Real-Life Effectiveness of Aclidinium/Formoterol on COPD Control: The REDACT Observational Study

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Abstract
Background: COPD control evaluates changes in patients’ status based on clinical impact and stability. There are limited data on the effectiveness of dual bronchodilation on COPD control. Methods: REDACT was a multicenter, prospective, single-arm, longitudinal real-life observational study that evaluated COPD control in uncontrolled COPD patients after 12 weeks of treatment with aclidinium/formoterol (Duaklir Genuair®). Eligible patients were previously receiving any inhaled medication except triple therapy (fixed or open combinations). The primary objective was to assess the proportion of patients who achieved COPD control after 12 weeks. Secondary aims included changes in COPD assessment test (CAT) and forced expiratory volume in 1 second (FEV1). Results: A total of 1038 patients with uncontrolled COPD, mean age 68.9 years, 69.6% male, were recruited and 1014 (97.7%) completed follow-up. The proportion of patients who achieved COPD control at 12 weeks was 83.7% (95% CI 81.3 to 86.0%). Low baseline FEV1 (% pred), history of moderate/severe exacerbation in the past year and history of cardiovascular disease were predictors of lack of control. Change from baseline in FEV1 was 124.8 mL (95% CI 108.7 to 141.0 mL, p< 0.001) and in CAT score − 7.6 points (95% CI − 7.9 to 7.3 points, p< 0.001). Proportions of patients that achieved the minimally clinically important difference of +100 mL in FEV1 and − 2 points in the CAT score were 50.4% and 90.5%, respectively. Conclusion: After 12 weeks of treatment with aclidinium/formoterol, a significant proportion of uncontrolled COPD patients achieved COPD control, with significant improvements in lung function and health status.

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