Bronchodilating effects of salbutamol from a novel inhaler Airmax™

Abstract

This randomized, placebo-controlled, evaluator-blind, five-way crossover study compared the equivalence in terms of FEV1 response to single ascending cumulative doses of salbutamol (100-400 μg) from Airmax™, anew multidose dry powder inhaler, in comparison with placebo, the same dose from a standard pressurized metered dose inhaler (Ventolin®) or at double the dose from the dry powder inhalers Diskhaler® and Accuhaler®. Sixty-one adult asthmatic subjects with FEV1 50-80% predicted and ≥ 15% increase in FEV1 to salbutamol took part. Equivalence was declared if the 95% Cl for the ratio of the FEV1 responses to the two treatments was within the range 90-111%. Following the cumulative four doses, FEV1 (1) changes pre-dose to the highest dose were: 2.53-3.31, 2.47-3.30, 2,51-3.35, 2.52-3.31 and 2.57-2.55 for Airmax™ salbutamol, salbutamol Ventolin®, salbutamol Disklhaler® salbutamol Accuhaler® and placebo, respectively The 95% Cls for the ratio of Airmax™ salbutamol to each of the active devices were within ±5% demonstrating a 1:1 dose equivalence between Airmax™ salbutamol and Ventolin® and a 1:2 dose equivalence between each of the other two salbutamol dry powder devices. Adverse events profiles were similar for all treatments. In conclusion, the novel multidose inhaler Airmax™ salbutamol is as efficacious and safe as the pressurized metered dose inhaler without the need for co-ordinating actuation and inhalation and with the added benefit of a dose counter. © 2002 Published by Elsevier Science Ltd.