Abstract

Respimat®(RMT) is a reusable, propellant-free, soft mist inhaler (SMI), a novel device for inhalation therapy. We conducted a three-period cross-over study to evaluate the safety and efficacy of cumulative doses of ipratropium bromide inhaled from RMT (Two dose levels) or from a pressurized metered dose inhaler (MDI), in 36 patients with chronic obstructive pulmonary disease (COPD). The bronchodilator effect of ipratropium bromide was greater when administered via RMT (10 or 20 μ g per puff, given double-blind within device, to total doses of 160 or 320 μ g) than via MDI (20 μ g per puff, total dose 320 μ g). The bronchodilator effects of the 160 and 320 μ g doses delivered via RMT were similar. Cumulative ipratropium bromide doses of 320 μ g given via MDI or RMT and 160μ g given via RMT produced similar safety profiles. Between 45 min after the first drug inhalation and 45 min after the final dose, greater bronchodilatory effect was obtained from half the cumulative dose of ipratropium (RMT 10 μ g per puff) when compared with the MDI (20 μ g per puff). Therefore, ipratropium bromide delivered by RMT is as safe as, and can be more effective than, the MDI on acute administration in patients with COPD.

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