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Yun Li &ast;, Junfeng Lin &ast;, Zihui Wang &ast;, Zhufeng Wang, Lunfang Tan, Shuyi Liu, Jinhai Huang, Yi Gao, Jinping Zheng National Clinical Research Center for Respiratory Disease, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Yi Gao; Jinping Zheng, National Clinical Research Center for Respiratory Disease, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Yuexiu District, Guangzhou, 510120, People’s Republic of China, Tel +86 20 83062869, Fax +86 20 83062729, Email misstall2@163.com; jpzhenggy@163.comBackground: In the 2021 ERS/ATS interpretive strategies for routine lung function tests, a positive bronchodilator response (BDR) was updated as a change of > 10% relative to the predicted value in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC). We aimed to explore the differences between the 2005 and 2021 ERS/ATS criteria applied to patients with asthma as well as chronic obstructive pulmonary disease (COPD).Methods: BDR test data about asthma patients aged 6– 80 years and COPD patients aged 18– 80 years were derived from the National Respiratory Medicine Center, First Affiliated Hospital of Guangzhou Medical University, from January 2017 to March 2022. BDR results defined by the 2005 and 2021 ERS/ATS criteria were named 2005-BDR and 2021-BDR, respectively. We compared differences between 2005-BDR and 2021-BDR and analyzed the trend in the proportion of positive BDR (BDR+) with the level of airflow obstruction.Results: A total of 4457 patients with asthma and 7764 patients with COPD were included in the analysis. The percentages of 2005-BDR+ and 2021-BDR+ were 63.32% and 52.84% for asthma, 30.92% and 22.94% for COPD, respectively. Of patients with 2005-BDR+, 81.86% for asthma and 70.18% for COPD showed 2021-BDR+ results, and these patients had higher FEV1%pred, FVC%pred (all P< 0.05). Whichever BDR criterion was adopted, the proportion of BDR+ had an upward linear trend with the increased degree of airflow obstruction in COPD, but exhibited an approximate inverted U-shaped curve in asthma. In COPD, the proportion of BDRFEV1 was negatively associated with the degree of airflow obstruction, while BDRFVC was positively associated (all P< 0.05).Conclusion: Compared with 2005-BDR+, the proportion of 2021-BDR+ reduced markedly in patients with asthma and COPD, but their trends with the degree of airflow obstruction did not change. Patients with consistent BDR+ had higher initial FEV1%pred and FVC%pred.Keywords: pulmonary function test, bronchodilator responsiveness testing, asthma, chronic obstructive pulmonary disease, European Respiratory Society, ERS, American Thoracic Society, ATS

Ming Hu,1,&ast; Pan Ding,1,&ast; Jinfang Ma,2 Nan Yang,1 Jinping Zheng,2 Naitong Zhou1 1West China School of Pharmacy Sichuan University, Chengdu, People’s Republic of China; 2State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Naitong Zhou, West China School of Pharmacy Sichuan University, No. 17, 3rd Section, Renmin South Road, Chengdu, 610041, People’s Republic of China, Tel +86-13881962880, Fax +86-28-85501387, Email zhou-2316@163.com Jinping Zheng, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou, 510120, People’s Republic of China, Tel +86 20 8306 2869, Fax +86 20 8306 2729, Email jpzhenggy@163.comIntroduction: Traditional Chinese medicine (TCM) is becoming increasingly important as it provides further options for treating many diseases worldwide. The TCM “Yupingfeng” has been used in China for over 800 years, and its clinical efficacy and safety for COPD treatment have been proven in previous studies. The objective of this study was to compare the long-term cost-effectiveness of Yupingfeng granules and the current conventional treatment for COPD patients in China.Methods: A Markov model was constructed from the perspective of the Chinese healthcare system using TreeAge Pro 2011. The model cycle length was 12 months, and the cycle time was set to 10 years. Data from a randomized controlled trial were used to generate the number of acute exacerbations, COPD assessment test (CAT) score and actual medication used. The state transition probabilities, costs and quality-adjusted life years (QALYs) were derived from available sources. A threshold of 72,447 yuan per QALY gained was used as a cost-effectiveness criterion. One-way and probabilistic sensitivity analyses were conducted to verify the model. In addition, the cost-effectiveness of a 35-year cycle was evaluated as a scenario analysis.Results: In the basic-case analysis, the ICER of adding Yupingfeng granules to the current conventional treatment drugs was ¥ 2123.04 per QALY, which was less than the threshold (one-time per capita GDP).Sensitivity analyses showed the results to be robust. Probabilistic sensitivity analysis showed that the probability of the ICER being less than the one-time per capita GDP threshold was 100%. In the scenario analysis, the incremental cost-effectiveness was ¥ 12,051.27 per QALY which was also under the one-time per capita GDP.Conclusion: By reducing the number of acute exacerbations of COPD, thereby correspondingly reducing the follow-up treatment cost, Yupingfeng granules combined with conventional treatment were found to provide a cost-effective therapeutic strategy for COPD.Keywords: Yupingfeng granule, traditional Chinese medicine, COPD, Markov model, cost-effectiveness analysis

