PMID- 32982204 OWN - NLM STAT- MEDLINE DCOM- 20210623 LR - 20210623 IS - 1178-2005 (Electronic) IS - 1176-9106 (Print) IS - 1176-9106 (Linking) VI - 15 DP - 2020 TI - First-Line Treatment with Tiotropium/Olodaterol Improves Physical Activity in Patients with Treatment-Naive Chronic Obstructive Pulmonary Disease. PG - 2115-2126 LID - 10.2147/COPD.S268905 [doi] AB - BACKGROUND: Comparative effects on physical activity of mono and dual bronchodilators remain unclear in patients with treatment-naive chronic obstructive pulmonary disease (COPD). We sought to compare the changes in physical activity before and after tiotropium and tiotropium/olodaterol treatment in treatment-naive COPD patients. METHODS: A prospective, multicenter, randomized, open-labeled, and parallel interventional study was conducted. Eighty Japanese patients with treatment-naive COPD were randomized to receive either tiotropium or tiotropium/olodaterol treatment for 12 weeks. Spirometry and dyspnea index were assessed, and COPD assessment test (CAT) and the 6-minute walk distance (6MWD) were conducted before and after treatment. Evaluation of physical activity was assessed by a triaxle accelerometer over a 2-week period before and after treatment. RESULTS: There were no differences in the mean age (69.8 vs 70.4 years), body mass index (BMI) (22.5 vs 22.6 kg/m(2)) and mean % forced expiratory volume in 1 second (%FEV1) at baseline (61.5 vs 62.6%) between the two groups. Changes in FEV1 (mean+/-standard error, 242.8+/-28.8 mL) and transient dyspnea index (TDI) (2.4+/-0.3 points) before and after tiotropium/olodaterol treatment were greater than with tiotropium treatment (104.1+/-31.9 mL, p<0.01 and 1.5+/-0.3, p=0.02, respectively). Changes in the duration of physical activity with 1.0-1.5 metabolic equivalents (METs) estimated in the sedentary position following tiotropium/olodaterol treatment (-38.7+/-14.7 min) tended to be reduced more than with tiotropium treatment (-4.6+/-10.6 min) (p=0.06), although those with >/=2.0 METs numerically increased with both treatments (+10.8+/-7.6 min for tiotropium/olodaterol vs +8.3+/-7.6 min for tiotropium, p=0.82). Tiotropium/olodaterol treatment reduced the duration of physical activity with 1.0-1.5 METs (regression coefficient, -43.6 [95% CI -84.1, -3.1], p=0.04) in a multiple regression model adjusted for cofounding factors such as age, FEV1, total CAT scores, 6MWD, and TDI. CONCLUSION: This is the first study to report the impact of dual bronchodilator on physical activity in treatment-naive COPD patients of Japanese with low BMI. CI - (c) 2020 Takahashi et al. FAU - Takahashi, Koichiro AU - Takahashi K AUID- ORCID: 0000-0003-0461-5072 AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Uchida, Masaru AU - Uchida M AUID- ORCID: 0000-0002-2474-5619 AD - Division of Internal Medicine, Japan Community Health Care Organization Saga Central Hospital, Saga, Japan. FAU - Kato, Go AU - Kato G AD - Division of Respiratory Medicine, Saga Prefectural Medical Center Koseikan, Saga, Japan. FAU - Takamori, Ayako AU - Takamori A AD - Clinical Research Center, Saga University Hospital, Faculty of Medicine, Saga University, Saga, Japan. FAU - Kinoshita, Takashi AU - Kinoshita T AD - Division of Respirology, Neurology, and Rheumatology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan. FAU - Yoshida, Makoto AU - Yoshida M AD - Division of Respiratory Medicine, National Hospital Organization Fukuoka Hospital, Fukuoka, Japan. FAU - Tajiri, Ryo AU - Tajiri R AD - Clinical Research Center, Saga University Hospital, Faculty of Medicine, Saga University, Saga, Japan. FAU - Kojima, Keisuke AU - Kojima K AD - Division of Internal Medicine, Imari