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Introduction: Symptom status and treatment changes among patients with chronic obstructive pulmonary disease (COPD) using inhaler treatment in real-world clinical settings are not well understood, particularly according to class of treatment. We investigated the proportion of symptomatic patients among those with COPD using inhaler treatment, based on COPD Assessment Test (CAT) scores in clinical practice, and changes in inhaler treatments and symptoms at 1-year follow-up. Methods: This was a retrospective analysis of data from a multicenter, prospective cohort study conducted at medical institutions with respiratory specialists in Japan. The primary endpoint was the proportion of patients with CAT scores ≥ 10 or < 10 in each inhaler treatment group at registration. Results: Of 414 patients in the full analysis set, 76 (18.4%), 261 (63.0%), and 77 (18.6%) were using long-acting muscarinic antagonist (LAMA), LAMA + long-acting β2-agonist (LABA), and inhaled corticosteroids (ICS) + LABA, respectively, at registration. The proportions of patients with CAT scores ≥ 10 or < 10 per inhaler treatment group at registration, respectively, were 32.9% and 67.1% in the LAMA group, 55.0% and 45.0% in the LAMA + LABA group, and 50.0% and 50.0% in the ICS + LABA group. Most patients (> 75%) in each inhaler treatment group showed no change in inhaler treatment at 1 year, regardless of their CAT score at registration. Approximately 70–80% of patients with CAT scores ≥ 10 at registration still had CAT scores ≥ 10 at 1 year; 10–30% of patients with CAT scores < 10 at registration had CAT scores ≥ 10 at 1 year. Conclusion: In real-world Japanese clinical practice, a considerable proportion of patients have persistent symptoms (CAT score ≥ 10) despite using mono or dual inhaler treatment; > 75% of symptomatic patients with COPD using inhaler treatment did not undergo treatment escalation at 1-year follow-up and remained symptomatic. Trial Registration: ClinicalTrials.gov identifier, NCT05903989. [ABSTRACT FROM AUTHOR]

Introduction: Real-world evidence is needed to optimize pharmacotherapy for chronic obstructive pulmonary disease (COPD). The effectiveness of inhaled tiotropium/olodaterol according to baseline symptoms and previous COPD treatment and predictors of response were assessed.Methods: This was a post hoc analysis of a 52-week post-marketing surveillance study of tiotropium/olodaterol in 1255 Japanese patients with COPD of all severities. We analyzed change in total COPD Assessment Test (CAT) score and lung function (forced expiratory volume in 1 s [FEV1] and forced vital capacity [FVC]). Patient subgroups were analyzed based on baseline CAT score (< 10 [n = 184], ≥ 10 [n = 507]) and previous COPD treatment (treatment-naive [n = 407], previously treated [n = 848], treatment with long-acting muscarinic antagonist monotherapy [n = 161]).Results: In the CAT ≥ 10 subgroup, tiotropium/olodaterol showed statistically significant improvements in mean total CAT score (- 6.2; 95% confidence interval [CI] - 7.2, - 5.1), FEV1 (0.109 L; 95% CI 0.059, 0.159) and FVC (0.171 L; 95% CI 0.096, 0.245), which continued through Week 52. CAT score and lung function improvement were greatest in treatment-naive patients: - 7.6 (95% CI - 9.2, - 6.1) mean total CAT score, 0.177 L (95% CI 0.076, 0.279) mean FEV1 and 0.178 L (95% CI 0.036, 0.319) mean FVC. Baseline factors associated with treatment response (total CAT score improvement ≥ 2 points) were: shorter COPD duration (odds ratio [OR] 0.91; 95% CI 0.87, 0.96), total CAT score ≥ 10 (OR 3.86; 95% CI 2.46, 6.06) and treatment-naive status (OR 1.86; 95% CI 1.12, 3.07). Baseline total CAT scores ≥ 13 predicted responses to tiotropium/olodaterol in all previous COPD treatment subgroups including treatment-naive patients.Conclusions: Tiotropium/olodaterol improved symptoms and lung function in Japanese COPD patients. Our results support the possible use of tiotropium/olodaterol in treatment-naive patients and those with total CAT scores ≥ 10.Trail Registration: Clinicaltrials.gov Identifier for parent study: NCT02850978. [ABSTRACT FROM AUTHOR]