Jin-Ping Zheng,1,* Jing Zhang,2,* Li-Jun Ma,3 Ping Chen,4 Mao Huang,5 Xue-Mei Ou,6 Zi-Wen Zhao,7 Shu-Juan Jiang,8 Jie Cao,9 Wanzhen Yao2 1State Key Laboratory of Respiratory Disease, National Clinical Research Center, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 2Department of Respiratory Medicine, Peking University Third Hospital, Beijing, People’s Republic of China; 3Department of Respiratory Medicine, Henan Provincial People’s Hospital, Henan, People’s Republic of China; 4Department of Internal Medicine, The Second Xiangya Hospital, Hunan, People’s Republic of China; 5Jiangsu Province Hospital, Jiangsu, People’s Republic of China; 6Department of Respiratory Medicine, West China Hospital, Chengdu, People’s Republic of China; 7Department of Respiratory Medicine, Guangzhou First People’s Hospital, Guangzhou, People’s Republic of China; 8Department of Respiratory Medicine, Shandong Provincial Hospital, Shandong, People’s Republic of China; 9Department of Respiratory Medicine, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China*These authors contributed equally to this workCorrespondence: Wanzhen YaoDepartment of Respiratory Medicine, Peking University Third Hospital, 49 North Garden Road, Beijing 100191, People’s Republic of ChinaTel +86 156 1190 8216Email yaowanzhen11@edusbm.comPurpose: The current guidelines recommend the use of systemic corticosteroids (SCS) as the optimal treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The aim of this real-world study was to evaluate whether nebulized budesonide (NBS) could also be used as an initial treatment for AECOPD.Patients and methods: AECOPD patients initially treated with NBS or SCS (oral/intravenous) were enrolled. A large-scale, long-term multicenter cohort study of AECOPD patients was performed to analyze outcomes for each treatment (NCT02051166).Results: Initial NBS and SCS treatment resulted in similar outcomes in terms of improvements in FEV1, PaO2, SaO2, and PaCO2. Disease severity affected outcome similarly in both groups. When the groups were stratified according to whether the initial treatment was subsequently intensified or reduced, more intubation was seen in the groups in which initial treatment was intensified. NBS escalation and SCS reduction groups spent more days in the hospital. The NBS escalation group was associated with the highest medical expenditure and a relatively higher rate of new-onset pneumonia. The NBS maintenance/reduction group showed the lowest mortality rate between groups. Stratification according to initial PaCO2 level showed more intubation in the groups with high initial PaCO2 concentrations.Conclusion: These results indicate that NBS may be used as an initial treatment in certain AECOPD patients, and further studies are needed to better define those most likely to benefit.Keywords: nebulized budesonide, systemic corticosteroids, chronic obstructive pulmonary disease, AECOPD &nbsp

Airway mucus hypersecretion is a frequent symptom associated with acute and chronic airway disease. Inhibition of mucus production or promotion of mucolysis not only relieved symptoms but also improved disease outcomes. There are numerous available mucoactive medicines for prescription, and how to select them properly for different diseases is important for clinical practice. So far, there is no one consensus or guideline reported. A group of Chinese pulmonary physicians worked together to complete this consensus based on literature review, summarized mechanism and usage of each classical mucoactive medicine. In general, antioxidant mucoactive medicines play an important role in chronic airway disease, including but not limited to airway mucus clearance, reduced acute exacerbation and improved pulmonary function.

