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Short-Term Growth During Treatment with Inhaled Fluticasone Propionate/Formoterol, Fluticasone and Beclomethasone
Ole D Wolthers1, Ainslee Moore2, Sabine Mersmann3
11 Asthma and Allergy Clinic, Children's Clinic Randers , Randers, Denmark .
Insights
Fluticasone propionate/formoterol (FP/FORM) and fluticasone propionate (FP) inhalers did not impact growth in children with asthma. However, beclomethasone dipropionate (BDP) inhalers suppressed short-term growth.
Area of Science:
- Pediatric Pulmonology
- Asthma Therapeutics
- Growth Monitoring
Background:
- Fluticasone propionate/formoterol (FP/FORM) pMDI is approved for adolescents and adults, with pediatric development ongoing.
- Asthma management in children requires careful consideration of inhaled corticosteroid (ICS) side effects, including growth impacts.
Purpose of the Study:
- To compare the short-term effects on lower leg growth rate (LLGR) in children with asthma treated with FP/FORM pMDI, FP pMDI with a spacer, and extra-fine beclomethasone dipropionate (BDP) in a breath-actuated device.
Main Methods:
- A randomized, three-way crossover trial involving 48 children (5 to <12 years) with persistent asthma.
- Interventions included FP/FORM 100/10 μg b.i.d. with AeroChamber Plus spacer, FP 100 μg b.i.d. with Volumatic spacer, and extra-fine BDP 100 μg b.i.d. via Autohaler.
- Lower leg growth rate (LLGR) was assessed using knemometry over 2-week treatment periods.
Main Results:
- FP/FORM pMDI with AeroChamber and FP pMDI with Volumatic spacer showed no significant difference in LLGR compared to baseline or each other, demonstrating non-inferiority.
- Both FP/FORM and FP treatments did not alter the off-treatment growth rate.
- Extra-fine BDP delivered via a breath-actuated inhaler resulted in a statistically significant difference in LLGR compared to both FP/FORM and FP treatments.
Conclusions:
- FP/FORM pMDI used with an AeroChamber spacer and FP pMDI with a Volumatic spacer are safe regarding short-term lower leg growth in asthmatic children.
- Extra-fine BDP delivered via a breath-actuated inhaler was associated with short-term growth suppression in this pediatric asthma cohort.
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.
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