Int J Chron Obstruct Pulmon Dis. 2017;12:1589-1596.

Inhaled indacaterol for the treatment of COPD patients with destroyed lung by tuberculosis and moderate-to-severe airflow limitation: results from the randomized INFINITY study.

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제1저자 김정주 · 교신저자 유철규

PMID 28615931 PMC5459963 DOI 10.2147/COPD.S128750 IF 4.1 호흡기내과

소속 (13)

Department of Internal Medicine, National Health Insurance System Ilsan Hospital, Koyang.
Division of Pulmonology, Department of Internal Medicine, St Mary's Hospital, College of Medicine, The Catholic University of Korea.
Division of Respiratory and Critical Care Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul.
Department of Internal Medicine, Konkuk University School of Medicine, Gwangjin-gu.
Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, Anyang-si.
Division of Pulmonary and Allergy Medicine, Gachon University Gil Medical Center, Incheon.
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine.
Department of Internal Medicine, Korea University College of Medicine, Seoul.
Department of Internal Medicine and Research Center for Pulmonary Disorders, Chonbuk National University Medical School, Jeonbuk.
Department of Internal Medicine, Yonsei University College of Medicine.
Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine.
Clinical Development and Medical Affairs, Novartis Korea Ltd., Seoul.
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND AND OBJECTIVE Pulmonary tuberculosis (TB) is a risk factor for chronic obstructive pulmonary disease (COPD); however, few clinical studies have investigated treatment effectiveness in COPD patients with destroyed lung by TB. The Indacaterol effectiveness in COPD patients with Tuberculosis history (INFINITY) study assessed the efficacy and safety of once-daily inhaled indacaterol 150 µg for the treatment of Korean COPD patients with destroyed lung by TB and moderate-to-severe airflow limitation.

METHODS This was a multicenter, double-blind, parallel-group study, in which eligible patients were randomized (1:1) to receive either once-daily indacaterol 150 µg or placebo for 8 weeks. The primary efficacy endpoint was change from baseline in trough forced expiratory volume in 1 s at Week 8; the secondary endpoints included changes in transition dyspnea index score and St George's Respiratory Questionnaire for COPD score at Week 8. Safety was evaluated over 8 weeks.

RESULTS Of the 136 patients randomized, 119 (87.5%) completed the study treatment. At Week 8, indacaterol significantly improved trough forced expiratory volume in 1 s versus placebo (treatment difference [TD] 140 mL, P<0.001). Statistically significant improvement in transition dyspnea index score (TD =0.78, P<0.05) and numerical improvement in St George's Respiratory Questionnaire for COPD score (TD =-2.36, P=0.3563) were observed with indacaterol versus placebo at Week 8. Incidence of adverse events was comparable between the treatment groups.

CONCLUSION Indacaterol provided significantly superior bronchodilation, significant improvement in breathlessness and improved health status with comparable safety versus placebo in Korean COPD patients with destroyed lung by TB and moderate-to-severe airflow limitation.

Keywords

COPDairflow limitationindacaterollungstuberculosis

Figures

**Figure 1** Study design. **Abbreviation:** o.d., once daily.

**Figure 3** Change from baseline in trough FEV₁ at Week 8 (ITT set and PP set). **Notes:** Data are presented as LS means. Δ, Treatment difference LS mean. **Abbreviations:** CI, confidence interval; FEV₁, forced expiratory volume in 1 s; ITT, intent-to-treat; LS, least squares; PP, per protocol; SE, standard error.

**Figure 4** (A) Proportion of patients with a clinically important improvement from baseline in TDI total score (≥1 point; ITT and PP population). (B) Proportion of patients achieving MCID in St George’s Respiratory Questionnaire score. **Notes:** Data for TDI total score are least squares means. *P<0.05 and **P<0.01 versus placebo. **Abbreviations:** ITT, intent-to-treat; MCID, minimal clinically important difference; PP, per protocol; TDI, transition dyspnea index.

그림 출처: PubMed Central 공개 논문 (PMC5459963)

Conflict of interest statement

Disclosure Song Kim is a Novartis employee. The other authors report no conflicts of interest in this work.

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