Purpose Previous studies demonstrating efficacy and safety of once-daily umeclidinium (UMEC) in patients with chronic obstructive pulmonary disease (COPD) have included few Asian patients. This study evaluated efficacy and safety of UMEC 62.5 mcg versus placebo in Asian patients with COPD. Patients and Methods A Phase III, randomized, double-blind, parallel-group study. Patients (aged ≥40 years with COPD, pre-, and post-albuterol forced expiratory volume in 1 s [FEV1]/forced vital capacity ratio

Background It is unknown whether aggressive medication strategies should be used for early COPD with or without lung hyperinflation. We aimed to explore the characteristics and bronchodilator responsiveness of early COPD patients (stages I and II) with/without lung hyperinflation. Methods Four hundred and six patients with COPD who performed both lung volume and bronchodilation tests were retrospectively analyzed. Residual volume to total lung capacity >120% of predicted values indicated lung hyperinflation. The characteristics and bronchodilator responsiveness were compared between the patients with and without lung hyperinflation across all stages of COPD. Results The percentages of patients with lung hyperinflation were 72.7% in the entire cohort, 19.4% in stage I, 68.5% in stage II, 95.3% in stage III, and 100.0% in stage IV. The patients with lung hyperinflation exhibited poorer lung function but better bronchodilator responsiveness of both forced expiratory volume in 1 second and forced vital capacity than those without lung hyperinflation during early COPD (t=2.21–5.70, P=0.000–0.029), especially in stage I, while age, body mass index, smoking status, smoking history, and disease duration were similar between the two subgroups in the same stages. From stages I to IV of subgroups with lung hyperinflation, stage I patients had the best bronchodilator responsiveness. Use of bronchodilator responsiveness of forced vital capacity to detect the presence of lung hyperinflation in COPD patients showed relatively high sensitivities (69.5%–75.3%) and specificities (70.3%–75.7%). Conclusion We demonstrated the novel finding that early COPD patients with lung hyperinflation are associated with poorer lung function but better bronchodilator responsiveness and established a simple method for detecting lung hyperinflation.

Jinfang Ma,1 Jinping Zheng,1 Nanshan Zhong,1 Chunxue Bai,2 Haoyan Wang,3 Juan Du,4 Fenglei Li,5 Yanwei Chen,6 Zhe Shi,7 Xin Li,8 Pingyan Chen9 1State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 2Department of Respiratory Medicine, Zhongshan Hospital Affiliated to Fudan University, Shanghai, People’s Republic of China; 3Department of Respiratory Medicine, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, People’s Republic of China; 4Department of Respiratory Medicine, The Affiliated Hospital of Guizhou Medical University, Guiyang, People’s Republic of China; 5Department of Respiratory Medicine, The Liwan Hospital of the Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 6Department of Respiratory Medicine, Nanshan People’s Hospital, Shenzhen, People’s Republic of China; 7Department of Respiratory Medicine, The First People’s Hospital, Huizhou, People’s Republic of China; 8Department of Respiratory Medicine, China Resource and Wisco General Hospital, Wuhan, People’s Republic of China; 9Department of Biostatistics, Southern Medical University, Guangzhou, People’s Republic of China Purpose: Recurrence of acute exacerbations has a major impact on patients with COPD. Therefore, effective prevention and treatment of exacerbation is crucial in the management of COPD, especially for patients with moderate to severe disease. This study evaluated the effectiveness of YuPingFeng granule administration in preventing exacerbation and improving symptom score, as well as its long-term (1 year) safety profile, in patients with COPD. Patients and methods: This was a randomized, double-blind, parallel, placebo-controlled study of 240 patients from eight centers in China. Participants were eligible if they had mild to severe COPD as defined by Global Initiative for Chronic Obstructive Lung Disease, had a history of at least two COPD exacerbations or one hospitalization within the previous year, and had remained clinically stable for over 4weeks before the study. They were randomly assigned to receive 5g of YuPingFeng or placebo, three times per day, for 1year. The primary end point was the exacerbation rate over 1year, and the analysis was by intention to treat. Secondary end points included symptom score, which was assessed by COPD assessment test (CAT) score and safety profiles. This trial was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn; registration number: ChiCTR-IPR-15007023). Results: The YuPingFeng group had a significantly lower exacerbation rate than the placebo group (1.15 vs 1.55; risk ratio=0.677 [95% CI 0.531–0.863]; P=0.002) and a significantly reduced risk of second exacerbation (95% CI 0.326–0.772; P=0.002). After treatment, the mean change in the CAT score in the YuPingFeng group (-4.41±7.01) differed significantly from that in the placebo group (-2.49±5.31; P=0.001). YuPingFeng was well tolerated. Conclusion: YuPingFeng granules can be considered as a treatment option for COPD; this treatment prevents acute exacerbations of COPD and has a good safety profile. Keywords: COPD, exacerbation, treatment, YuPingFeng