ABSTRACT
Background: Chronic obstructive pulmonary disease (COPD) is an airway disorder characterized by airflow limitation that is not fully reversible. Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β2-agonist bronchodilator recently approved in India for the treatment of chronic obstructive pulmonary disease (COPD). The aim of the present study was to investigate the efficacy and safety of indacaterol compared to twice-daily β2-agonist, salmeterol, as an active control. Methods: The present study was open, randomized parallel group comparison of two active treatment groups over a 12 week period. A total of 60 patients with moderate-to-severe COPD were randomised to treatment either with indacaterol (150 μg once daily) or with salmeterol (50 μg twice daily) and 51 (85%) patients completed the study. The efficacy parameters were change in FEV1, health related quality of life by measuring St George’s Respiratory Questionnaire (SGRQ) total score and severity of dyspnoea as measured by Transition Dyspnoea Index (TDI) score which were assessed at baseline first and at weeks 4, 8 and 12. Results: Indacaterol increased FEV1 at week 4 by 50 ml, at week 8 and at week 12 by 60 ml over salmeterol and the increase was highly significant (p<0.001) at all stages of the study. Both treatments improved health status (SGRQ total score) and dyspnoea (TDI score), with differences between them favouring indacaterol. Safety profiles were similar across the treatment groups, and both indacaterol and salmeterol were well tolerated without any severe adverse events. Conclusions: Once-daily treatment with 150 μg indacaterol had a significant and clinically relevant bronchodilator effect and improved health status and dyspnoea to a greater extent than twice-daily 50 μg salmeterol. Indacaterol should prove a useful addition in the treatment of patients with COPD.