Late Breaking Abstract - Real-world evidence of dual bronchodilator therapy using Clinical COPD Questionnaire in 4700 COPD patients

Background: The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of COPD. Aim: This open-label, non-interventional study investigated changes in CCQ score during treatment with tiotropium/olodaterol (Tio/Olo) in clinical practice. Methods: Data were included from consenting COPD patients, enrolled in 11 countries, who were receiving a new prescription for Tio/Olo according to a treating physician. Patients were evaluated after receiving Tio/Olo for 6 weeks. The primary analysis was the proportion of patients achieving therapeutic success (0.4-point decrease in CCQ score between baseline and 6 weeks). Results: Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients; most were classified as GOLD B (51.7%) or D (42.8%). After 6 weeks’ treatment, 81.4% (95%CI 80.24–82.49) of patients achieved the predefined criteria of ‘therapeutic success’; mean improvement in overall CCQ score was 1.02 points. 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 in therapeutic success was seen in treatment-naive patients (85.7%), followed by those pretreated with LABA/ICS (79.5%) and LABA or LAMA monotherapy (74.2%). Rescue medication decreased by 1.25 puffs/day (95%CI 1.19–1.31) vs. baseline. In total, 29 patients (0.60%) reported drug-related adverse events (AEs) and 8 patients reported serious AEs (0.17%). Conclusions: In 4700 COPD patients, 6 weeks’ treatment with Tio/Olo improved CCQ and decreased use of rescue medication. The AE profile was consistent with the known safety profile of Tio/Olo.