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 β2-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.

1 M Sechenov 1st Moscow State Medical University Moscow Russia

Boehringer Ingelheim Pharmaceuticals Inc Ridgefield CT USA

Boehringer Ingelheim RCV GmbH and Co KG Vienna Austria

Bolnišnica Topolšica Topolšica Slovenia

Clinical Pneumophtysiology Hospital Iasi Iasi Romania

Department of Pneumology Faculty of Medicine in Hradec Kralove University Hospital Hradec Kralove Charles University Prague Hradec Kralove Czech Republic

Department of Respiratory and Critical Care Medicine Karl Landsteiner Institute for Lung Research and Pulmonary Oncology Vienna Health Care Group Klinik Floridsdorf Vienna Austria

Faculty of Medicine Clinic of Chest Diseases Immunology and Allergology Institute of Clinical Medicine Vilnius University Vilnius Lithuania

Hadassah Hebrew University Medical Center Jerusalem Israel

Medical Center Sv ivan Rilski OOD Vidin Bulgaria

Petz Aladar County Teaching Hospital Gyor Hungary

Wydział Nauk Medycznych Śląskiego Uniwersytetu Medycznego Katowice Poland

Zürcher RehaZentrum Wald Wald Switzerland

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