Are you engaged in making presentations for international symposia, congresses or educating your patients? Facilitate your work by using our high quality slides, covering the development of Respimat® Soft Mist™ Inhaler, its design and how it works, and the benefits that it has over current inhalers such as MDIs. Just browse the slides listed in the following sections:
Performance data
Video clip animation comparing Respimat® SMI with a pMDI
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Aerosol cloud duration: Respimat® SMI vs pMDIs
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This study used a video camera to compare the spray durations of aerosol clouds delivered via Respimat® SMI with those from a variety of CFC- and HFA-MDIs. The formulations in all of the CFC-MDIs and for salmeterol + fluticasone via HFA-MDI were suspensions. The formulations in all of the other HFA-MDIs and in Respimat® SMI were solutions.
Aerosol clouds generated via Respimat® SMI last considerably longer than those delivered by either CFC- or HFA-MDIs.
The Soft Mist™ characteristic of the aerosol cloud generated by Respimat® SMI results in improved lung and reduced oropharyngeal deposition compared with other devices.
Hochrainer D, Hölz H, Kreher C, et al. Comparison of the aerosol velocity and spray duration of Respimat® Soft Mist™ Inhaler and pressurised metered dose inhalers. J Aerosol Med 2005; accepted for publication.
Clinical studies
Improved delivery of IB/FEN via Respimat® SMI compared with CFC-MDI in asthma patients (dose-ranging study) (Slide 1)
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In a double-blind (within-device), single-dose crossover study, 62 patients with stable asthma were randomised at five study centres to receive five out of eight possible treatments: ipratropium bromide/fenoterol (IB/FEN) dosages of 5/12.5, 10/25, 20/50, 40/100 or 80/200 µg delivered via Respimat® SMI; IB/FEN dosages of 20/50 or 40/100 µg delivered using a conventional CFC-MDI; and placebo via Respimat® SMI.
Pulmonary function results were based on the per-protocol data set, comprising 47 patients. All IB/FEN treatments produced significantly greater increases in forced expiratory volume in 1 second (FEV1) than placebo (p=0.0001).
This slide shows the adjusted mean change in FEV
1 over the 6-hour period after dosing produced by each of the drug treatments. IB/FEN delivered via Respimat® SMI is as effective as higher doses given via a CFC-MDI.
Goldberg J, Freund E, Beckers B, et al. Improved delivery of fenoterol plus ipratropium bromide using Respimat® compared with a conventional metered dose inhaler. Eur Respir J 2001;
17: 225-32.
Improved delivery of IB/FEN via Respimat® SMI compared with CFC-MDI in asthma patients (dose-ranging study) (Slide 2)
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A log-linear dose-response relationship was observed for the average increase in FEV
1 from baseline over the 6-hour period after dosing, expressed as the area under the curve (AUC
0-6h).
A similar relationship was not observed for the two doses of IB/FEN administered via CFC-MDI.
The mean AUC
0-6h for four out of five Respimat® SMI dosages was superior to that obtained with the 40/100 µg dosage from the CFC-MDI.
Goldberg J, Freund E, Beckers B, et al. Improved delivery of fenoterol plus ipratropium bromide using Respimat® compared with a conventional metered dose inhaler. Eur Respir J 2001;
17: 225-32.
Patient preference
Respimat® SMI: Patient device satisfaction and preference questionnaire
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Many of the technological advances incorporated into Respimat® SMI were designed to make the device easier to use and handle than other currently available inhalers.Some indication of whether the features of Respimat® SMI make a genuine difference in everyday practice has been provided by analysis of questionnaires designed to measure patient satisfaction with the device.
Questionnaires were administered as post hoc market research to subsets of patients in two Respimat® SMI trials, one in Germany using IB/FEN and one completed in Canada using IB. In the German trial, 47 COPD patients completed questionnaires after receiving 12 weeks’ treatment with IB/FEN via Respimat® SMI. In the Canadian trial, 129 COPD patients completed questionnaires after receiving IB via Respimat® SMI for 6 months.
Barczok M, Perleberg C, Kardos P, Hodder R. Presented at VIII Deutsches Aerosol Therapie Seminar, Marburg, Germany. November 2003.
