Clinical efficacy and safety of the combination of ipratropium bromide and fenoterol inhaled via the Respimat© Soft Mist ™ inhaler for relief of airflow obstruction

Abstract

Bronchodilators are key drugs in symptomatic as well as maintenance treatment of obstructive lung diseases such as chronic obstructive pulmonary disease and asthma. The short-acting anticholinergic ipratropium bromide and the short-acting beta(2)-adrenergic receptor agonist fenoterol hydrobromide have been available for combined use both as a pressurized metered-dose inhaler and as a solution for nebulization. Their combination at half the dose in the novel device, the Respimat Soft Mist inhaler (RMT), has been shown to provide therapeutic equivalence to their combination into a conventional pressurized metered-dose inhaler, both in terms of efficacy and safety in patients with chronic obstructive pulmonary disease or asthma, both adults and children. Dose reduction with the RMT has been made possible due to the physical characteristics of the aerosol cloud emitted from the RMT, facilitating correct inhalation and ensuring higher pulmonary deposition of the aerosolized bronchodilators. Post-marketing studies using validated questionnaires confirm a high level of satisfaction with the performance and convenience of the RMT device, a large majority of patients preferring the RMT to other inhaler systems.

The efficacy of tiotropium administered via Respimat® Soft Mist™ Inhaler or HandiHaler® in COPD patients

“…Previous studies have also shown that Respimat SMI allows relative dose reduction compared with other devices such as ipratropium/fenoterol pMDI. 5 Tiotropium administered from the multidose Respimat inhaler generates an aqueous aerosol with a delivered dose that is independent of the…”

“…2e4 Previously reported studies have shown that the delivery of ipratropium bromide/fenoterol hydrobromide via Respimat SMI is as safe and effective as delivery from an established metered-dose inhaler (MDI). 5,6 However, Respimat SMI has primarily been developed as an alternative delivery device for use with tiotropium, an established anticholinergic that provides prolonged M 3 receptor blockade. The lung function improvements associated with tiotropium HandiHaler â (the usual delivery vehicle) have been well established in clinical trials of COPD patients.…”

Higher lung deposition with Respimat^® Soft Mist™ Inhaler than HFA-MDI in COPD patients with poor technique

“…This is in keeping with clinical trials seen in patients with asthma and COPD who were treated at home (without supervision) with Berodual ® administered from either the Respimat ® SMI or from a pMDI. These studies showed that reducing the dose in the Respimat ® SMI to half, or even one quarter, of the nominal dose of the pMDI resulted in comparable effi cacy and safety (Kassner et al 2004;Vincken 2008). Teaching patients to inhale slowly and deeply and hold their breath for as long as they can increases further lung deposition from Respimat ® SMI.…”

A role of combined therapy with M-cholinolytic and β2-adrenomimetic drugs for bronchial obstruction

“…На практике это сочетание было реализовано в 2 фиксированных комбинациях бронхолитиков ко роткого действия -ипратропий / фенотерол и ипра тропий / сальбутамол, из которых 1 й получил в Рос сии наиболее широкое распространение и был включен в протоколы и стандарты ведения больных ХОБЛ и БА. Препарат появился в России в послед ней четверти XX века как содержащий фреон дози рованный аэрозольный ингалятор (ДАИ) Беродуал ® , форма была доработана и ДАИ стал более высоко дисперсным, перестал содержать фреон (Бероду ал Н ® ), был создан раствор для небулизации, а за тем -Беродуал с устройством Респимат, дающим медленное ультрамелкое дозированное облако аэро золя (Беродуал ® Респимат ® не зарегистрирован в Рос сии) [7].…”