Arita Kyouritsu Hospital, Saga, Japan. FAU - Inoue, Hiroshi AU - Inoue H AD - Division of Internal Medicine, Karatsu Red Cross Hospital, Saga, Japan. FAU - Kobayashi, Hiromi AU - Kobayashi H AD - Division of Respiratory Medicine, National Hospital Organization East Saga Hospital, Saga, Japan. FAU - Sadamatsu, Hironori AU - Sadamatsu H AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Tashiro, Hiroki AU - Tashiro H AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Tanaka, Masahide AU - Tanaka M AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Hayashi, Shinichiro AU - Hayashi S AUID- ORCID: 0000-0003-4314-8526 AD - Division of Internal Medicine, Kouhoukai Takagi Hospital, Fukuoka, Japan. FAU - Kawaguchi, Atsushi AU - Kawaguchi A AD - Clinical Research Center, Saga University Hospital, Faculty of Medicine, Saga University, Saga, Japan. AD - Education and Research Center for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Kimura, Shinya AU - Kimura S AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Sueoka-Aragane, Naoko AU - Sueoka-Aragane N AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Kawayama, Tomotaka AU - Kawayama T AUID- ORCID: 0000-0002-9537-4229 AD - Division of Respirology, Neurology, and Rheumatology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan. CN - Saga-naive COPD Physical Activity Evaluation (SCOPE) Study Investigator Group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20200914 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 (Benzoxazines) RN - 0 (Bronchodilator Agents) RN - 0 (Drug Combinations) RN - VD2YSN1AFD (olodaterol) RN - XX112XZP0J (Tiotropium Bromide) SB - IM MH - *Adrenergic beta-2 Receptor Agonists/therapeutic use MH - Aged MH - *Benzoxazines/therapeutic use MH - Bronchodilator Agents/therapeutic use MH - Double-Blind Method MH - Drug Combinations MH - Exercise MH - Female MH - Forced Expiratory Volume MH - Humans MH - Lung MH - Male MH - Middle Aged MH - Prospective Studies MH - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug therapy MH - *Tiotropium Bromide/therapeutic use MH - Treatment Outcome PMC - PMC7501469 OTO - NOTNLM OT - chronic obstructive pulmonary disease OT - long-acting beta 2 agonist OT - long-acting muscarinic antagonist OT - physical activity COIS- This study was financially supported by Nippon Boehringer Ingelheim Co., Ltd. as an independent investigator study. Dr. Koichiro Takahashi received lecture fees from Nippon Boehringer Ingelheim and AstraZeneca. Dr. Takashi Kinoshita received grants from Daiichi Sankyo. Dr. Makoto Yoshida received lecture fees from AstraZeneca, GlaxoSmithKline and Novartis pharma. Dr. Tomotaka Kawayama received grants from Novartis Pharma, and lecture fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Novartis Pharma, Teijin Pharma and Home Healthcare, Sanofi, Kyorin Pharmaceutical, and Meiji Seika Pharma. Dr. Masaru Uchida, Dr. Go Kato, Dr. Ayako Takamori, Dr. Makoto Yoshida, Dr. Ryo Tajiri, Dr. Keisuke Kojima, Dr. Hiroshi Inoue, Dr. Hiromi Kobayashi, Dr. Hironori Sadamatsu, Dr. Hiroki Tashiro, Dr. Masahide Tanaka, Dr. Shinichiro Hayashi, Dr. Atsushi Kawaguchi, Dr. Shinya Kimura and Dr. Naoko Sueoka-Aragane did not have any conflicts of interests. EDAT- 2020/09/29 06:00 MHDA- 2021/06/24 06:00 PMCR- 2020/09/14 CRDT- 2020/09/28 05:37 PHST- 2020/06/26 00:00 [received] PHST- 2020/08/18 00:00 [accepted] PHST- 2020/09/28 05:37 [entrez] PHST- 2020/09/29 06:00 [pubmed] PHST- 2021/06/24 06:00 [medline] PHST- 2020/09/14 00:00 [pmc-release] AID - 268905 [pii] AID - 10.2147/COPD.S268905 [doi] PST - epublish SO - Int J Chron Obstruct Pulmon Dis. 2020 Sep 14;15:2115-2126. doi: 10.2147/COPD.S268905. eCollection 2020.