Abstract
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. 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. 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. 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;...Continue Reading
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Dec 20, 2017·Clinical Drug Investigation·Ole D WolthersSanjeeva Dissanayake
Sep 19, 2019·BMJ Paediatrics Open·Ole D Wolthers
Jan 31, 2018·Therapeutic Advances in Respiratory Disease·Sanjeeva Dissanayake, Jason Suggett
May 21, 2021·Clinical Chemistry and Laboratory Medicine : CCLM·Ole D WolthersAnne Vibeke Schmedes