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Background: The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD)., Objective: This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice., Methods: Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks., Results: Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks' treatment, 81.4% (95% confidence interval [95% CI] 80.24-82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00-1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43-92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β 2 -agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19-1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%)., Conclusion: In 4700 COPD patients, 6 weeks' treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol., Competing Interests: Arschang Valipour has received speaker/consultancy fees from Boehringer Ingelheim during the conduct of the study; and speaker/consultancy fees from Boehringer Ingelheim, Chiesi, Novartis, Menarini and AstraZeneca outside the submitted work. Sergey Avdeev has nothing to disclose. Adam Barczyk has received personal fees from Boehringer Ingelheim. Valentina Bayer was an employee of Boehringer Ingelheim during the conduct of the study. Zvi Fridlender received institutional support for conducting the study from Boehringer Ingelheim. Dr Fridlender received personal fees for lectures/conference travel/advice from GlaxoSmithKline, Novartis, AstraZeneca, Boehringer Ingelheim, Teva and Rafa outside the submitted work. In addition, Dr. Fridlender has a patent for a neutrophil-specific drug delivery pending. Mariela Georgieva received trial sponsorship fees from Chiesi and AstraZeneca, grants for travel and lectures from Boehringer Ingelheim, grants for lectures from Mundipharma, and participated in lectures for Novartis outside the submitted work. Ondřej Kudela reports personal fees from the Charles University in Prague and Boehringer Ingelheim outside the submitted work. Alexey Medvedchikov was an employee of Boehringer Ingelheim during the conduct of the study. Ramona Miron has nothing to disclose. Maria Sanzharovskaya was an employee of Boehringer Ingelheim during the conduct of the study. Virginija Šileikienė has received advisory fees from AstraZeneca and GlaxoSmithKline, speaker fees from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, GlaxoSmithKline and Novartis, and has been involved with clinical trials for Boehringer Ingelheim, MSD and Novartis outside the submitted work. Jurij Šorli has nothing to disclose. Marc Spielmanns reports personal fees from Boehringer Ingelheim during the conduct of the study. Zsuzsanna Szalai has nothing to disclose. The authors report no other conflicts of interest in this work., (© 2021 Valipour et al.)