Patient device satisfaction and preference questionnaire: German study results
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In the German trial, 47 patients with COPD completed the patient device satisfaction and preference questionnaire after using Respimat® SMI for 12 weeks.
The patients were asked: "How long did it take you to feel confident in handling Respimat® SMI?"
The majority of patients (76.6%) felt confident in handling Respimat® SMI after using the device for only one day.
Barczok M, Perleberg C, Kardos P, Hodder R. Presented at VIII Deutsches Aerosol Therapie Seminar, Marburg, Germany. November 2003.
Patient education
The symptoms of asthma and COPD
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The history of asthma and COPD
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Background
Devices for inhalation therapy: Pressurised metered-dose inhalers (pMDIs)
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Pressurised metered-dose inhalers (pMDIs) dispense drugs by means of a pressurised propellant. They are compact, portable, easy to use, inexpensive, and have a high market appeal.
The phased withdrawal of chlorofluorocarbon (CFC) propellants due to environmental concerns is well under way. The hydrofluoroalkanes (HFAs) are effective substitutes for CFCs.
The disadvantages of pMDIs largely arise from the need for a propellant, which produces particles that travel very fast, generating a high-velocity cloud over a short period of time. This results in deposition of most of the emitted dose in the oropharynx.
An additional problem from the generation of a high-velocity cloud is that many patients are unable to co-ordinate actuation of the inhaler with inspiration, which is crucial for proper lung deposition; consequently they do not obtain optimal therapeutic benefit from their medication.
Devices for inhalation therapy: Dry powder inhalers (DPIs)
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Dry powder inhalers (DPIs) are devices that are breath-actuated, therefore requiring no co-ordination between device actuation and inhalation. The newer multi-dose DPIs deliver a greater percentage of the inhaled drug dose to the lungs compared with pMDIs.
However, drug particles that are fine enough to deposit in the lung are often difficult to handle in the manufacturing process. Such drugs have to go through an aggregation process involving binding the drug to a carrier (e.g. lactose). As the material passes through the device during inhalation, the drug must dissociate into single particles to be respirable; this depends on the inspiratory effort of the patient. Consequently, the proportion of the dose inhaled as fine particles varies considerably from patient to patient; a large fraction often remains bound to the carrier and deposits in the oropharynx.
Importantly, some powder formulations are extremely moisture-sensitive; absorption of moisture decreases the generation of fine particles.
Safety
IB/FEN via Respimat® SMI or CFC-MDI: Safety in adult asthmatics
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Overall, the safety profile of Respimat® SMI was comparable to that of the CFC-MDI.
As expected in an asthma population, the most common adverse events were related to the respiratory system.
The frequency of adverse events considered to be treatment-related was generally low across all groups. Most adverse events were of mild or moderate intensity.
There were no reports of paradoxical bronchoconstriction (PB) in patients using Respimat® SMI.
Vincken W, Bantje T, Middle MV, et al. Long-term efficacy and safety of ipratropium bromide plus fenoterol via Respimat® Soft Mist™ Inhaler (SMI) versus a pressurised metered dose inhaler in asthma. Clin Drug Invest 2004;
24: 17-28.
IB/FEN via Respimat® SMI or CFC-MDI: Safety in asthmatic children
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The safety profiles of IB/FEN 10/25 µg and 20/50 µg via Respimat® SMI were comparable to that of IB/FEN 40/100 µg via CFC-MDI.
The overall incidence rate of adverse events was higher in the IB/FEN 40/100 µg via CFC-MDI group (34%) than in the IB/FEN 10/25 µg (25%) and IB/FEN 20/50 µg (24%) via Respimat® SMI groups. However, no clinically relevant between-treatment differences were observed. Asthma exacerbation and coughing were the most frequent adverse events in all treatment groups and were slightly more common in those receiving IB/FEN via CFC-MDI (9.0% and 7.9%, respectively) than in the two Respimat® SMI groups (5.6-6.7%). Most adverse events were of mild or moderate intensity.
There were no spontaneous reports of PB.
von Berg A, Jeena PM, Soemantri PA, et al. Efficacy and safety of ipratropium bromide plus fenoterol inhaled via Respimat® Soft Mist™ Inhaler vs. a conventional metered dose inhaler plus spacer in children with asthma. Pediatr Pulmonol 2004;
37: 264-72.