Phase III Clinical Efficacy of Indacaterol: Patient-Centered Outcomes

Abstract

International guidelines for the treatment of patients with chronic obstructive pulmonary disease (COPD) state that effective management should relieve symptoms, improve health status, prevent exacerbations, and improve exercise tolerance. In randomized placebo-controlled trials evaluating once-a-day indacaterol over 26–52 weeks, valid, reliable, and responsive instruments/methods were used to quantify the impact of treatment on patient outcomes. Compared with placebo treatment, both 150 and 300 μg doses of indacaterol provided significant and clinically meaningful improvements in dyspnea as measured by the Transition Dyspnea Index. Analyses showed that as-needed use of salbutamol, an indirect assessment of the efficacy of therapy on relief of dyspnea, was significantly lower with 150 and 300 μg doses of indacaterol than with placebo. With 150 and 300 μg doses of indacaterol, there were significant improvements in health status, as measured by the St. George’s Respiratory Questionnaire, relative to placebo therapy. In two of three randomized trials, the differences in the St. George’s Respiratory Questionnaire between indacaterol and placebo achieved the minimal important difference of −4 U. Time to first exacerbation was significantly decreased with 150 and 300 μg doses of indacaterol compared with placebo. In two randomized trials published as abstracts, the 300 μg dose of indacaterol significantly improved exercise endurance times on the cycle ergometer (by 88 and 111 s; p < 0.05) and significantly increased inspiratory capacity at end-exercise (by 280 and 317 ml; p < 0.05) compared with placebo. These overall findings demonstrate the clinical efficacy of indacaterol on patient-centered outcomes.