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Maximilian Boesch,1 Florent Baty,1 Stefan Bilz,2 Martin H Brutsche,1 Frank Rassouli1 1Lung Center, Cantonal Hospital St.Gallen, St.Gallen, Switzerland; 2Division of Endocrinology & Diabetes, Cantonal Hospital St.Gallen, St.Gallen, SwitzerlandCorrespondence: Maximilian Boesch, Ph.D., Lung Center, Cantonal Hospital St. Gallen, Rorschacherstrasse 95, St. Gallen, CH-9007, Switzerland, Tel +41-71-494-7143, Email maximilian.boesch@kssg.chIntroduction: Lung function constraints and comorbidities such as coronary heart disease, sarcopenia, and mood disorders make chronic obstructive pulmonary disease (COPD) patients avoid physical activity (PA). However, PA represents an important pillar of COPD management and is explicitly recommended by professional associations to enhance physical functioning and positively modulate disease progression.Methods: In this monocentric, prospective, observational feasibility study, it was our primary objective to investigate the association between PA and the evolution of the COPD assessment test (CAT) and the occurrence of acute exacerbations of COPD (AECOPD), respectively. To this end, we equipped 42 COPD patients with an activity tracking wearable and telemonitored their daily PA levels over one year using a dedicated web-based interface. Patients additionally provided weekly CAT scores using the same telehealth platform and came in for 3 study visits to assess functional parameters and biochemical markers related to nutrition and inflammation.Results: A principal study finding was that PA was inversely associated with CAT score (drop of 0.21 points associated with an increase of 1000 daily steps, p = 0.004), and that the 50% of patients with higher PA levels showed less CAT score progression over time (0.42 points per year) than the 50% of patients with lower PA levels (3.26 points per year) (p < 0.001). In addition, higher PA levels were significantly associated with a lower likelihood of experiencing a moderate-to-severe AECOPD (31% risk reduction associated with an increase of 1000 daily steps, p = 0.0097).Discussion: Our study demonstrates the relevance of PA for key COPD outcome metrics in a real-world setting and underpins the importance of PA for COPD self-management in everyday life. Our study paves the way for future intervention trials to prospectively identify medically relevant PA thresholds and establish training recommendations for different patient subgroups.Keywords: CAT score, COPD, physical activity, telemonitoring, wearable device

Kai-Michael Beeh,1 Karl Scheithe,2 Heike Schmutzler,3 Saskia Krüger3 1Insaf Respiratory Research Institute, Wiesbaden, Germany; 2Department of Biostatistics, GKM Gesellschaft Für Therapieforschung mbH, Munich, Germany; 3Medical Department, BERLIN-CHEMIE AG, Berlin, GermanyCorrespondence: Kai-Michael Beeh, Insaf Respiratory Research Institute, Biebricher Allee 34, Wiesbaden, 65187, Germany, Tel +49 (0) 611 9854410, Email k.beeh@insaf-wi.dePurpose: Real-life effectiveness data on once-daily single-inhaler triple therapy (odSITT) with the inhaled corticosteroid fluticasone furoate (FF), the long-acting muscarinic antagonist umeclidinium (UMEC), and the long-acting β2-agonist vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) are important to complement evidence from well-controlled randomized clinical trials. Effectiveness of odSITT was quantified by assessing health status and symptoms in usual care.Patients and Methods: ELLITHE was a single-country (Germany), multicenter, open-label, non-interventional effectiveness study between 2020 and 2022, evaluating the effect of treatment initiation with FF/UMEC/VI 100/62.5/25 μg once-daily via the ELLIPTA inhaler on improvements in clinical outcomes versus baseline in COPD patients. The primary endpoint was the change in the total COPD Assessment Test (CAT) score between baseline and month 12. Key secondary endpoints included change in CAT score over time, occurrence of exacerbations until month 12, changes in forced expiratory volume in one second (FEV1), inhaler adherence, and safety.Results: Nine hundred and six patients were included (age 66.6 years, 55.6% male, mean FEV1 52.6% of predicted, mean CAT 21.5 units, 1.4 exacerbations/year pre-study). About 63.9% of patients were escalated from dual therapies, and 18% were switched from multiple-inhaler triple therapies. Reductions in CAT score at month 12 were statistically significant and above the threshold of clinical importance (− 2.6 units; p < 0.0001). CAT score also improved at interim visits. CAT improvements were more pronounced in patients with high baseline scores and better inhaler adherence. Exacerbations during follow-up were rare (0.2 events/year) compared to pre-study (1.4 events/year). FEV1 was improved by 93 mL (p < 0.0001). No new safety effects were observed.Conclusion: In usual care, treatment with odSITT resulted in significant and clinically relevant improvements of CAT score and FEV1 in COPD patients, regardless of the occurrence of exacerbations. These findings challenge the current guideline recommendations for SITT only in patients experiencing exacerbations.Keywords: CAT score, real-world evidence, lung function, exacerbation, treatment adherence

