Abstract

Introduction: No established guidelines exist for discontinuing inhaled corticosteroids (ICS) in stable COPD patients receiving triple therapy, and previous studies show conflicting results on the effects of ICS withdrawal. Aims and Objectives: This study aims to investigate the effects of ICS withdrawal in a real-world setting in Taiwan.  Methods: This multi-center, prospective, observational study (NCT04456205) recruited COPD patients who had been receiving triple therapy (a dual long-acting inhaled bronchodilator and ICS) for more than six months. Eligible patients were those with a CAT score less than 20, no acute exacerbation within six months, and an eosinophil count in blood less than 300 cells/?L. The primary objectives were to determine the effect of ICS withdrawal on lung function decline and the frequency of acute exacerbation after six months of discontinuation. The secondary objectives were to evaluate changes in clinical symptom assessments, including the COPD Assessment Test (CAT) score and the Modified Medical Research Council (mMRC) dyspnea scale. Results: After six months of follow-up, there was no significant difference observed in lung function change compared to baseline. The CAT score and mMRC scale did not show a significant difference either. During the follow-up period, only 5.4% of patients had documented acute exacerbation, and one patient died because of COPD. Conclusions: In stable COPD patients who have a blood eosinophil count less than 300 and have received triple therapy for more than six months, discontinuation of ICS did not lead to increased exacerbation rates, significant reduction of lung function, or worsening of symptoms.