Inhaled Corticosteroid use and the Risk of Pneumonia and COPD Exacerbations in the UPLIFT Study.

"Conflict of interest JBM has received honoraria for speaking and financial support to attend meetings/ advisory boards from Wyeth, Chiesi, Pfizer, MSD, Boerhinger Ingelheim, Teva, GlaxoSmithKline, Napp, Almirall, AstraZeneca and Novartis Pharmaceuticals UK. ASR has no declarations. AHM has received for speaking and financial support to attend meetings/ advisory boards and grants from Boerhinger Ingelheim, Chiesi, Novartis Pharmaceuticals UK, Almirall, Astra Zeneca, GlaxoSmithKline, Reckitt Benckiser, Nexus Communications Group, Pfizer Ltd, Bayer plc, Infirst Healthcare, Afferent Pharmaceuticals Inc, Philips Home Healthcare Solutions, Nycomed, Aerocrine AB, Roche, Genentech, ICON and Patara Pharma."

"Funding No funding was acquired for the work in this manuscript."

"The study designs, recruitment criteria and procedures of the UPLIFT studies have been previously reported (UPLIFT clinical Trial registration: NCT00144339) []. Briefly, this was a multi-centre 4-year double-blind, parallel-group study in COPD patients with moderate-to-severe airflow limitation randomised to placebo or tiotropium 18 µg once daily. The two co-primary endpoints were the annual rate of decline in pre-bronchodilation forced expiratory volume in 1 s (FEV1) and the post-bronchodilator FEV1 after 30 days of randomisation to the completion of the study. Importantly, the subjects were permitted guideline-recommended therapies other than the study drug (tiotropium or placebo) and other than any alternative anti-cholinergic therapies. All subjects were ≥40 years of age, had a diagnosis of COPD, smoked for ≥10 pack years, were not on long-term oxygen therapy and had not had an exacerbation of COPD or respiratory infection within the last 4 weeks of screening. Compliance with Ethical Standards: Conflict of interestJBM has received honoraria for speaking and financial support to attend meetings/ advisory boards from Wyeth, Chiesi, Pfizer, MSD, Boerhinger Ingelheim, Teva, GlaxoSmithKline, Napp, Almirall, AstraZeneca and Novartis Pharmaceuticals UK. ASR has no declarations. AHM has received for speaking and financial support to attend meetings/ advisory boards and grants from Boerhinger Ingelheim, Chiesi, Novartis Pharmaceuticals UK, Almirall, Astra Zeneca, GlaxoSmithKline, Reckitt Benckiser, Nexus Communications Group, Pfizer Ltd, Bayer plc, Infirst Healthcare, Afferent Pharmaceuticals Inc, Philips Home Healthcare Solutions, Nycomed, Aerocrine AB, Roche, Genentech, ICON and Patara Pharma.: Ethical ApprovalAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. (UPLIFT clinical Trial registration NCT00144339)."