Christian Gessner,1 Frederik Trinkmann,2,3 Sanaz Bahari Javan,4 Raimund Hövelmann,4 Valentina Bogoevska,4 George Georges,5 Elena Nudo,6 Carl-Peter Criée7 1Pneumologische Praxis Leipzig, Universitätsklinikum Leipzig, Institut für Klinische Immunologie, Leipzig, Germany; 2Pneumology and Critical Care Medicine, Thoraxklinik at University Hospital Heidelberg, Translational Lung Research Center Heidelberg (TLRC), Member of German Center for Lung Research (DZL), Heidelberg, Germany; 3Department of Biomedical Informatics (DBMI) at the Center for Preventive Medicine and Digital Health Baden-Württemberg (CPD-BW), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany; 4Department of Medical Affairs, Chiesi GmbH, Hamburg, Germany; 5Corporate R&D, Chiesi USA Inc., Cary, NC, USA; 6Global Medical Affairs, Chiesi Farmaceutici S.p.A., Parma, Italy; 7Department of Sleep and Respiratory Medicine, Evangelical Hospital Goettingen-Weende, Bovenden, GermanyCorrespondence: Christian Gessner, Pneumologische Praxis Leipzig, Universitätsklinikum Leipzig, Institut für Klinische Immunologie, Tauchaer Straße 12, Leipzig, 04357, Germany, Tel +49 341 60 20 960, Email ch.gessner@pneumologe-leipzig.dePurpose: Real-word evidence on the effectiveness of switching from dual therapies or triple therapies (multiple inhalers) to extrafine single-inhaler triple therapy (efSITT), which consists of the inhaled corticosteroid (ICS) beclomethasone, the long-acting β2-agonist (LABA) formoterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) is limited. The impact of switching to efSITT on health-related quality of life (HRQoL), COPD specific symptoms, lung function and treatment adherence were assessed in routine clinical care.Patients and Methods: Patients were recruited at 148 sites in Germany between 2017 and 2020 in this multicenter, non-interventional observational study. Demographics, clinical data and treatment history were collected at baseline. HRQoL (measured by COPD Assessment Test [CAT]), lung function and adherence (measured by Test of Adherence to Inhalers [TAI]) were assessed at baseline and after six months. Descriptive analyses were conducted by prior treatment and GOLD groups as well as for the overall population.Results: 55.1% of the 2623 included patients were male. Mean age was 65.8 years. 57.5% of the patients were previously treated with ICS+LABA+LAMA (multiple inhalers), 23.9% with ICS/LABA (single or two inhalers) and 18.6% with LAMA/LABA (single or two inhalers). After six months, largest mean improvements in the total CAT score were observed in the ICS/LABA (− 3.9) and LAMA/LABA (− 3.9) prior treatment groups as well as in patients in GOLD group B (− 2.9). In the overall population, the CAT items for cough, phlegm, and dyspnea decreased on average by − 0.4 points each. After six months, FEV1 increased by 2.0 percentage points in relation to predicted values. The percentages of measured sRtot and RV of predicted values decreased by 24.5 and 4.4 percentage points, respectively. The percentage of patients with good adherence increased from 67.8% to 76.5%.Conclusion: Treatment switch to efSITT resulted in an improvement of HRQoL, COPD specific symptoms, lung function parameters and adherence under real-world conditions.Keywords: COPD, extrafine single inhaler triple therapy, treatment adherence, CAT score

