Back to Browse Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 5

Efficacy and safety of tiotropium Respimat® SMI in COPD in two 1-year randomized studies

Authors Eric Bateman, Dave Singh, David Smith, et al

Published Date June 2010 Volume 2010:5 Pages 197—208

DOI http://dx.doi.org/10.2147/COPD.S9616

Published 9 June 2010

Eric Bateman1, Dave Singh2, David Smith3, Bernd Disse4, Lesley Towse5, Dan Massey5, Jon Blatchford5, Demetri Pavia5, Rick Hodder6

1Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa; 2University Hospital of South Manchester Foundation Trust, University of Manchester, Manchester, UK; 3North Bristol Lung Centre, Southmead Hospital, Bristol, UK; 4Boehringer Ingelheim, GmbH, Ingelheim, Germany; 5Boehringer Ingelheim, Ltd., Bracknell, Berkshire, UK; 6Divisions of Pulmonary and Critical Care Medicine, University of Ottawa, Ottawa, Ontario, Canada

Abstract: Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 μg versus placebo, inhaled via the Respimat® Soft MistTM Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV1 response, Mahler Transition Dyspnea Index [TDI] and St George’s Respiratory Questionnaire scores all at week 48, and COPD exacerbations per patient-year). A total of 1990 patients with COPD participated (mean FEV1: 1.09 L). The mean trough FEV1 response of tiotropium 5 or 10 μg relative to placebo was 127 or 150 mL, respectively (both P < 0.0001). The COPD exacerbation rate was significantly lower with tiotropium 5 μg (RR = 0.78; P = 0.002) and tiotropium 10 μg (RR = 0.73; P = 0.0008); the health-related quality of life and Mahler TDI co-primary endpoints were significantly improved with both doses (both P < 0.0001). Adverse events were generally balanced except anticholinergic class effects, which were more frequent with active treatment. Fatal events occurred in 2.4% (5 μg), 2.7% (10 μg), and 1.6% (placebo) of patients; these differences were not significant. Tiotropium Respimat® SMI 5 μg demonstrated sustained improvements in patients with COPD relative to placebo and similar to the 10 μg dose but with a lower frequency of anticholinergic adverse events.
Keywords: COPD, exacerbations, FEV1, quality of life, Respimat®, tiotropium

Download Article [PDF] 

Creative Commons License This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php

Other article by this author:

Risk assessment and aspirin use in Asian and Western populations

Runlin Gao, Xiaoying Li

Vascular Health and Risk Management 2010, 6:943-956

Published Date: 14 October 2010

Readers of this article also read:

Epidemiology of nonfatal stroke and transient ischemic attack in Al-Kharga District, New Valley, Egypt

Farghaly WM, El-Tallawy HN, Shehata GA, Rageh TA, Abdel-Hakeem NM, Elhamed MA, Al-Fawal BM, Badry R

Neuropsychiatric Disease and Treatment 2013, 9:1785-1790

Published Date: 18 November 2013

Nonselective ß-blocker propranolol for orbital and periorbital hemangiomas in infants: a new first-line of treatment?

El-Essawy R, Galal R, Abdelbaki S

Clinical Ophthalmology 2011, 5:1639-1644

Published Date: 18 November 2011

Filament formation associated with spirochetal infection: a comparative approach to Morgellons disease

Middelveen MJ, Stricker RB

Clinical, Cosmetic and Investigational Dermatology 2011, 4:167-177

Published Date: 14 November 2011

Everolimus-eluting stents: update on current clinical studies

Allocco DJ, Joshi AA, Dawkins KD

Medical Devices: Evidence and Research 2011, 4:91-98

Published Date: 26 July 2011

Corrigendum: Softec HD hydrophilic acrylic intraocular lens: biocompatibility and precision

Espandar L, Sikder S, Moshirfar M

Clinical Ophthalmology 2011, 5:159-160

Published Date: 6 February 2011

Eggshell membrane: A possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies

Kevin J Ruff, Dale P DeVore, Michael D Leu, Mark A Robinson

Clinical Interventions in Aging 2009, 4:235-240

Published Date: 18 May 2009

Prevention of atherosclerosis in patients living with HIV

Ferruccio De Lorenzo, Marta Boffito, Sophie Collot-Teixeira, Brian Gazzard, John L McGregor, Kevin Shotliff, Han Xiao

Vascular Health and Risk Management 2009, 5:287-300

Published Date: 26 March 2009