Systemic activity of inhaled beclomethasone dipropionate: a double-blind comparison of 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.

RCT Entities:   Population Interventions Outcomes