Arto Yuwono Soeroto,1 Dadan Setiawan,2 Nabila Nauli Asriputri,3 Guntur Darmawan,4 Geraldo Laurus,3 Prayudi Santoso1 1Division of Respiratory and Critical Illness, Department of Internal Medicine, Faculty of Medicine Universitas Padjadjaran, Hasan Sadikin General Hospital, Bandung, Indonesia; 2Department of Internal Medicine, Occupational Health General Hospital, Bandung, West Java, Indonesia; 3Department of Internal Medicine, Faculty of Medicine Universitas Padjadjaran, Hasan Sadikin General Hospital, Bandung, Indonesia; 4Department of Internal Medicine, Faculty of Medicine, Krida Wacana Christian University, Jakarta, IndonesiaCorrespondence: Arto Yuwono Soeroto Tel +62 811 246 930Email aysoeroto@yahoo.co.idPurpose: This study aimed to assess the association between vitamin D levels and forced expiratory volume in one second (FEV1), number of exacerbations, and symptoms based on COPD assessment test (CAT) scores in stable COPD patients in Indonesia.Patients and Methods: An observational cross-sectional study was conducted. Subjects were stable COPD patients who were treated at a pulmonary clinic in a tertiary referral hospital in West Java from March to June 2018.Results: Thirty subjects were recruited this study with an average age 62± 8 years. The mean vitamin D level was 20.17± 8.91 ng/mL. Half of the patients had low vitamin D level (< 20ng/mL) (50%). The mean FEV1 (%) predicted value was 37.2± 14. The median exacerbation per year was 1 (0– 5) and symptoms based on CAT score was 14 (3– 34). No correlation was found between vitamin D levels and FEV1 (%) predicted value (r=0.126, p=0.253). Vitamin D level was inversely correlated with number of exacerbations (r=− 0.639, p< 0.001) and CAT (r= − 0.802, p< 0.001).Conclusion: Low level of vitamin D was associated with more frequent exacerbation and higher CAT scores but was not associated with FEV1 (%) predicted.Keywords: COPD, vitamin D, FEV1, CAT score

Joon Young Choi,1 Hyoung Kyu Yoon,2 Kyeong-Cheol Shin,3 So-Young Park,4 Chang Youl Lee,5 Seung Won Ra,6 Ki Suck Jung,7 Kwang Ha Yoo,4 Chang-Hoon Lee,8 Chin Kook Rhee9 1Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, St. Vincent’s Hospital, The Catholic University of Korea, Suwon, Republic of Korea; 2Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yeouido St Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; 3Division of Pulmonology and Allergy, Regional Center for Respiratory Disease, Yeungnam University Medical Center, Daegu, Republic of Korea; 4Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea; 5Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical Center, Chuncheon, Republic of Korea; 6Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea; 7Division of Pulmonary Medicine, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, Anyang, Republic of Korea; 8Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; 9Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaCorrespondence: Chin Kook RheeDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpodaero, Seochogu, Seoul 06591, Republic of KoreaTel +82 2 2258 6067Fax +82 2 599 3589Email chinkook77@gmail.comPurpose: Previous studies have used various definitions to classify chronic obstructive pulmonary disease (COPD) patients into chronic bronchitis (CB) and non-CB patients. This study was performed to identify differences among three definitions of CB based on the classical method, St. George’s Respiratory Questionnaire (SGRQ), and the CAT (COPD Assessment Test) score.Patients and methods: We extracted data from the multicenter Korea COPD Subgroup Study (KOCOSS) cohort, for which patients recruited from among 47 medical centers in South Korea beginning in April 2012. Patients were classified according to three different definitions of CB: 1) classical definition; 2) SGRQ (using questions regarding cough and sputum); and 3) CAT score (comprising cough [CAT1] and sputum [CAT2] subscale scores).Results: A total of 2694 patients were enrolled in this study. The proportions of CB were 10.8%, 35.8%, and 24.0% according to the classical, SGRQ, and CAT definitions, respectively. The three definitions yielded consistently significant differences between CB and non-CB patients in modified Medical Research Council dyspnea scale CAT score, SGRQ score, number of moderate-to-severe exacerbations per year and forced expiratory volume in 1 second. By three definitions, CB consistently predicted future risk of exacerbation. The kappa coefficient of agreement between the classical definition and SGRQ definition was 0.29, that of the classical definition and CAT definition was 0.32, and that of the SGRQ definition and CAT definition was 0.44.Conclusion: Patients with CB according to the new definitions based on SGRQ or CAT score showed similar clinical characteristics to those defined according to the classical definition. The new CB definitions may be used as alternatives to the classical definition.Keywords: chronic bronchitis, CAT score, SGRQ score, chronic obstructive pulmonary disease, KOCOSS database

