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

Cheong Ju Kim, Hyoung Kyu Yoon, Myung Jae Park, Kwang Ha Yoo, Ki Suck Jung, Jeong Woong Park, Seong Yong Lim, Jae Jeong Shim, Yong Chul Lee, Young Sam Kim, Yeon Mok Oh, Song Kim, Chul Gyu Yoo

Research output: Contribution to journalArticle

10 Citations (Scopus)

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 (treat-ment 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.

Original languageEnglish
Pages (from-to)1589-1596
Number of pages8
JournalInternational Journal of COPD
Volume12
DOIs
Publication statusPublished - 2017 May 29

Fingerprint

Chronic Obstructive Pulmonary Disease
Tuberculosis
Lung
Placebos
Dyspnea
Forced Expiratory Volume
Safety
Therapeutics
indacaterol
Pulmonary Tuberculosis
Health Status
Incidence

Keywords

  • Airflow limitation
  • COPD
  • Indacaterol
  • Lungs
  • Tuberculosis

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Health Policy
  • Public Health, Environmental and Occupational Health

Cite this

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; Yoon, Hyoung Kyu; Park, Myung Jae; Yoo, Kwang Ha; Jung, Ki Suck; Park, Jeong Woong; Lim, Seong Yong; Shim, Jae Jeong; Lee, Yong Chul; Kim, Young Sam; Oh, Yeon Mok; Kim, Song; Yoo, Chul Gyu.

In: International Journal of COPD, Vol. 12, 29.05.2017, p. 1589-1596.

Research output: Contribution to journalArticle

Kim, Cheong Ju ; Yoon, Hyoung Kyu ; Park, Myung Jae ; Yoo, Kwang Ha ; Jung, Ki Suck ; Park, Jeong Woong ; Lim, Seong Yong ; Shim, Jae Jeong ; Lee, Yong Chul ; Kim, Young Sam ; Oh, Yeon Mok ; Kim, Song ; Yoo, Chul Gyu. / 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. In: International Journal of COPD. 2017 ; Vol. 12. pp. 1589-1596.
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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 (treat-ment 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.",
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AU - Yoon, Hyoung Kyu

AU - Park, Myung Jae

AU - Yoo, Kwang Ha

AU - Jung, Ki Suck

AU - Park, Jeong Woong

AU - Lim, Seong Yong

AU - Shim, Jae Jeong

AU - Lee, Yong Chul

AU - Kim, Young Sam

AU - Oh, Yeon Mok

AU - Kim, Song

AU - Yoo, Chul Gyu

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N2 - 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 (treat-ment 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.

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 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 (treat-ment 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.

KW - Airflow limitation

KW - COPD

KW - Indacaterol

KW - Lungs

KW - Tuberculosis

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