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      Clinical effectiveness of the Respimat ® inhaler device in managing chronic obstructive pulmonary disease: evidence when compared with other handheld inhaler devices

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          Abstract

          Objectives:

          Medication for the management of chronic obstructive pulmonary disease (COPD) may be delivered by a number of different inhaler devices. This study was undertaken to determine the clinical effectiveness of the Respimat ® handheld inhaler device compared with other handheld inhaler devices for the delivery of medication in stable COPD.

          Methodology:

          A systematic review of high-quality randomized controlled clinical trials comparing Respimat with other inhaler devices using the same medication was performed. Studies were searched for in the Cochrane Central Register of Controlled Trials as well as other relevant electronic databases. Manufacturers of inhaled COPD medication were also contacted for potential trials.

          Results:

          Seven studies of high methodological quality with 3813 participants were included in the review. Three trials used Handihaler ® as the comparator inhaler, three used a chlorofluorocarbon metered-dose inhaler (CFC-MDI), and one trial used a hydroflouroalkane (HFA)-MDI. When Respimat was compared with Handihaler, the following reported outcomes were not significantly different: trough forced expiratory volume in 1 second (FEV 1) (weighted mean difference [WMD] 0.01 L; P = 0.14), trough forced vital capacity (FVC) (WMD 0.001 L: P = 0.88), peak FEV 1 (WMD 0.01 L: P = 0.08), peak FVC (WMD 0.01 L: P = 0.55), morning peak expiratory flow rate (PEFR) (WMD 5.06 L/min: P = 0.08), and evening PEFR (WMD 4.39 L/min: P = 0.15). Furthermore, there were no differences when Respimat was compared with Handihaler for risk of exacerbations (relative risk [RR] 0.94: P = 0.81), dry mouth (RR 1.57: P = 0.34), or nasopharyngitis (RR 1.42: P = 0.22). For Respimat compared with CFC-MDI, the only outcome for which data were available for meta-analysis was exacerbations, which were not significantly different (RR 1.20: P = 0.12). In addition, five trials with 2136 patients showed that there was no difference in risk of exacerbations or nasopharyngitis when Respimat was compared with all other handheld inhaler devices (RR 1.18: P = 0.13 and RR 1.33: P = 0.19, respectively). None of the clinical outcome measures reported was significantly different when the same, higher, or lower doses of medication were used in the inhaler devices being compared. Unfortunately, none of the included trials reported mortality as an outcome measure.

          Conclusions:

          Evidence from high-quality trials published to date suggests that the Respimat inhaler does not provide any additional clinical benefit to that provided by other inhaler devices in the management of COPD. Although in vitro studies have reported differences between the Respimat inhaler device and other handheld devices, we found no difference in any clinical outcome measures, including lung function and adverse events. Although recent reports have highlighted concerns of increased mortality with the Respimat inhaler device, none of the included trials reported mortality as an outcome. Only a small number of trials reported data that could be used in this systematic review, and a limited number of studies have been published that compare Respimat with other inhaler devices using the same drug and strength. Therefore, further trials comparing Respimat with other handheld inhaler devices using the same drug and dose are required before firm conclusions can be drawn. The concern with increased mortality with Respimat use should be investigated urgently.

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          Most cited references 35

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          A one-year trial of tiotropium Respimat plus usual therapy in COPD patients.

           E Bateman,  L Towse,  R Dahl (2010)
          In this randomised double-blind study, patients >or=40 years old with COPD, a smoking history of >or=10 pack-years, a pre-bronchodilator FEV(1) of
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            Patient preferences for inhaler devices in chronic obstructive pulmonary disease: experience with Respimat® Soft Mist™ Inhaler

            Current guidelines for the management of chronic obstructive pulmonary disease (COPD) recommend the regular use of inhaled bronchodilator therapy in order to relieve symptoms and prevent exacerbations. A variety of inhaler devices are currently available to COPD patients, and the choice of device is an important consideration because it can influence patients’ adherence to treatment, and thus potentially affect the long-term outcome. The Respimat® Soft Mist™ Inhaler (SMI) generates a slow-moving aerosol with a high fine particle fraction, resulting in deposition of a higher proportion of the dose in the lungs than pressurized metered-dose inhalers (pMDIs) or some dry powder inhalers (DPIs). We review clinical studies of inhaler satisfaction and preference comparing Respimat® SMI against other inhalers in COPD patients. Using objective and validated patient satisfaction instruments, Respimat® SMI was consistently shown to be well accepted by COPD patients, largely due to its inhalation and handling characteristics. In comparative studies with pMDIs, the patient total satisfaction score with Respimat® SMI was statistically and clinically significantly higher than with the pMDI. In comparative studies with DPIs, the total satisfaction score was statistically significantly higher than for the Turbuhaler® DPI, but only the performance domain of satisfaction was clinically significantly higher for Respimat® SMI. Whether the observed higher levels of patient satisfaction reported with Respimat® SMI might be expected to result in improved adherence to therapy and thus provide benefits consistent with those recently shown to be associated with sustained bronchodilator treatment in patients with COPD remains to be proven.
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              Improving adherence with inhaler therapy in COPD

              Chronic obstructive pulmonary disease (COPD) is a major public health problem, associated with considerable morbidity and health care costs. The global burden of COPD morbidity is predicted to rise substantially in the coming decade, but could be moderated by better use of existing management strategies. Smoking cessation, medication therapy, and pulmonary rehabilitation have all been shown to diminish morbidity and improve patient outcomes. But each of these strategies requires adherence. Adherence is crucial for optimizing clinical outcomes in COPD, with nonadherence resulting in a significant health and economic burden. Suboptimal medication adherence is common among COPD patients, due to a number of factors that involve the medication, the delivery device, the patient, and the health professionals caring for the patient. Lack of medication adherence needs to be identified and addressed by using simplified treatment regimens, increasing patient knowledge about self-management, and enhancing provider skills in patient education, communication, and adherence counseling. This article reports some of the challenges of medication nonadherence faced by the clinician in the management of COPD, and suggests ways to evaluate and improve adherence effectively in primary care.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2011
                2011
                02 February 2011
                : 6
                : 129-139
                Affiliations
                [1 ]School of Health and Social Services, Massey University, Auckland, New Zealand;
                [2 ]Department of Physical Therapy, School of Medicine, University of São Paulo, Brazil;
                [3 ]York Hospitals NHS Foundation Trust, York Hospital, York, UK
                Author notes
                Correspondence: Felix SF Ram, School of Health and Social Services, Massey University, Private Bag 102-904, North Shore Mail Centre, Auckland, New Zealand, Tel +64 9 414 0800 extn 9066, Fax +64 9 414 8165, Email fsfram@ 123456yahoo.co.uk
                Article
                copd-6-129
                10.2147/COPD.S8092
                3064421
                21468167
                © 2011 Ram et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Categories
                Review

                Respiratory medicine

                respimat, handheld inhaler devices, aerosol cloud, copd

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