Adjustments to maintenance therapy and the reasoning behind them among COPD outpatients in Austria: the STEP study.

Background: Adjustments to COPD maintenance treatment are based on different guidelines. In Austria, there is a lack of real-world data on treatment adjustments of COPD outpatients and their underlying rationale. The STEP study characterised change patterns of pharmacological maintenance therapy in COPD outpatients in predefined categories of step-up, step-down and switch, the underlying reasons, and predictors in clinical routine in Austria. Methods: STEP was a single-visit non-interventional study in Austria. 77 pulmonologists based in outpatient clinics documented previous and adapted COPD therapy, reason for change, patient characteristics, COPD phenotype, and lung function. Patients' COPD symptom burden was assessed by using the COPD Assessment Test (CAT). Predictors for therapy changes were identified. Results: 1137 patients were studied (mean±sd age 67±10 years; 56.9% male; mean forced expiratory volume in 1 s 56.3% predicted; Global Initiative for Chronic Obstructive Lung Disease B and E stages 66% and 19%, respectively; mean CAT score 17.5). Therapy step-up was observed in 59.3%, treatment switch in 21.7% and step-down in 19.0% of patients. Triple therapy comprised the biggest proportion of inhalation treatment (53.3%). Physicians reported lung function, symptom burden and exacerbations as the main reasons for step-up or step-down, whereas switches within the same treatment class were predominantly caused by device issues. Predictors for step-up were comorbid asthma and exacerbations among others. Conclusions: STEP was the first study to investigate COPD therapy changes in clinical routine in Austria. The most frequent treatment adjustment was step-up, followed by treatment switch and step-down. Symptom burden, stable or improved lung function and inhalation device handling were the most frequently given reasons for adjustments.