Systemic activity of inhaled beclomethasone dipropionate: a double-blind comparison of volume spacers
Article first published online: 29 AUG 2011
© 2011 The Author(s)/Acta Pædiatrica © 2011 Foundation Acta Pædiatrica
Volume 101, Issue 2, pages 159–163, February 2012
How to Cite
Wolthers, O. D. and Sergio, F. (2012), Systemic activity of inhaled beclomethasone dipropionate: a double-blind comparison of volume spacers. Acta Paediatrica, 101: 159–163. doi: 10.1111/j.1651-2227.2011.02430.x
- Issue published online: 9 JAN 2012
- Article first published online: 29 AUG 2011
- Accepted manuscript online: 25 JUL 2011 06:26AM EST
- Received 29 April 2011; revised 11 July 2011; accepted 21 July 2011.
- Beclomethasone dipropionate;
- Inhaled steroids;
- Short-term growth;
- Systemic activity;
- Volume spacers
Background: To which extent volume spacers may influence systemic activity of inhaled beclomethasone dipropionate (BDP) has not been evaluated.
Aim: To assess whether the AeroChamber Plus™ spacer is equivalent to the Volumatic™ spacer for administration of inhaled hydroflouroalkane 134a propelled BDP in terms of lower leg growth rate (LLGR).
Patients and methods: Prepubertal children with mild asthma (n = 26, aged 6–14 years) were included in a 3-time periods of 2 weeks duration randomized double-blind cross-over study with a single-blind placebo run-in and two washout periods. LLGR was measured with the knemometer. Interventions were inhaled BDP hydroflouroalkane 134a pressurized metered dose inhaler 100 μg and 200 μg b.i.d. with the AeroChamber Plus and 200 μg b.i.d. with the Volumatic spacer.
Results: Beclomethasone dipropionate 200 μg b.i.d. from the AeroChamber Plus was non-inferior to BDP 200 b.i.d. from the Volumatic spacer as the lower margin of confidence interval of the difference between treatments (−0.18 to 0.13 mm/week) was greater than the prespecified lower limit for non-inferiority (−0.20 mm/week). UFC/creatinine data showed no statistically significant variations.
Conclusion: The systemic activity of BDP, via the Volumatic™, and AeroChamber Plus™ spacers is similar. The AeroChamber Plus spacer may be used in children without risk of increasing systemic activity of BDP.