Introduction: Bronchodilators represent the mainstay of symptomatic treatment for chronic obstructive pulmonary disease (COPD). The principal bronchodilator agents are β₂-agonists, anticholinergics and methylxanthines, used singly or in combination. Indacaterol is a novel long-acting β₂-agonist for maintenance bronchodilator treatment of airflow obstruction in patients with COPD, approved in December 2009 by the European Medicines Association, and recently by the US Food and Drug Administration. It is administered once daily and is delivered by means of a single-dose dry powder inhaler (SDDPI). In Europe, the recommended dose is 150 μg and the maximum dose is 300 μg, while in the US the recommended dose is 75 μg. Indacaterol shows evidence of a rapid onset of bronchodilation, and its bronchodilatory duration is sustained.

Areas covered: Numerous clinical studies have assessed the therapeutic effects of indacaterol in various physiologic parameters, as well as symptoms, disease progression, exacerbation rates, quality of life, safety and tolerability. This review summarises published evidence regarding the efficacy, tolerability and safety of indacaterol in regard to lung function and symptoms of COPD patients.

Expert opinion: Indacaterol, the novel once-daily β₂-agonist, has rapid and sustained bronchodilatory effect, showing excellent efficacy, tolerability and safety, as shown by all clinical trials so far.