[Critical evaluation of inhalation spacer devices available in France].

OBJECTIVE: To identify the spacer devices sold in France and to provide a critical evaluation in the light of the published data.

MATERIALS AND METHODS: We contacted the pharmaceutical companies, manufacturers and distributors of each spacer in order to obtain their technical parameters and the results of any in vitro or in vivo studies. A review of the literature via PubMed completed the first set of data. We were interested in the quantity of fine particles (less than 5 μm diameter) obtained with a cascade impactor at paediatric flow rates, for all inhaled drugs available in France.

RESULTS: Eleven spacer devices were available in 2013 in France (Ablespacer®, Aerochamber Plus®, Babyhaler®, VHC Arrow®, L'Espace®, Funhaler®, Inhaler®, Itinhaler®, OptiChamber Diamond®, Tipshaler® and Vortex®), but three are no longer manufactured (Babyhaler®, Funhaler® and Inhaler®). All were small volume spacers, sold with facial masks of several different sizes. Four were antistatic (Aerochamber Plus®, Intinhaler®, OptiChamber Diamond® and Vortex®). Only salbutamol was tested with all the devices. Inhaled corticosteroids were tested with some and combinations were studied only with Ablespacer®, Aerochamber Plus®, Itinhaler®, and Vortex®. The results were difficult to interpret because the studies were conducted with very different protocols. The only clinical studies were conducted with Aerochamber Plus®, L'Espace® and Vortex®.

CONCLUSION: There was a great disparity between commercialized spacer devices in terms of the available data describing their in vitro performance.