomized 1:1 to receive FP/SAL or FP. Mean change from baseline in total asthma symptom scores was –3.97 for FP/SAL and –3.01 with FP. The between-group difference was not statistically significant (P = 0.21; 95% confidence interval: −2.47, 0.54). No new safety signals were seen with FP/SAL. Conclusion: This is the first randomized, double-blind study of this size to evaluate FP/SAL in very young children with asthma. FP/SAL did not show superior efficacy to FP; no clear add-on effect of SAL was demonstrated. No clinically significant differences in safety were noted with FP/SAL usage.
| Original language | English |
|---|---|
| Pages (from-to) | 195-203 |
| Number of pages | 9 |
| Journal | Pediatric Allergy and Immunology |
| Volume | 30 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Mar 1 2019 |
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Keywords
- asthma
- child
- combination therapy
- double-blind
- fluticasone propionate
- randomized
- salbutamol
- salmeterol
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Immunology and Allergy
- Immunology
Cite this
The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age. / Yoshihara, Shigemi; Tsubaki, Toshikazu; Ikeda, Masanori; Lenney, Warren; Tomiak, Richard; Hattori, Takako; Hashimoto, Kenichi; Soutome, Toru; Kato, Shihona.
In: Pediatric Allergy and Immunology, Vol. 30, No. 2, 01.03.2019, p. 195-203.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age
AU - Yoshihara, Shigemi
AU - Tsubaki, Toshikazu
AU - Ikeda, Masanori
AU - Lenney, Warren
AU - Tomiak, Richard
AU - Hattori, Takako
AU - Hashimoto, Kenichi
AU - Soutome, Toru
AU - Kato, Shihona
PY - 2019/3/1
Y1 - 2019/3/1
N2 - Background: Fluticasone propionate 50 μg/salmeterol xinafoate 25 μg (FP/SAL) is widely used in adults and children with asthma, but there is sparse information on its use in very young children. Methods: This was a randomized, double-blind, multicentre, controlled trial conducted in children aged 8 months to 4 years. During a 2-week run-in period, they all received FP twice daily. At randomization, they commenced FP/SAL or FP twice daily for 8 weeks. All were then given FP/SAL only, in a 16-week open-label study continuation. Medications were inhaled through an AeroChamber Plus with attached face mask. The primary end-point was mean change in total asthma symptom scores from baseline to the last 7 days of the double-blind period. Analyses were undertaken in all children randomized to treatment and who received at least one dose of study medication. Results: Three hundred children were randomized 1:1 to receive FP/SAL or FP. Mean change from baseline in total asthma symptom scores was –3.97 for FP/SAL and –3.01 with FP. The between-group difference was not statistically significant (P = 0.21; 95% confidence interval: −2.47, 0.54). No new safety signals were seen with FP/SAL. Conclusion: This is the first randomized, double-blind study of this size to evaluate FP/SAL in very young children with asthma. FP/SAL did not show superior efficacy to FP; no clear add-on effect of SAL was demonstrated. No clinically significant differences in safety were noted with FP/SAL usage.
AB - Background: Fluticasone propionate 50 μg/salmeterol xinafoate 25 μg (FP/SAL) is widely used in adults and children with asthma, but there is sparse information on its use in very young children. Methods: This was a randomized, double-blind, multicentre, controlled trial conducted in children aged 8 months to 4 years. During a 2-week run-in period, they all received FP twice daily. At randomization, they commenced FP/SAL or FP twice daily for 8 weeks. All were then given FP/SAL only, in a 16-week open-label study continuation. Medications were inhaled through an AeroChamber Plus with attached face mask. The primary end-point was mean change in total asthma symptom scores from baseline to the last 7 days of the double-blind period. Analyses were undertaken in all children randomized to treatment and who received at least one dose of study medication. Results: Three hundred children were randomized 1:1 to receive FP/SAL or FP. Mean change from baseline in total asthma symptom scores was –3.97 for FP/SAL and –3.01 with FP. The between-group difference was not statistically significant (P = 0.21; 95% confidence interval: −2.47, 0.54). No new safety signals were seen with FP/SAL. Conclusion: This is the first randomized, double-blind study of this size to evaluate FP/SAL in very young children with asthma. FP/SAL did not show superior efficacy to FP; no clear add-on effect of SAL was demonstrated. No clinically significant differences in safety were noted with FP/SAL usage.
KW - asthma
KW - child
KW - combination therapy
KW - double-blind
KW - fluticasone propionate
KW - randomized
KW - salbutamol
KW - salmeterol
UR - http://www.scopus.com/inward/record.url?scp=85061341826&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061341826&partnerID=8YFLogxK
U2 - 10.1111/pai.13010
DO - 10.1111/pai.13010
M3 - Article
VL - 30
SP - 195
EP - 203
JO - Pediatric Allergy and Immunology
JF - Pediatric Allergy and Immunology
SN - 0905-6157
IS - 2
ER -