Assessing efficacy of indacaterol in moderate and severe COPD patients: A 12-week study in an Asian population

Yasuo To, Masaharu Kinoshita, Sang Haak Lee, Liang Wen Hang, Masakazu Ichinose, Yoshinosuke Fukuchi, Tetsuji Kitawaki, Naoko Okino, Niyati Prasad, David Lawrence, Benjamin Kramer

研究成果: Article査読

8 被引用数 (Scopus)

抄録

Introduction: This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β2-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan). Methods: Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV1 (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected. Results: Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol-placebo differences in trough FEV1 at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior (p < 0.001) for indacaterol (150 μg, 300 μg) versus placebo in the two subgroups [0.19L, 0.20L (moderate); 0.15L, 0.19L (severe) respectively]. LSM TDI scores for both indacaterol doses versus placebo in both subgroups were statistically superior (p < 0.05) and clinically meaningful (≥1 unit). Both indacaterol doses showed improvements in LSM SGRQ total scores at Week 12 which exceeded the MCID (4 units) versus placebo in both subgroups, with indacaterol 300 μg-placebo difference in the severe subgroup being statistically significant (p < 0.01). Overall incidence of adverse events was lower with indacaterol than with placebo across both subgroups. Conclusions: Indacaterol demonstrated clinically relevant improvements versus placebo in lung function, dyspnea and health status in Asian COPD patients irrespective of disease severity. Clinical Trials Identifier: NCT00794157.

本文言語English
ページ(範囲)1715-1721
ページ数7
ジャーナルRespiratory Medicine
106
12
DOI
出版ステータスPublished - 2012 12

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

フィンガープリント 「Assessing efficacy of indacaterol in moderate and severe COPD patients: A 12-week study in an Asian population」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル