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Nijra L Lugogo,1 Enrico Heffler,2,3 Vicente Plaza,4 Ole Hilberg,5 Changming Xia,6 Scott Nash,6 Nami Pandit,7 Juby A Jacob-Nara,7 Harry J Sacks,6 Paul J Rowe,7 Yamo Deniz,6 Megan Hardin,8 Xavier Soler6 1University of Michigan Medical School, Ann Arbor, MI, USA; 2IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; 3Humanitas University, Pieve Emanuele, Milan, Italy; 4Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 5Lillebaelt Hospital, Vejle, Denmark; 6Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA; 7Sanofi, Bridgewater, NJ, USA; 8Sanofi, Cambridge, MA, USACorrespondence: Nijra L Lugogo, University of Michigan Medical School, 300 North Ingalls St, Suite 2C40, Ann Arbor, MI, 48109, USA, Email nlugogo@med.umich.edu

Kristina Kock Hansen,1,2 Ole Hilberg,1,2 Hanne Irene Jensen,2,3 Anders Løkke,1,2 Ingeborg Farver-Vestergaard2,4 1Department of Respiratory Diseases, Lillebaelt Hospital, Vejle, University Hospital of Southern Denmark, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Department of Anaesthesiology and Intensive Care, Lillebaelt Hospital, Vejle, University Hospital of Southern Denmark, Denmark; 4Department of Medicine, Lillebaelt Hospital, Vejle, University Hospital of Southern Denmark, DenmarkCorrespondence: Kristina Kock Hansen, Department of Respiratory Diseases, Lillebaelt Hospital, Vejle, University Hospital of Southern Denmark, Beriderbakken 4, Vejle, 7100, Denmark, Tel +45 20189828, Email kristina.kock.hansen2@rsyd.dkPurpose: Patients with COPD experience anxiety, depression, and stress more frequently than in the age and gender-matched general population. This cross-sectional study aimed to examine the relationship between cognitive functions and the psychological factors of anxiety, depression and stress among patients with COPD.Patients and Methods: Between January 2021 and January 2023, patients with severe COPD were recruited, along with age-matched controls. Participants completed the Hospital Anxiety and Depression Scale (HADS) and the Perceived Stress Scale (PSS). The Montreal Cognitive Assessment (MoCA), a continuous reaction time test (CRT), and a driving simulator were used to assess cognitive impairment. Hierarchical multiple linear regression analyses were used to explain the variance of the correlations.Results: In total, 80 patients (mean age = 64yrs) and 22 controls (mean age = 61yrs) participated in the study. Patients reported significantly higher levels of psychological symptoms compared to the controls (p ≤ 0.001). We found no differences in anxiety (p = 0.31), depression (p = 0.66) and stress (p = 0.37) between patients with and without cognitive impairment. However, stress showed to be a significant predictor of decreased attention (higher stress score resulted in decreasing CRT-index, indication a reduced stability in reaction time) (p = 0.02). Psychological factors did not explain additional variance in cognitive functions beyond sociodemographic factors such as age and sex.Conclusion: Psychological symptom levels are higher in COPD than controls and perceived stress among patients with COPD appears to be associated with decreased attention. However, psychological factors in general did not appear to contribute to the variance in cognitive functions beyond sociodemographic, physical, and self-perceived symptoms.Keywords: chronic obstructive pulmonary disease, cognitive impairment, Montreal Cognitive Assessment, anxiety, depression, stress

Anders Løkke,1,2 Ole Hilberg,1,2 Peter Lange,3,4 Rikke Ibsen,5 Gunilla Telg,6 Georgios Stratelis,6 Jesper Lykkegaard7 1Department of Medicine, Little Belt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Medical Department, Copenhagen University Hospital-Herlev, Herlev, Denmark; 4Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; 5i2Minds, Aarhus, Denmark; 6AstraZeneca Nordic, Södertälje, Sweden; 7Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, Odense, DenmarkCorrespondence: Anders Løkke, Department of Medicine, Little Belt Hospital, Vejle, Denmark, Email Anders.Lokke@rsyd.dkObjective: Patients with chronic obstructive pulmonary disease (COPD) commonly present with cardiovascular disease (CVD). We investigated the association between COPD exacerbations and major cardiovascular (CV) events in a COPD population with a history of CVD.Methods: This population-based and register-based cohort study identified all Danish COPD patients aged ≥ 40 years who visited a hospital-based, pulmonary outpatient clinic for COPD between 1st January, 2010, and 31st December, 2016, from a nationwide COPD registry. Patients with a history of a major CV event 36‒6 months prior to their COPD measurement date and no CV event 6 months before this date were included. During a 6-month assessment period, the risks of a new CV event (hospitalization with fatal/non-fatal stroke, myocardial infarction, or heart failure) and moderate and severe COPD exacerbations were evaluated. Odds ratios with 95% confidence intervals for CV events and death were estimated using adjusted logistic regression models.Results: Of the 1501 COPD patients included, 55% experienced a COPD exacerbation and 13% experienced both an exacerbation and a CV event during follow-up (6 months). The odds of a CV event were 1.5 times higher in patients with a moderate exacerbation and more than 6-times higher in those with a severe exacerbation vs patients with no exacerbation(s). The majority of CV events occurred within 30 days post exacerbation in patients who experienced both an exacerbation and a CV event. In total, 113 patients died during the study period: 28% of deaths were caused by CVD and 72% by reasons other than CVD, mostly COPD.Conclusion: In patients with known CVD, severe COPD exacerbations are associated with increased odds of major CV events that occur within 30 days post exacerbation, highlighting the need to prevent exacerbations in COPD patients with concomitant CVD to potentially improve both respiratory and CV health.Keywords: concomitant cardiovascular disease, respiratory health, cardiovascular health, prevention, real-world evidence

Wenjia Chen,1 Mohsen Sadatsafavi,2 Trung N Tran,3 Ruth B Murray,4 Chong Boon Nigel Wong,1 Nasloon Ali,4,5 Cono Ariti,4,5 Esther Garcia Gil,6 Anthony Newell,5,7 Marianna Alacqua,8 Mona Al-Ahmad,9 Alan Altraja,10 Riyad Al-Lehebi,11,12 Mohit Bhutani,13 Leif Bjermer,14 Anne Sofie Bjerrum,15 Arnaud Bourdin,16 Lakmini Bulathsinhala,4,5 Anna von Bülow,17 John Busby,18 Giorgio Walter Canonica,19,20 Victoria Carter,4,5 George C Christoff,21 Borja G Cosio,22 Richard W Costello,23 J Mark FitzGerald,24 João A Fonseca,25 Kwang Ha Yoo,26 Liam G Heaney,27 Enrico Heffler,19,20 Mark Hew,28,29 Ole Hilberg,30 Flavia Hoyte,31,32 Takashi Iwanaga,33 David J Jackson,34,35 Rupert C Jones,36 Mariko Siyue Koh,37,38 Piotr Kuna,39 Désirée Larenas-Linnemann,40 Sverre Lehmann,41 Lauri A Lehtimäki,42,43 Juntao Lyu,5,7 Bassam Mahboub,44,45 Jorge Maspero,46,47 Andrew N Menzies-Gow,48 Concetta Sirena,49 Nikolaos Papadopoulos,50,51 Andriana I Papaioannou,52 Luis Pérez de Llano,53,54 Diahn-Warng Perng,55,56 Matthew Peters,57 Paul E Pfeffer,58,59 Celeste M Porsbjerg,17 Todor A Popov,60 Chin Kook Rhee,61 Sundeep Salvi,62 Camille Taillé,63 Christian Taube,64 Carlos A Torres-Duque,65 Charlotte S Ulrik,66 Seung Won Ra,67 Eileen Wang,31,32 Michael E Wechsler,68 David B Price4,5,69 1Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore; 2Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada; 3AstraZeneca, Gaithersburg, MD, USA; 4Optimum Patient Care, Cambridge, UK; 5Observational and Pragmatic Research Institute, Singapore, Singapore; 6AstraZeneca, Barcelona, Spain; 7Optimum Patient Care, Queensland, VIC, Australia; 8AstraZeneca, Cambridge, UK; 9Microbiology Department, Faculty of Medicine, Kuwait University, Al-Rashed Allergy Center, Ministry of Health, Kuwait City, Kuwait; 10Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia; 11Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia; 12College of Medicine, Alfaisal University, Riyadh, Saudi Arabia; 13Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Western Canada, AB, Canada; 14Department of Clinical Sciences, Respiratory Medicine and Allergology, Skåne University Hospital, Lund University, Lund, Sweden; 15Department of Respiratory Medicine and Allergy, Aarhus University Hospital, Jutland, Aarhus, Denmark; 16PhyMedExp, Univ Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France; 17Respiratory Research Unit, Bispebjerg University Hospital, Copenhagen, Denmark; 18Centre for Public Health, Queen’s University Belfast, Belfast, Northern Ireland; 19Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Milan, Italy; 20Department of Biomedical Sciences, Humanitas University, Milan, Italy; 21Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria; 22Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain; 23Department of Respiratory Medicine, Clinical Research Centre, Smurfit Building Beaumont Hospital, RCSI, Dublin, Ireland; 24Department of Medicine, the University of British Columbia, Vancouver, BC, Canada; 25Comunity Health, Information and Decision Sciences Department (MEDCIDS) & Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine of University of Porto, Porto, Portugal; 26KonKuk University School of Medicine in Seoul, Seoul, Korea; 27Wellcome-Wolfson Centre for Experimental Medicine, Queen’s University Belfast, Belfast, Northern Ireland; 28Allergy, Asthma & Clinical Immunology Service, Alfred Health, Melbourne, VIC, Australia; 29Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; 30Medical Department, Vejle University Hospital, Jutland, Vejle, Denmark; 31Department of Medicine, Division of Allergy and Clinical Immunology, National Jewish Health, Denver, CO, USA; 32Department of Internal Medicine, Division of Allergy & Clinical Immunology, University of Colorado School of Medicine, Aurora, CO, USA; 33Center for General Medical Education and Clinical Training, Kindai University Hospital, Osakasayama, Japan; 34UK Severe Asthma Network and National Registry, Guy’s and St Thomas’ NHS Trust, London, UK; 35School of Immunology & Microbial Sciences, King’s College London, London, UK; 36Research and Knowledge Exchange, Plymouth Marjon University, Plymouth, UK; 37Respiratory & Critical Care Medicine, Singapore General Hospital, Singapore, Singapore; 38SingHealth Duke-NUS Lung Centre, Singapore, Singapore; 39Division of Internal Medicine, Asthma and Allergy Medical University of &Lstrok;ód&zacute;, &Lstrok;ód&zacute;, Poland; 40Directora Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Ciudad de México, Mexico; 41Section of Thoracic Medicine, Department of Clinical Science, University of Bergen, Bergen, Norway; 42Allergy Centre, Tampere University Hospital, Tampere, Finland; 43Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; 44College of Medicine, University of Sharjah, Sharjah, United Arab Emirates; 45Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates; 46Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; 47University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina; 48Royal Brompton & Harefield Hospitals, London, UK; 49Severe Asthma Network in Italy (SANI), Milano, Italy; 50Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, UK; 51Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece; 52 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece; 53Pneumology Service, Lucus Augusti University Hospital, EOXI Lugo, Lugo, Spain; 54Biodiscovery Research Group, Health Research Institute of Santiago de Compostela, Santiago de Compostela, Spain; 55Division of Clinical Respiratory Physiology Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan; 56COPD Assembly of the Asian Pacific Society of Respirology Hongo, Bunkyo-ku, Tokyo, Japan; 57Department of Thoracic Medicine, Concord Hospital, Sydney, NSW, Australia; 58Department of Respiratory Medicine, Barts Health NHS Trust, London, UK; 59Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK; 