Short-Term Growth During Treatment with Inhaled Fluticasone Propionate/Formoterol, Fluticasone and Beclomethasone Treatment. 2017

Ole D Wolthers, and Ainslee Moore, and Sabine Mersmann, and Sanjeeva Dissanayake
1 Asthma and Allergy Clinic, Children's Clinic Randers , Randers, Denmark .

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.

UI MeSH Term Description Entries
D007867 Leg Bones The bones of the free part of the lower extremity in humans and of any of the four extremities in animals. It includes the PATELLA; TIBIA; and FIBULA. Bones of Leg,Bone, Leg,Bones, Leg,Leg Bone
D008297 Male Males
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D004338 Drug Combinations Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture. Drug Combination,Combination, Drug,Combinations, Drug
D004983 Ethanolamines AMINO ALCOHOLS containing the ETHANOLAMINE; (-NH2CH2CHOH) group and its derivatives. Aminoethanols
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068298 Fluticasone A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS. Cutivate,Flixonase,Flixotide,Flonase,Flovent,Flovent HFA,Fluticasone Propionate,HFA, Flovent,Propionate, Fluticasone
D000068759 Formoterol Fumarate An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. 3-Formylamino-4-hydroxy-alpha-(N-1-methyl-2-p-methoxyphenethylaminomethyl)benzyl alcohol.hemifumarate,Arformoterol,BD 40A,Eformoterol,Foradil,Formoterol,Formoterol Fumarate, ((R*,R*)-(+-))-isomer,Formoterol, ((R*,R*)-(+-))-isomer,Oxis

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