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Summary: The aim of these studies was to compare the efficacy and the safety of tiotropium, delivered via Respimat® Soft MistTM Inhaler (SMI), a novel multi-dose, propellant-free inhaler, with ipratropium pressurized metered-dose inhaler (pMDI) in chronic obstructive pulmonary disease (COPD) patients. Two identical, 12-week, multi-national, randomized, double-blind, double-dummy, parallel-group, active- and placebo-controlled studies were performed. COPD patients were randomized to treatment with either inhaled tiotropium (5 or 10μg) via Respimat® SMI administered once daily, ipratropium (36μg) pMDI QID or placebo. The primary endpoint was the mean trough forced expiratory volume in 1s (FEV1) response after 12 weeks of treatment. Secondary endpoints included other spirometry measures and rescue medication use. A total of 719 patients were randomized; the majority were male (69%) with a mean pre-bronchodilator FEV1 (% predicted) of 40.7%. The mean treatment differences between tiotropium 5 and 10μg and placebo for the primary endpoint (mean trough FEV1 response at week 12) were 0.118 and 0.149L, respectively (both P<0.0001). Treatment differences between tiotropium 5 and 10μg and ipratropium were 0.064L (P=0.006) and 0.095L (P<0.0001). The increases in peak FEV1, FEV1 AUC(0–6h) and FVC for both tiotropium doses were statistically superior to placebo (P<0.01) and higher than ipratropium. All active treatments significantly reduced the rescue medication use compared with placebo, but only tiotropium 10μg was statistically superior to ipratropium (P=0.04). The incidence of adverse events was comparable across groups. In conclusion, tiotropium 5 and 10μg daily, delivered via Respimat® SMI, significantly improved lung function compared with ipratropium pMDI and placebo. [Copyright &y& Elsevier]

Summary: Although the principles of asthma management are well established in Europe, the available data indicate that asthma in patients is not well controlled. Many patients derive incomplete benefit from their inhaled medication because they do not use inhaler devices correctly and this may compromise asthma control. The Aerosol Drug Management Improvement Team (ADMIT), incorporating clinicians from the UK, Germany, France, Italy, Spain and The Netherlands, reviewed published evidence to examine ways to improve the treatment of reversible airways disease in Europe. Data indicate that there is a clear need for specific training of patients in correct inhalation technique for the various devices currently available, and this should be repeated frequently to maintain correct inhalation technique. Devices which provide reassurance to patients and their physicians that inhalation is performed correctly should help to improve patient compliance and asthma control. Educational efforts should also focus on primary prescribers of inhaler devices. ADMIT recommends dissemination of information on the correct inhalation technique for each model of device by the use of an accessible dedicated literature base or website which would enable to match the appropriate inhaler to the individual patient. There is also a need for standardisation of prescribing practices throughout Europe. Regular checking of inhalation technique by prescribers is crucial as correct inhalation is one of the keystones of successful asthma management. [Copyright &y& Elsevier]

Respimat® Soft Mist™ Inhaler (SMI) is a new generation inhaler from Boehringer Ingelheim developed for use with respiratory drugs. The device functions by forcing a metered dose of drug solution through a unique and precisely engineered nozzle (the uniblock), producing two fine jets of liquid that converge at a pre-set angle. The collision of these two jets generates the soft mist. The soft mist contains a high fine particle fraction of approximately 65 to 80%. This is higher than aerosol clouds from conventional portable inhaler devices, such as pressurised metered dose inhalers (pMDIs) and dry powder inhalers (DPIs). In addition, the relatively long generation time of the aerosol cloud (approximately 1.5s) facilitates co-ordination of inhalation and actuation – a major problem with pMDIs. These features, together with the slow velocity of the soft mist, result in larger amounts of the drug reaching the lungs and less being deposited in the oropharynx compared with either pMDIs or DPIs. Generation of the soft mist from Respimat® SMI is purely mechanical, so propellants are not necessary. The innovative design of Respimat® SMI, using water-based drug formulations, ensures patients receive consistent and reliable doses of the drug with each actuation. The device was initially tested in scintigraphic lung deposition studies and produced encouraging results when compared with the chlorofluorocarbon-based pMDI (CFC-MDI). Subsequent clinical studies have confirmed that Respimat® SMI is effective and safe in delivering bronchodilators to patients with asthma or chronic obstructive pulmonary disease. [Copyright &y& Elsevier]