| Low incidence of Paradoxical Bronchoconstriction with Bronchodilator Drugs administered by Respimat® Soft Mist Inhaler: Results of Phase II Single-Dose Crossover Studies (D.Koehler, D. Pavia, H. Dewberry, R. Hodder) |
Kohler D, Pavia D, Dewberry H, Hodder R. Low incidence of paradoxical bronchoconstriction with bronchodilator drugs administered by Respimat Soft Mist inhaler:results from phase II single-dose crossover studies. Respiration 2004; 71: 469-476.
This paper compares the incidence of paradocical bronchonconstriction when administering bronchodilator drugs via Respimat® SMI of a CFC-MDI in asthma and COPD patients. Pooled data from 9 phase II studies show a low incidence of adverse events indicative for paradoxical bronchoconstriction in patients using Respimat SMI and similar in nature to that seen when administering drugs to patients from pMDIs. |
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| Preference for novel soft mist inhaler over pMDI in patients with COPD |
Schuermann W. Schmidtmann S., Moroni P, Massey D, Qidan M. Respimat Soft Mist Inhaler versus hydrofluroalkane medered dose inhaler: patient preference and satisfaction. Treatm. Respir. Med. 2005; 4: 53-61
This study describes patients' experience regarding handling, satisfaction and preference of Respimat® Soft Mist™ Inhaler over pMDIs. The overall satisfaction for Respimat® SMI was extremely high. This resulted in a clear preference of Respimat® over the pMDIs. |
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| Increased lung deposition |
Freund BWJ, et al. The Respimat® system (BINEB®): a new approach to inhalation therapy.
J Aerosol Med 1997; 10: 246 (Abstract SV-5).
A discussion of the principle behind the
Respimat® Soft Mist™ Inhaler device. Studies demonstrate
that lung deposition is increased by a factor of 2.5-3 with Respimat® Soft Mist™ Inhaler compared with a CFC-MDI. |
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Pavia D. Efficacy and safety of inhalation therapy in Chronic Obstructive Pulmonary
Disease and asthma, Respirology 1997; 2(Suppl 1): S5-S10.
An overview of factors affecting inhaled drug delivery and the various devices currently in use (MDIs, DPIs, nebulizers).
Details of the ideal
aerosol drug delivery device are accompanied by Respimat® Soft Mist™ Inhaler. Data demonstrate its unique mechanism of action, and its superiority over MDIs in terms of drug deposition in the lung. |
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Newman SP. Use of gamma scintigraphy to evaluate the performance of new inhalers. J Aerosol Med 1999; 12(Suppl 1): S25-S31.
A review of four studies quantifying the amount of drug deposited in the lung with Respimat® SMI versus pMDI, with and without a spacer
device, using gamma scintigraphy.
Respimat® Soft Mist™ Inhaler more than doubles deposition in the lungs compared with
a pMDI and reduces oropharyngeal deposition. |
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| The target for new inhaler devices |
Latham D. Spraying it green. Pharmaceutical Visions 1998; Spring: 23-27.
An article discussing the switch from CFC to CFC-free inhalers from the perspective of the companies that were affected most by the regulations of the Montreal Protocol. |
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| Categorisation of the new, hand-held, liquid aerosol device Respimat® Soft Mist™Inhaler |
Denyer J, et al. New liquid drug aerosol devices for inhalation therapy.
Eur Respir Rev 2000; 10: 187-191.
The development of new liquid drug aerosol delivery systems, including Respimat® SMI, is discussed, along with the need for the European Respiratory Society (ERS) to redefine the term nebuliser. The current definition is a device to generate an aerosol from an aqueous drug, which is supplied separately. Respimat® Soft Mist™ Inhaler does this, but is closer to an MDI. The ERS needs to expand the definition of a nebuliser and provide clear information about the differences between devices. |
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| The innovative approach of Respimat® SMI compared to currently available inhalers |
Agnew JE. Introduction: Towards better delivery of inhaled medication.
J Aerosol Med 1999; 12(Suppl 1): S1-S2.
