In Vitro Performance Characteristics of Valved Holding Chamber and Spacer Devices with a Fluticasone Metered-Dose Inhaler

Abstract

Study Objective. To compare the in vitro aerosol deposition characteristics of several commercially available valved holding chamber (VHC) and spacer devices used with a fluticasone metered-dose inhaler (MDI). Design. In vitro aerosol deposition study. Setting. University-affiliated research center. Devices. Seven VHC devices: BreatheRite, E-Z Spacer, EasiVent, AeroChamber, InspirEase, OptiChamber, and Space Chamber. Six spacer devices: OptiHaler, Aerosol Cloud Enhancer (ACE), Gentle-Haler, MediSpacer, Ellipse, and a 6-inch tube (1-inch inside diameter). Intervention. The respirable dose (aerosol particles 1-5 μm) of fluticasone was determined by sampling 10 220-μg actuations from five runs with each spacer or VHC plus MDI combination, by using a well-established in vitro cascade impactor method. Measurements and Main Results. Fluticasone aerosol was washed from the impactor with methanol and quantified by means of high-performance liquid chromatography. Differences among outcomes were determined with analysis-of-variance testing. Among spacers, Ellipse had the highest respirable dose (104 μg, p<0.01). Respirable doses for the 6-inch tube (74.3 μg), Gentle-Haler (81.7 μg), and MediSpacer (82.6 μg) were no different from that of the MDI (p>0.05), whereas respirable doses of OptiHaler (44.6 μg) and ACE (47.2 μg) were less than those of all other spacers (p<0.001). Among VHC devices, respirable doses from EasiVent (35.6 μg), AeroChamber (47.0 μg), InspirEase (52.7 μg), OptiChamber (53.1 μg), and Space Chamber (58.3 μg) were not different (p>0.05), whereas BreatheRite (13.1 μg) and E-Z Spacer (27.3 μg) respirable doses were less than those of the other VHC devices (p<0.05). Conclusion. Spacers and VHC devices available in the United States do not demonstrate equivalent in vitro performance with the fluticasone MDI. The difference between highest and lowest respirable doses in each device category would likely lead to clinically relevant differences in the quantity of fluticasone delivered to a patient.