Peng-Fei Liu,1 Peng Yan,1 Da-Hui Zhao,1 Wen-Fang Shi,1 Song Meng,1 Yang Liu,2 Bin Liu,2 Guo-Feng Li,2 Li-Xin Xie1 1Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital, Beijing, 2Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Logistic University of Chinese People’s Armed Police Force, Tianjin, People’s Republic of China Objective: The objective of the study was to analyze the effect of environmental factors on the differential expression of microRNAs in the peripheral blood of migratory and local patients in northern People’s Republic of China and on clinical symptoms of local patients in northern People’s Republic of China with COPD. Methods: A total of 118 patients in the northern region and 8 migratory patients were enrolled in this prospective study. We collected general information. Blood samples were collected from 9 patients in the Beijing group, from 8 patients in the migratory group and from 9 healthy control subjects. After extracting the total RNA from these 3 groups, serum miRNA was identified by Solexa sequencing. We collected COPD assessment test (CAT) and Modified British Medical Research Council (mMRC) scores at different levels of air pollution and also collected the number of exacerbations over the year prior to the baseline and in the year preceding the follow-up. Results: In total 9 miRNAs were differentially expressed. When air quality index (AQI) >100, the CAT and mMRC scores at baseline were significantly higher than those when the AQI ≤100 (P100, the follow-up CAT and mMRC scores were significantly higher than those when AQI ≤100 (P100, the baseline CAT score of this fewer symptoms group was 10.00 (6.25–12.00). The median CAT score was close to 10. When AQI ≤100, the follow-up CAT score of the fewer symptoms group was 8.00 (4.25–12.00). However, when AQI >100, the follow-up CAT score of the fewer symptoms group was 9.50 (6.00–16.75). The median CAT score was close to 10. Conclusion: Environmental factors may cause differential expression of miRNAs in the peripheral blood of migratory and local patients in northern People’s Republic of China. Air pollution may aggravate clinical symptoms of patients with COPD. Keywords: COPD, miRNA, environment, CAT score, mMRC

Background: Data suggesting that low physical activity levels are associated with increased mortality and exacerbations in patients with COPD have led to increasing interest in the role of physical activity in COPD. This study evaluated self-reported functional performance, a measure of physical activity impairment, according to current treatment regimen, lung function, symptoms, and Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 groups in a large sample of patients with COPD., Methods: This multicenter, cross-sectional, observational study (study identifier: D5970R00003) included patients with COPD (≥40 years) in the USA. A self-completion questionnaire captured demographics and patient-reported outcomes, including the Functional Performance Inventory-Short Form (FPI-SF). Diagnosis and treatment history (including spirometry results) were extracted from medical charts. Multiple linear regression was used to determine the relationship between FPI-SF and FEV 1 % predicted, and FPI-SF and COPD assessment test (CAT) score., Results: Overall, 1,775 patients participated (classified as GOLD 2017 group A, 14.8%; B, 46.6%; C, 2.6%; D, 36.0%). Physical activity impairment affected patients across all treatment regimens and GOLD groups (mean FPI-SF total score: 2.1), with the greatest impairment within FPI-SF observed for domains requiring most physical exertion, "physical exercise" and "maintaining the household" (mean FPI-SF scores: 1.7 and 1.8, respectively). Patients receiving loose triple therapy and those in GOLD group D had the highest impairment (mean FPI-SF total scores: both 1.9), and the lowest FEV 1 % predicted (55.5% and 54.7%, respectively). FPI-SF total score correlated with FEV 1 % predicted and more strongly with CAT score (all P <0.05)., Conclusion: The stronger correlation between FPI-SF and CAT scores compared to FPI-SF and FEV 1 % predicted suggests that symptoms may have a greater impact on patients' functional performance than lung function. Further longitudinal studies are required to establish a correlation between the effect of treatment on symptoms, lung function, and physical activity., Competing Interests: Disclosure BD and SS are employees of AstraZeneca. DJ, MS, and NB-E are employees of Adelphi Real World. This work was supported by AstraZeneca. The funder of the study was involved in study design, data analysis, data interpretation, and writing of the report. All authors had full access to all the data in the study and the corresponding author had the final responsibility for the decision to submit for publication. No restrictions were placed on authors regarding the statements made in the manuscript. The authors report no other conflicts of interest in this work.