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

Abstract

Cheong-Ju Kim,1 Hyoung-Kyu Yoon,2 Myung-Jae Park,3 Kwang-Ha Yoo,4 Ki-Suck Jung,5 Jeong-Woong Park,6 Seong Yong Lim,7 Jae Jeong Shim,8 Yong Chul Lee,9 Young-Sam Kim,10 Yeon-Mok Oh,11 Song Kim,12 Chul-Gyu Yoo13 1Department of Internal Medicine, National Health Insurance System Ilsan Hospital, Koyang, 2Division of Pulmonology, Department of Internal Medicine, St Mary’s Hospital, College of Medicine, The Catholic University of Korea, 3Division of Respiratory and Critical Care Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, 4Department of Internal Medicine, Konkuk University School of Medicine, Gwangjin-gu, 5Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, Anyang-si, 6Division of Pulmonary and Allergy Medicine, Gachon University Gil Medical Center, Incheon, 7Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 8Department of Internal Medicine, Korea University College of Medicine, Seoul, 9Department of Internal Medicine and Research Center for Pulmonary Disorders, Chonbuk National University Medical School, Jeonbuk, 10Department of Internal Medicine, Yonsei University College of Medicine, 11Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 12Clinical Development and Medical Affairs, Novartis Korea Ltd., Seoul, 13Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea 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: indacaterol, COPD, tuberculosis, airflow limitation, lungs

Keywords

• Indacaterol
• COPD
• Tuberculosis
• Airflow limitation
• Lungs