A short overview of the characteristics associated with current inhalation devices, including their propellants, and the
pressure from patients for better ways to manage their respiratory problems. A brief introduction to current research in
the area, including the search for alternative energy sources, using Respimat® SMI as an example. |
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Ganderton D. Targeted delivery of inhaled drugs: current challenges and future goals.
J Aerosol Med 1999; 12(Suppl 1): S3-S8.
A brief review of the advantages and disadvantages of MDIs, DPIs and nebulisers, highlighting the continuing need
to effectively target drugs to the lungs. The characteristics of the 'ideal' inhaler device required to achieve this are
discussed, along with a brief description of Respimat® Soft Mist™ Inhaler, a propellant-free inhaler in advanced development. |
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Dolovich M. New propellant-free technologies under investigation. J Aerosol Med 1999;
12(Suppl 1): S9-S17.
A review of the propellant-free technologies
under investigation for the delivery of aerosolized solutions- (adaptive aerosol
delivery devices, metered dose liquid inhalers including
Respimat® Soft Mist™ Inhaler,
and breath-actuated nebulizers) and dry powders (single capsule, bulk reservoir, or multidose devices) to the lung. |
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| The properties of the unique, slow-moving, long-lasting Soft Mist™ |
Zierenberg B. Optimizing the in-vitro performance of Respimat. J Aerosol Med 1999;
12(Suppl 1): S19-S24.
An overview of the milestones in the development of Respimat® Soft Mist™ Inhaler. Its mechanism of action is discussed, including its use of a coiled spring to replace propellants and the generation of a slow-moving aerosol of Soft Mist™, along with details of studies examining the size and velocity of the aerosol particles. |
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Ganderton D. Chairman's summary. J Aerosol Med 1999; 12(Suppl 1): S41-S42.
A brief overview of the objective of inhaler technology - a stationary or slow-moving cloud of particles generated in a
way that permits synchrony with slow inspiration by the patient - accompanied by details of how Respimat® Soft Mist™ Inhaler
fits these criteria. |
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Spallek et al. Optimizing nozzles for soft mist inhalers. Respiratory Drug Delivery VIII 2002, 375-378.
A study to find the ideal nozzle to generate a
Soft Mist™ of aerosolised particles from
Respimat® Soft Mist™ Inhaler. A nozzle in which two jets of aqueous drug solution impact each other was best suited to Respimat® Soft Mist™ Inhaler, taking into account the high mechanical robustness and the good results of nozzle reliability. |
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Hochrainer D, et al. Comparison of cloud velocities delivered from Respimat® Soft Mist™
Inhaler or MDIs. J Aerosol Med 2001; 14: 386 (Abstract P1-5).
A comparison of the cloud velocities and durations from Respimat® Soft Mist™ Inhaler with those from various MDIs,
using a video camera. Respimat® SMI produced a Soft Mist™, which was considerably slower and more prolonged
than the clouds produced by MDIs. The Soft Mist™ improved lung deposition and reduced oropharyngeal deposition. |
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| The properties of the unique high fine particle fraction of the Soft Mist™ |
Hochrainer D, et al. Evaporation and disposition of ethanol droplets from the Respimat®.
J Aerosol Med 1999; 12: 142 (Abstract 201).
Respimat® Soft Mist™ Inhaler delivers an aqueous or ethanolic drug solution. This study investigates how much
ethanol a patient can receive by deposition of droplets from inhaling one puff. A maximum of 4µl ethanol could be
deposited although, at a distance from the nozzle, the majority of drug particles are present without ethanol and
are so small that they can be inhaled into the lung. |
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Wachtel H, et al. Improved assessment of inhaler device performance using
laser diffraction. Respiratory Drug Delivery VIII 2002, 379-381.
A study investigating a new method - laser diffraction - of measuring particle size distribution of aqueous
formulations released from Respimat® SMI (a routine task during the development of new
formulations and devices). Laser diffraction and impactor (the GOLD standard method) correlated well, supporting the
use of laser diffraction from many routine investigations, since it offers substantial time savings. |
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