60University Hospital ”sv. Ivan Rilski”, Sofia, Bulgaria; 61Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Seoul St. Mary’s Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea; 62Pulmocare Research and Education Foundation, Pune, India; 63Department of Respiratory Diseases, Bichat Hospital, AP-HP Nord-Université de Paris, Paris, France; 64Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany; 65CINEUMO, Respiratory Research Center, Fundación Neumológica Colombiana, Bogotá, Colombia; 66Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark; 67Department of Internal Medicine, Division of Pulmonology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea; 68Department of Medicine, NJH Cohen Family Asthma Institute, National Jewish Health, Denver, CO, USA; 69Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: David B Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, &num;06 Midview City, Singapore, Singapore, 573969, Tel +65 3105 1489, Email dprice@opri.sgBackground: Many severe asthma patients with high oral corticosteroid exposure (HOCS) often do not initiate biologics despite being eligible. This study aimed to compare the characteristics of severe asthma patients with HOCS who did and did not initiate biologics.Methods: Baseline characteristics of patients with HOCS (long-term maintenance OCS therapy for at least 1 year, or ≥ 4 courses of steroid bursts in a year) from the International Severe Asthma Registry (ISAR; https://isaregistries.org/), who initiated or did not initiate biologics (anti-lgE, anti-IL5/5R or anti-IL4R), were described at the time of biologic initiation or registry enrolment. Statistical relationships were tested using Pearson’s chi-squared tests for categorical variables, and t-tests for continuous variables, adjusting for potential errors in multiple comparisons.Results: Between January 2015 and February 2021, we identified 1412 adult patients with severe asthma from 19 countries that met our inclusion criteria of HOCS, of whom 996 (70.5%) initiated a biologic and 416 (29.5%) did not. The frequency of biologic initiation varied across geographical regions. Those who initiated a biologic were more likely to have higher blood eosinophil count (483 vs 399 cells/μL, p=0.003), serious infections (49.0% vs 13.3%, p< 0.001), nasal polyps (35.2% vs 23.6%, p< 0.001), airflow limitation (56.8% vs 51.8%, p=0.013), and uncontrolled asthma (80.8% vs 73.2%, p=0.004) despite greater conventional treatment adherence than those who did not start a biologic. Both groups had similar annual asthma exacerbation rates in the previous 12 months (5.7 vs 5.3, p=0.147).Conclusion: Around one third of severe HOCS asthma patients did not receive biologics despite a similar high burden of asthma exacerbations as those who initiated a biologic therapy. Other disease characteristics such as eosinophilic phenotype, serious infectious events, nasal polyps, airflow limitation and lack of asthma control appear to dictate biologic use.Keywords: severe asthma, biologics, real-world, treatment pattern, patient characteristics

Melina Gade Sikjær,1,2 Allan Klitgaard,1,2 Ole Hilberg,1,2 Anders Løkke1,2 1Department of Medicine, Lillebaelt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, DenmarkCorrespondence: Melina Gade Sikjær, Department of Regional Health Research, University of Southern Denmark, J.B.Winsløws vej 19, 3, Odense, 5000, Denmark, Email melina.gade.sikjaer@rsyd.dkBackground: There is sparse literature on parental chronic obstructive pulmonary disease (COPD) as a risk factor for the development of COPD in adult offspring, and the impact on disease severity. We aimed to map the literature reporting on the prevalence of and/or association between parental COPD and COPD in offspring, and to evaluate whether or not the literature reports on the severity of COPD or other health-related outcomes in offspring with parental COPD.Methods: A systematic literature search in Embase and Ovid MEDLINE