TY - JOUR T1 - Effectiveness of indacaterol with or without tiotropium in patients with moderate or severe chronic obstructive pulmonary disease (COPD) - the GOLDEN II study JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P804 AU - Mihail Toumbis AU - Eirini Mitsiki AU - Dimosthenis Papapetrou AU - Konstantinos Marosis AU - Vasileios Gkoumas AU - Dionysis Spyratos AU - Konstantinos Kallergis AU - Panagiotis Demertzis AU - Despoina Zorpidou AU - Stylianos Michaelidis AU - Konstantinos Gourgoulianis Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P804.abstract N2 - Introduction: Lung function decline (FEV1) in COPD patients has been associated with increased mortality. According to GOLD 2013 bronchodilators are the recommended foundation treatment for COPD.Aim: To evaluate the effectiveness of indacaterol monotherapy and free combination with tiotropium in patients with COPD on FEV1, dyspnea (mMRC) and health status (EQ5D-VAS).Methods: GOLDEN II was a multicenter, non-interventional, observational study. Patients with moderate or severe COPD >40 years, available medical history on treatment with indacaterol, tiotropium or both no longer than 10 days prior to enrolment, could be recruited. Study duration was 3 months. Treatment effectiveness was recorded in two visits (Day 1; month 3).Results: Of 333 patients recruited, 299 completed the study; (84% male), mean age 68±10 years. Most patients had moderate and severe COPD (mean post-bronchodilator FEV1 55.9±14.7%, 61%GOLDΙΙ, 33%GOLDΙΙΙ) and dyspnea (mean mMRC 1.7±1.0); 41% were treated with indacaterol, 59% were under a free combination of indacaterol + tiotropium. On study completion, post-bronchodilation FEV1 improved from baseline (from 62±14% to 66±15% for the indacaterol group; from 52±14% to 55±14% for the indacaterol + tiotropium group, p<0.001) as did dyspnea (-0.2±0.7 and -0.3±0.8; p<0.001 respectively in mMRC) and health status (ΕQ5D-VAS from 68±19mm to 76±14mm; from 66±17mm to 71±16mm respectively, p<0.001).Conclusions: In these patients with moderate to severe COPD, both indacaterol and the free combination of indacaterol + tiotropium improved FEV1, reduced dyspnea and improved the health status after 3 months of treatment. ER -