COPD Patients with a High Exacerbation Risk: Baseline Data Analysis of a National Chinese Prospective Multi-Center Study of Quality Improvement Project

Purpose: Patients with chronic obstructive pulmonary disease (COPD) with a history of frequent exacerbations have a high disease burden and poor progression, demanding optimized management. This study aimed to evaluate the real-world clinical situation, adherence to Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations, and the associated factors. Patients and Methods: We conducted a cross-sectional analysis of baseline data from the national multi-center Quality Improvement Program, which enrolled 1055 COPD patients with a high exacerbation risk from 40 hospitals across five geographic regions in China (NCT05638646). Patient characteristics, disease burden, management patterns and the associated factors were analyzed. Results: The study population had a mean age of 66.2 years, and 85.6% were male. Most patients had substantial disease burden, with 43.3% classified as GOLD stages 3– 4 and 93.6% categorized into GOLD group E. In previous 12 months, 39.0% and 67.2% of these patients experienced at least one moderate or severe exacerbation, respectively. Overall, 75.1% received maintenance therapy using long-acting bronchodilators, but only 17.7% were receiving maintenance therapy consistent with the GOLD recommendations for initial treatment. Among patients receiving inhaled therapy, 70.9% initiated maintenance therapy within one month after diagnosis, whereas the self-reported good compliance was only 47.3%. Despite most patients received inhalation technique checks and education, only 61.9% can use the inhalation device appropriately, as evaluated by research team. Hospital level, hospital region, availability of blood eosinophil counts, and disease severity were significantly associated with the management patterns. Conclusion: COPD patients with a high exacerbation risk in China had a substantial disease burden and important gaps between real-world management patterns and GOLD recommendations. These findings suggest opportunities to improve guideline implementation, particularly in secondary and county-based hospitals. Future studies should evaluate whether targeted quality improvement interventions can improve patient outcomes. Trial Registration Number: NCT05638646. Keywords: chronic obstructive pulmonary disease, disease burden, pharmacological treatment, non-pharmacological treatment, inhaled therapy management