PMID- 28615931 OWN - NLM STAT- MEDLINE DCOM- 20180409 LR - 20220409 IS - 1178-2005 (Electronic) IS - 1176-9106 (Print) IS - 1176-9106 (Linking) VI - 12 DP - 2017 TI - 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. PG - 1589-1596 LID - 10.2147/COPD.S128750 [doi] AB - 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 microg 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 microg 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. FAU - Kim, Cheong-Ju AU - Kim CJ AD - Department of Internal Medicine, National Health Insurance System Ilsan Hospital, Koyang. FAU - Yoon, Hyoung-Kyu AU - Yoon HK AD - Division of Pulmonology, Department of Internal Medicine, St Mary's Hospital, College of Medicine, The Catholic University of Korea. FAU - Park, Myung-Jae AU - Park MJ AD - Division of Respiratory and Critical Care Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul. FAU - Yoo, Kwang-Ha AU - Yoo KH AD - Department of Internal Medicine, Konkuk University School of Medicine, Gwangjin-gu. FAU - Jung, Ki-Suck AU - Jung KS AD - Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, Anyang-si. FAU - Park, Jeong-Woong AU - Park JW AD - Division of Pulmonary and Allergy Medicine, Gachon University Gil Medical Center, Incheon. FAU - Lim, Seong Yong AU - Lim SY AD - Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine. FAU - Shim, Jae Jeong AU - Shim JJ AD - Department of Internal Medicine, Korea University College of Medicine, Seoul. FAU - Lee, Yong Chul AU - Lee YC AD - Department of Internal Medicine and Research Center for Pulmonary Disorders, Chonbuk National University Medical School, Jeonbuk. FAU - Kim, Young-Sam AU - Kim YS AD - Department of Internal Medicine, Yonsei University College of Medicine. FAU - Oh, Yeon-Mok AU - Oh YM AD - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine. FAU - Kim, Song AU - Kim S AD - Clinical Development and Medical Affairs, Novartis Korea Ltd., Seoul. FAU - Yoo, Chul-Gyu AU - Yoo CG AD - Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170529 PL - New Zealand TA - Int J Chron Obstruct Pulmon Dis JT - International journal of chronic obstructive pulmonary disease JID - 101273481 RN - 0 (Adrenergic beta-2 Receptor Agonists) RN - 0 (Bronchodilator Agents) RN - 0 (Indans) RN - 0 (Quinolones) RN - 8OR09251MQ (indacaterol) SB - IM MH - Administration, Inhalation MH - Adrenergic beta-2 Receptor Agonists/*administration & dosage/adverse effects MH - Aged MH - Bronchodilator Agents/*administration & dosage/adverse effects MH - Double-Blind Method MH - Female MH - Forced Expiratory Volume MH - Health Status MH - Humans MH - Indans/*administration & dosage/adverse effects MH - Lung/*drug effects/physiopathology MH - Male MH - Middle Aged MH - Pulmonary Disease, Chronic Obstructive/diagnosis/*drug therapy/ethnology/physiopathology MH - Quinolones/*administration & dosage/adverse effects MH - Recovery of Function MH - Republic of Korea MH - Severity of Illness Index MH - Time Factors MH - Treatment Outcome MH - Tuberculosis, Pulmonary/*complications/diagnosis/physiopathology PMC - PMC5459963 OTO - NOTNLM OT - COPD OT - airflow limitation OT - indacaterol OT - lungs OT - tuberculosis COIS- Disclosure Song Kim is a Novartis employee. The other authors report no conflicts of interest in this work. EDAT- 2017/06/16 06:00 MHDA- 2018/04/10 06:00 PMCR- 2017/05/29 CRDT- 2017/06/16 06:00 PHST- 2017/06/16 06:00 [entrez] PHST- 2017/06/16 06:00 [pubmed] PHST- 2018/04/10 06:00 [medline] PHST- 2017/05/29 00:00 [pmc-release] AID - copd-12-1589 [pii] AID - 10.2147/COPD.S128750 [doi] PST - epublish SO - Int J Chron Obstruct Pulmon Dis. 2017 May 29;12:1589-1596. doi: 10.2147/COPD.S128750. eCollection 2017.