Exacerbation in Patients with Stable COPD in China: Analysis of a Prospective, 52-week, Nationwide, Observational Cohort Study (REAL)

Background: Chronic obstructive pulmonary disease (COPD) management in China is inadequate and there is a need to improve care and outcomes for patients nationwide.

Objectives: The REAL study was designed to generate reliable information on COPD management from a representative sample of Chinese patients with COPD. Here, we present study outcomes related to acute exacerbations.

Design: A 52-week, multicentre, prospective, observational study.

Methods: Outpatients (aged ⩾ 40 years) enrolled from 25 tertiary and 25 secondary hospitals across six geographic regions in China were followed for 12 months. Risk factors for COPD exacerbation and disease severity by exacerbation were assessed using multivariate Poisson and ordinal logistic regression models, respectively.

Results: Between June 2017 and January 2019, 5013 patients were enrolled, with 4978 included in the analysis. Mean (standard deviation) age was 66.2 (8.9) years. More patients presented with exacerbations in secondary tertiary hospitals (59.4% 40.2%) and in rural urban areas (53.2% 46.3%). Overall exacerbation rates differed across regions (range: 0.27-0.84). Patients from secondary tertiary hospitals had higher rates of overall exacerbation (0.66 0.47), severe exacerbation (0.44 0.18) and exacerbation that resulted in hospitalisation (0.41 0.16). Across regions and hospital tiers, the rates of overall exacerbation and exacerbations that resulted in hospitalisation were highest in patients with very severe COPD (based on the severity of airflow limitation or GOLD 2017 combined assessment). Strong predictors of exacerbation included demographic and clinical characteristics, modified Medical Research Council scores, mucus purulence, exacerbation history and the use of maintenance mucolytic treatment.

Conclusion: COPD exacerbation rates varied across regions and were higher in secondary compared with tertiary hospitals in China. Understanding the factors associated with COPD exacerbation may facilitate improved management of COPD exacerbations in China.

Registration: The trial was registered on 20 March 2017 (ClinicalTrials.gov: NCT03131362; https://clinicaltrials.gov/ct2/show/NCT03131362).

Plain Language Summary: Chronic obstructive pulmonary disease (COPD) causes progressive and irreversible airflow limitation. As the disease progresses, patients often experience a flare up of symptoms referred to as an exacerbation. There is inadequate management of COPD in China and, therefore, there is a need to improve care and outcomes for patients across the country. This study aimed to generate reliable information on exacerbations among Chinese patients with COPD to help inform future management strategies. Patients (aged ⩾ 40 years) were enrolled from 25 secondary and 25 tertiary hospitals across six regions of China. Physicians collected data over 1 year during routine outpatient visits. There were more patients who experienced an exacerbation in secondary tertiary hospitals (59% 40%) and in rural urban areas (53% 46%). Patients in different geographic regions experienced varying frequencies of exacerbations over 1 year. Compared with patients from tertiary hospitals, patients from secondary hospitals experienced exacerbations (including exacerbations that were severe and those that resulted in hospitalisation) at a higher frequency over 1 year. Patients with very severe disease experienced exacerbations (including exacerbations that resulted in hospitalisation) at the highest frequency over 1 year, regardless of the patient's geographic region or hospital tier. Patients who had certain characteristics and symptoms, had exacerbation(s) over the previous year, or received medication that aids in the clearance of mucus were more likely to experience exacerbations. The frequency of exacerbations among Chinese patients with COPD varied between patients living in different geographic regions and between patients presenting to different hospital tiers. Understanding the factors related to the occurrence of an exacerbation may help physicians better manage the disease.