In Vivo Performance Testing of the Novel Medspray~R Wet Aerosol Inhaler

摘要

Background: Monodisperse salbutamol inhalers were compared to select the optimal mass median aerodynamic diameter: 4.0, 5.0 or 6.0 mum. Methods: Fifteen mild asthmatic patients participated. In all a FEV_1-response of >12% (vs. baseline) or >200mL after inhalation of 200 mug salbutamol was measured. Each patient was studied four times with intervals of 1 week (three active and one placebo inhaler). First, 10 mug salbutamol was administered, followed by 10, 20, and 40 mug, resulting in cumulative doses of 10, 20, 40, and 80 mug salbutamol. The FEV_1 and other lung function parameters were assessed at baseline and 30min after inhalation of each consecutive dose. Five minutes later a next inhalation was given. Results: The 4.0- and 5.0-mum droplets did not differ from placebo (p = 0.502, p = 0.127), but the 6.0-mum droplets differed significantly (p = 0.003). The difference between 6.0-4.0 mum droplets was significant (p-0.020), but not between the 6.0-5.0 mum droplets (p = 0.129). The FEV_1 increase after 80-mug salbutamol for the 6.0-mum droplets was 243+-144mL. Conclusions: The study showed that the 6.0-mum droplets differed from the others in terms of FEV_1-improvement, and hence, are the most efficacious of the three evaluated.