O R I G I N A L R E S E A R C H Outcomes in COPD patients receiving tiotropium or salmeterol plus treatment with inhaled corticosteroids Richard Hodder1 Steven Kesten2 Shailendra Menjoge2 Klaus Viel3 1Divisions of Pulmonary and Critical Care Medicine, University of Ottawa, Canada; 2Boehringer Ingelheim, Ridgefield, Connecticut; 3Boehringer Ingelheim, Ingelheim, Germany Correspondence: Richard Hodder The Ottawa Hospital, 1053 Carling Avenue, Ottawa, Ontario, Canada Tel +1 613 761 4130 Fax +1 613 761 4152 Email rhodder@ottawahospital.on.ca Abstract: Patients with COPD are frequently prescribed inhaled corticosteroids (ICS); however, it is unclear whether the treatment with ICS might modify responses to inhaled bronchodilators. Two 6-month, randomized, placebo-controlled, double-blind, double-dummy, parallel-group studies of tiotropium 18 μg once daily, compared with salmeterol, 50 μg bid, had been conducted in patients with moderate-to-severe COPD. Efﬁcacy was assessed by spirometry, transition dyspnea index (TDI), St. George´s Respiratory Questionnaire (SGRQ), and exacerbations. Data from both studies were combined to form subgroups with regard to concurrent use of ICS. 796 patients receiving ICS were separately analyzed from 390 patients not receiving ICS. Mean age was 64 years, and pre-bronchodilator FEV1 was 1.06 L (ICS group) and 1.13 L (non-ICS group). Both bronchodilators increased morning mean + SE pre-dose FEV1 compared with placebo (ICS groups: tiotropium 110 + 20 mL, salmeterol 80 + 20 mL; non-ICS groups: tiotropium 150 + 30 mL, salmeterol 110 + 30 mL; p > 0.05 for tiotropium vs salmeterol). Improvements in TDI and SGRQ and frequency of exacerbations also tended to be more profound for tiotropium. Treat- ment with tiotropium in patients with moderate-to-severe COPD was superior to salmeterol in lung function, irrespective of concurrent use of ICS. Keywords: chronic obstructive pulmonary disease, inhaled corticosteroids, salmeterol, tiotro- pium, ﬂuticasone Introduction Chronic obstructive pulmonary disease (COPD) is characterized by a chronic pro- gressive deterioration in lung function and commonly results in dyspnea on activity, and impaired health status. In addition, periodic worsenings of the disease, referred to as exacerbations, occur with increasing frequency as the disease advances and are felt to adversely affect health status and to hasten the already accelerated decline in lung function seen in COPD patients (Seemungal et al 1998; Kanner et al 2001; Donaldson et al 2002). COPD guidelines currently advocate aggressive smoking cessation, certain non-pharmacologic management strategies such as exercise and pulmonary rehabilitation, and a stepped approach to pharmacotherapy. The latter includes initial treatment with short-acting bronchodilators, progressing to the addi- tion of long-acting anticholinergic bronchodilators or long-acting beta2-adrenergic bronchodilators, or both, for patients with more advanced airway obstruction and persisting symptoms. In contrast to current asthma guidelines, where inhaled corticosteroids (ICS) are central to therapy of all patients with regular symptoms (GINA 1995), current COPD-guidelines are more cautious regarding the role of ICS, recommending their use only in symptomatic COPD patients with a documented spirometric or clinical response to ICS, or in those patients with an FEV <50% predicted and who suffer 1 International Journal of COPD 2007:2(2) 157–167 © 2007 Dove Medical Press Limited. All rights reserved 157