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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients
Respiratory Medicine, Volume 104, No. 10, Year 2010
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Description
In this randomised double-blind study, patients ≥40 years old with COPD, a smoking history of ≥10 pack-years, a pre-bronchodilator FEV1 of ≤60% predicted and an FEV1/FVC of ≤70% received tiotropium 5 μg or placebo via Respimat® inhaler once daily for 48 weeks. Other medications were permitted except inhaled anticholinergics. Co-primary endpoints were trough FEV1 and the time to first exacerbation. Adverse events were followed and vital status regularly assessed. In all, 3991 patients (mean age, 65 years [SD, 9 years]) were evaluable. Mean baseline FEV1 was 1.11 L (0.40 L) or 40% (12%) of predicted normal. Adjusted mean differences in trough FEV1 and trough FVC at Week 48 (tiotropium minus placebo) were 102 and 168 ml respectively (p < 0.0001, both). Tiotropium delayed time to first exacerbation relative to placebo (hazard ratio [HR], 0.69 [95% CI, 0.63-0.77]) and time to first hospital-treated exacerbation (HR, 0.73 [0.59-0.90]). SGRQ score at Week 48 was 2.9 units lower with tiotropium (p < 0.0001). Adverse and serious adverse events were balanced across treatment groups and similar in profile to previous tiotropium trials. The rate ratio for a major adverse cardiovascular event during the treatment period + 30 days was 1.12 (0.67-1.86). By the end of planned treatment (Day 337) 52 patients on tiotropium (incidence rate per 100 years, 2.94) and 38 on placebo (2.13) had died (HR = 1.38 [0.91-2.10]; p = 0.13). Lung function, exacerbations and quality of life were improved by tiotropium 5 μg Respimat® but a numerical imbalance was seen in all-cause mortality. The protocol is registered on the European Clinical Trials Database as trial number 2006-001009-27 and in the ClinicalTrials.gov database as NCT00387088. © 2010 Published by Elsevier Ltd.
Authors & Co-Authors
Bateman, E. D.
South Africa, Cape Town
University of Cape Town
Tashkin, Donald P.
United States, Los Angeles
David Geffen School of Medicine at Ucla
Siafakas, Nikolaos M.
Greece, Rethymnon
University of Crete
Dahl, Ronald
Denmark, Aarhus
Aarhus Universitetshospital
Towse, Lesley
United Kingdom, Bracknell
Boehringer Ingelheim Limited, uk
Massey, D.
United Kingdom, Bracknell
Boehringer Ingelheim Limited, uk
Pavia, Demetri
United Kingdom, Bracknell
Boehringer Ingelheim Limited, uk
Zhong, Nanshan
China, Guangzhou
Guangzhou Institute of Repiratory Disease
Statistics
Citations: 108
Authors: 8
Affiliations: 6
Identifiers
Doi:
10.1016/j.rmed.2010.06.004
ISSN:
09546111
Research Areas
Disability
Environmental
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study