Real World Study on the Reasons for eScalation or de-Escalation of Inhaled ThEraPies in COPD Patients: the STEPINCOPD Multicenter Observational Study.

Abstract

Background: There is limited data on the reasons for escalation or de-escalation of COPD inhaled therapies in routine clinical practice, especially after the follow-up pharmacological treatment guidance on the 2019 GOLD report and the 2020 ERS guideline on ICS withdrawal.

Methods: The STEPINCOPD study was a 12-week, two-visit, prospective observational study that aimed to describe the reasons for change of inhaled therapies, in accordance with GOLD recommendations 2021. Only patients that had a recent change in their inhaled medication were enrolled. Moreover, we investigated associations between physicians' and patients' characteristics and adherence to GOLD recommendations.

Results: 1429 patients were enrolled from 146 centers (138 private practice and 8 hospitals) throughout Greece. At enrollment, the most frequent reasons for treatment change were lack of clinical (78.9%) or spirometric (49.5%) response to previous treatment, change in CAT score (45.1%), and mMRC score (28.2%). At the follow-up visit, most common reasons were lack of clinical response to previous treatment (71.4%), COPD exacerbations (59.5%), changes in CAT score (52.4%), lack of spirometric response (42.9%) and lower respiratory tract infections (31%). We observed high adherence to the GOLD 2021 recommendations (81.6% at enrollment and 92.9% at follow-up). Physicians' age and consideration of GOLD recommendations for prescription choice, as well as patients' CAT score were significant predictors of adherence to GOLD.

Conclusion: The STEPINCOPD study highlights the reasons for inhaled treatment change in Greek physicians with high adherence to GOLD recommendations and provides insights for future research that may inform the development of decision support tools.