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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: 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.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.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.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.

SUBMITTER: Kim CJ

PROVIDER: S-EPMC5459963 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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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.

Kim Cheong-Ju CJ Yoon Hyoung-Kyu HK Park Myung-Jae MJ Yoo Kwang-Ha KH Jung Ki-Suck KS Park Jeong-Woong JW Lim Seong Yong SY Shim Jae Jeong JJ Lee Yong Chul YC Kim Young-Sam YS Oh Yeon-Mok YM Kim Song S Yoo Chul-Gyu CG

International journal of chronic obstructive pulmonary disease 20170529

<h4>Background and objective</h4>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 a ...[more]

PMID: 28615931

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Project description:Purpose:This study investigated the effect of dual bronchodilation with the long-acting ?-receptor agonist/long-acting muscarinic antagonist combination, indacaterol/glycopyrronium (IND/GLY), on nighttime oxygenation, lung function, sleep quality, and symptoms in patients with moderate-to-severe COPD. Patients and methods:This was a 4-week, double-blind, multicenter, placebo-controlled, two-period crossover study. Patients were randomized in a 1:1 ratio to receive IND/GLY 110/50 µg once daily or matching placebo. The primary objective was to evaluate the effect of treatment with IND/GLY on mean nighttime oxygenation, compared with placebo. The secondary objective was to determine the time spent <90% in blood oxygen saturation (SpO2) compared with placebo. Exploratory objectives were to assess the effect of IND/GLY, compared with placebo, on sleep quality measured by the Medical Outcomes Study (MOS) Sleep Scale and the COPD and Asthma Sleep Impact Scale (CASIS) questionnaires and on symptoms assessed by COPD Assessment Test (CAT) questionnaire. Results:In total, 38 patients were randomized (n=22, IND/GLY; n=16, placebo). The change in nighttime oxygenation (SpO2) was similar, and there was a comparable difference in time spent <90% SpO2 between IND/GLY and placebo. Increases from baseline for the difference between IND/GLY and placebo for trough FEV1, FVC, and inspiratory capacity (P<0.05) were seen, with a corresponding reduction in residual volume and functional residual capacity (P<0.05). IND/GLY treatment showed an improvement in scores for CAT (P=0.0208), CASIS, and the MOS Sleep Scale measures, Sleep Problems Index I, Sleep Problems Index II (P=0.0315), Sleep Adequacy, Sleep Disturbance Scale, Somnolence Scale, and Short of Breath Scale (P=0.0031). Conclusion:In this study, IND/GLY 110/50 µg once daily improved symptoms, sleep quality, and lung function, but showed no effect on nighttime oxygenation in patients with moderate-to-severe COPD.

Dataset Information

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.

Publications

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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