THURSDAY, July 7 (HealthDay News) -- Patients with chronic obstructive pulmonary disease (COPD) tolerate indacaterol well, and have improved bronchodilation at 52 weeks, according to a study published in the July issue of Chest.
Kenneth R. Chapman, M.D., from the University of Toronto, and colleagues investigated the long-term safety of indacaterol in 415 patients with moderate to severe COPD who had completed a 26-week randomized study with indacaterol or placebo and were enrolled in an extension study. Participants were treated with 150 or 300 µg indacaterol per day, or placebo for a further 26 weeks. End points included trough forced expiratory volume in one second (FEV1) at 52 weeks, exacerbations, and health status as measured by the St. George Respiratory Questionnaire (SGRQ).
The investigators found that, on receiving 150 µg indacaterol, 300 µg, or placebo, 76, 77, and 68 percent of patients, respectively, experienced primarily mild to moderate adverse effects, and 10.4, 12.3, and 10.5 percent of patients experienced serious adverse effects, respectively. The effects of indacaterol on electrocardiography findings, serum potassium, and plasma glucose levels were not clinically significant. Patients receiving indacaterol had higher trough FEV1 during the study, while exacerbation rates, and as-needed albuterol (1.2 to 1.4 puffs/day) were significantly lower than in patients receiving placebo. There was no evidence of tolerance to the bronchodilator effect of indacaterol. Health status showed a marked improvement from baseline with a decrease of more than four units in the mean total SGRQ score.
"Once-daily indacaterol provided effective and sustained bronchodilation when given for one year to subjects with moderate to severe COPD, in association with decreased as-needed albuterol use and reduced exacerbations," the authors write.
Several of the study authors disclosed financial relationships with the pharmaceutical industry, including Novartis, which sponsored the study.
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