Journal of aerosol medicine and pulmonary drug delivery · 2017
Short-Term Growth During Treatment with Inhaled Fluticasone Propionate/Formoterol, Fluticasone and Beclomethasone Treatment.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Wolthers Ole D, Moore Ainslee, Mersmann Sabine, Dissanayake Sanjeeva
Аннотация
BACKGROUND: Fluticasone propionate/formoterol (FP/FORM) is a pressurized metered-dose inhaler (pMDI; Flutiform®) approved for use in adolescents and adults and under development for pediatric use.
OBJECTIVE: To compare short-term growth in asthmatic children treated with FP/FORM, FP pMDI with valved holding chamber, and beclomethasone dipropionate (BDP) in a breath-actuated device.
METHODS: Children with persistent asthma (n = 48; 5 to <12 years) participated in an assessor-blinded, randomized, three-way crossover trial with run in, wash out, and active treatment periods, each of 2 weeks duration. Interventions were FP/FORM 100/10 μg b.i.d. with an AeroChamber Plus® Flow-Vu® Spacer, FP pMDI (Flixotide®) 100 μg b.i.d. with a Volumatic® spacer, and extra-fine BDP breath-actuated inhaler (Aerobec®/QVAR® Autohaler®) 100 μg b.i.d. Lower leg growth rate (LLGR) was measured by knemometry.
RESULTS: The least square (LS) mean difference in LLGR between FP/FORM and FP (per protocol population) was -0.006 mm/week (95% CI: -0.095 to 0.084; p < 0.001 for noninferiority [noninferiority margin -0.200 mm/week]). Both treatments elicited no change from baseline off-treatment growth rate. The LS mean treatment difference of FP/FORM versus BDP was 0.116 mm/week (95% CI: -0.004 to 0.235; p = 0.057) and of FP versus BDP 0.163 mm/week (95% CI: 0.078-0.249; p < 0.001). Results in the full analysis population were: FP/FORM versus FP -0.012 mm/week (95% CI: -0.080-0.056; p < 0.001); FP/FORM versus BDP 0.143 mm/week (95% CI: 0.064-0.222; p < 0.001); FP versus BDP 0.163 mm/week (95% CI: 0.093-0.233; p < 0.001).
CONCLUSIONS: FP/FORM pMDI with AeroChamber and FP pMDI with Volumatic spacer did not affect lower leg growth, measured by knemometry, in asthmatic children. Conversely, extra-fine BDP from a breath-actuated inhaler resulted in short-term growth suppression.
OBJECTIVE: To compare short-term growth in asthmatic children treated with FP/FORM, FP pMDI with valved holding chamber, and beclomethasone dipropionate (BDP) in a breath-actuated device.
METHODS: Children with persistent asthma (n = 48; 5 to <12 years) participated in an assessor-blinded, randomized, three-way crossover trial with run in, wash out, and active treatment periods, each of 2 weeks duration. Interventions were FP/FORM 100/10 μg b.i.d. with an AeroChamber Plus® Flow-Vu® Spacer, FP pMDI (Flixotide®) 100 μg b.i.d. with a Volumatic® spacer, and extra-fine BDP breath-actuated inhaler (Aerobec®/QVAR® Autohaler®) 100 μg b.i.d. Lower leg growth rate (LLGR) was measured by knemometry.
RESULTS: The least square (LS) mean difference in LLGR between FP/FORM and FP (per protocol population) was -0.006 mm/week (95% CI: -0.095 to 0.084; p < 0.001 for noninferiority [noninferiority margin -0.200 mm/week]). Both treatments elicited no change from baseline off-treatment growth rate. The LS mean treatment difference of FP/FORM versus BDP was 0.116 mm/week (95% CI: -0.004 to 0.235; p = 0.057) and of FP versus BDP 0.163 mm/week (95% CI: 0.078-0.249; p < 0.001). Results in the full analysis population were: FP/FORM versus FP -0.012 mm/week (95% CI: -0.080-0.056; p < 0.001); FP/FORM versus BDP 0.143 mm/week (95% CI: 0.064-0.222; p < 0.001); FP versus BDP 0.163 mm/week (95% CI: 0.093-0.233; p < 0.001).
CONCLUSIONS: FP/FORM pMDI with AeroChamber and FP pMDI with Volumatic spacer did not affect lower leg growth, measured by knemometry, in asthmatic children. Conversely, extra-fine BDP from a breath-actuated inhaler resulted in short-term growth suppression.