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Indacaterol Produces Effective Bronchodilation in Patients With COPD During 1 Year of Treatment: Presented at CHEST 2009

By Betty S. Riggs

SAN DIEGO -- November 6, 2009 -- One year of treatment with indacaterol for chronic obstructive pulmonary disease (COPD) produces clinically important bronchodilation with few side effects, researchers stated here at CHEST 2009, the annual meeting of the American College of Chest Physicians.

Stephen I. Rennard, MD, Pulmonary and Critical Care Section, University of Nebraska Medical Center, Omaha, Nebraska, and colleagues reported their findings on November 2.

The study was the third stage of a 3-part adaptive, seamless, randomised, double-blind, parallel-group study of indacaterol. Based on results of the first stage, 2 doses of indacaterol (150 and 300 mcg QD) were evaluated for efficacy and safety in stages 2 and 3.

The primary objective of stage 3 was to evaluate safety. Safety assessments included adverse events (AEs), vital signs, electrocardiograms, and laboratory evaluations. The secondary objective was to assess the efficacy of indacaterol. Efficacy assessments included trough (defined as 24-hours post dose) forced expiratory volume in 1 second (FEV₁), health status as measured by the St. George's Respiratory Questionnaire (SGRQ), exacerbations of COPD, and use of albuterol as a rescue medication.

Patients with moderate to severe COPD were included in the study. Patients with a history of asthma were excluded. A total of 144 patients were treated with indacaterol 150 mcg QD, 146 were treated with indacaterol 300 mcg QD, and 124 patients were treated with placebo.

The majority of patients were male in all groups, and the mean FEV₁ at baseline was 1.44, 1.50, and 1.54 L in the indacaterol 150-mcg group, the indacaterol 300-mcg group, and the placebo group, respectively.

Of those enrolled in stage 3, 88% completed the study. After 52 weeks, the difference in trough FEV₁ in the groups treated with indacaterol 150 or 300 mcg compared with placebo was 170 and 180 mL, respectively (P < .001 for both groups).

In both indacaterol groups, the SGRQ improved more than in the placebo group, reaching statistical significance only at weeks 26 and 44. Both indacaterol groups had significantly lower use of rescue albuterol over 52 weeks (P < .001 vs placebo) and significantly lower exacerbation rates (P < .05 vs placebo).

The overall incidence of AEs was 77.1%, 76.7%, and 68.5% in the 150-mcg, 300-mcg, and placebo group, respectively, with an incidence of serious AEs of 10.4%, 13.0%, and 10.5%, respectively. There were 2 deaths, 1 in the placebo group and 1 in the indacaterol 300-mcg group, both due to myocardial infarction.

There were no important differences in incidence of QTc prolongation in patients treated with indacaterol 150 or 300 mcg or placebo. The frequency of changes in serum potassium values from normal at study start to low during the 52-week treatment period was 4.2%, 8.9%, and 9.7% for the 150-mcg, 300-mcg, and the placebo group, respectively.

Funding for this study was provided by Novartis.

[Presentation title: Once-Daily Indacaterol Provides Effective Bronchodilation Over 1 Year of Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)]

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