Tiotropium Respimat at a dose of 5 μg or 2.5 μg had a safety profile and exacerbation efficacy similar to those of tiotropium HandiHaler at a dose of 18 μg in patients with COPD. (Funded by Boehringer Ingelheim; TIOSPIR ClinicalTrials.gov number, NCT01126437.).

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The Respimat Ò Soft Mist TM Inhaler represents a unique delivery system for respiratory medications, using an innovative concept with major technological advancements made during prototype development. The Respimat Ò concept was driven by the intent to solve problems associated with existing inhaler devices for patient use. The following core aims were achieved: (1) avoiding propellants while reducing requirements for patient coordination and inspiratory effort; (2) optimizing drug delivery to the lungs, and; (3) improving the patients' experience of taking their inhaled medication. The RespimatÒ inhaler is the first-marketed, pocket-sized inhaler to successfully generate a metered dose of therapeutic aerosol mist from an aqueous solution. Patient feedback has strongly influenced the evolution of the Respimat Ò inhaler design and instructions for use. The availability of Respimat Ò augments options for clinicians and patients seeking to choose an inhaler that can effectively and consistently deliver respiratory medication to targeted areas of the lung. In many countries worldwide, Respimat Ò is available for the administration of tiotropium, olodaterol (and tiotropium/olodaterol in fixed-dose combination), ipratropium/fenoterol, and ipratropium/albuterol. Funding: Boehringer Ingelheim.

Background: Respimat® Soft Mist™ Inhaler (SMI) is a hand-held device that generates an aerosol with a high, fine-particle fraction, enabling efficient lung deposition. The study objective was to assess inhalation success among children using Respimat SMI, and the requirement for assistance by the parent/caregiver and/or a valved holding chamber (VHC).Methods: This open-label study enrolled patients aged <5 years with respiratory disease and history of coughing and/or recurrent wheezing. Patients inhaled from the Respimat SMI (air only; no aerosol) using a stepwise configuration: “1” (dose released by child); “2” (dose released by parent/caregiver), and “3” (Respimat SMI with VHC, facemask, and parent/caregiver help). Co-primary endpoints included the ability to perform successful inhalation as assessed by the investigators using a standardized handling questionnaire and evaluation of the reasons for success. Inhalation profile in the successful handling configuration was verified with a pneumotachograph. Patient satisfaction and preferences were investigated in a questionnaire.Results: Of the children aged 4 to <5 years (n=27) and 3 to <4 years (n=30), 55.6% and 30.0%, respectively, achieved success without a VHC or help; with assistance, another 29.6% and 10.0%, respectively, achieved success, and the remaining children were successful with VHC. All children aged 2 to <3 years (n=20) achieved success with the Respimat SMI and VHC. Of those aged <2 years (n=22), 95.5% had successful handling of the Respimat SMI with VHC and parent/caregiver help. Inhalation flow profiles generally confirmed the outcome of the handling assessment by the investigators. Most parent/caregiver and/or child respondents were satisfied with operation, instructions for use, handling, and ease of holding the Respimat SMI with or without a VHC.Conclusions: The Respimat SMI is suitable for children aged <5 years; however, children aged <5 years are advised to add a VHC to complement its use.

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