was performed in June 2021. Search terms revolved around COPD and predisposition.Results: Thirteen studies were identified: 10 case–control studies, two cross-sectional studies and one cohort study. Population size varied from 44 to 2668 offspring cases; the distribution of female cases varied from 5% to 80% and mean age ranged from 27 to 65. Nine studies used an antecedents approach and evaluated the prevalence of parental COPD in patients with COPD, which ranged from 19% to 58%. Four studies used a descendants approach, by identifying patients with COPD and subsequently evaluated prevalence of COPD in their offspring, and found a prevalence of 0% to 17%. Apart from one, all the studies found an increased odds ratio for COPD in individuals with parental COPD. Four studies reported on parental smoking history and nine studies reported on smoking history in offspring. Three studies evaluated the association between parental COPD and COPD-related outcomes in patients with COPD.Conclusion: This review indicates that parental COPD is associated with a higher risk of COPD in offspring. The literature is sparse, and we identified a knowledge gap on whether parental COPD is a risk factor for severe COPD and other health conditions in offspring.Keywords: COPD severity, disease predisposition, familial predisposition, family history

Anders Løkke,1,2 Ole Hilberg,1,2 Peter Lange,3,4 Rikke Ibsen,5 Georgios Stratelis,6,7 Sofie de Fine Licht,6 Jesper Lykkegaard8 1Department of Medicine, Little Belt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Medical Department, Copenhagen University Hospital-Herlev, Herlev, Denmark; 4Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; 5i2Minds, Aarhus, Denmark; 6AstraZeneca Nordic, Södertälje, Sweden; 7Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden; 8Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, Odense, DenmarkCorrespondence: Anders Løkke, Email Anders.Lokke@rsyd.dkIntroduction: Studies have shown that exacerbation in chronic obstructive pulmonary disease (COPD) increases the risk of further exacerbations. Our aim was to investigate the impact of a single moderate exacerbation on the odds of subsequent exacerbations and death in GOLD B COPD patients.Methods: This hospital-based nationwide, cohort study in Denmark included all patients ≥ 40 years of age with an in- and/or outpatient ICD-10 J44 diagnosis (COPD Register, 2008– 2014). Index was date of first registered modified Medical Research Council (mMRC) score ≥ 2; baseline period was 12 months pre-index. At index, patients were grouped as: B0, no exacerbation; and B1, one moderate exacerbation during the previous year, and followed for three consecutive years in 2008– 2017 for development of moderate- (short-term use of prednisolone or prednisone) and severe (emergency visit or hospitalization) exacerbations and death. Using B0 as reference, the odds ratio (OR) for exacerbation and death in GOLD B1 was estimated with multinominal logistic regression and a Cox model estimated the hazard ratio for exacerbation accounting for recurrent events.Results: In total, 8,453 patients (mean age 70 years, 51% male) were included, of which GOLD B0 4,545 and GOLD B1 3,908 patients. During the 3-year follow-up, 34.1% and 24.9% of GOLD B0 and B1, respectively, had none or one moderate exacerbation whereas 61.9% and 71.2% of B0 and B1, respectively, had a severe trajectory with multiple moderate and/or a severe exacerbation or died. In B1 patients, the OR for 1 moderate, ≥ 2 moderate exacerbations, ≥ 1 severe exacerbation was 1.58 [CI 1.33– 1.87], 2.60 [2.19– 3.08], 2.08 [1.76– 2.45], respectively, and 1.85 [1.57– 2.17] for death compared with B0.Conclusion: One moderate exacerbation in COPD patients with high symptom burden increases the odds of subsequent exacerbations and death during the three following years. The results emphasize the importance of preventing exacerbations in GOLD B patients.Keywords: COPD, exacerbation, dyspnea, GOLD, mortality, epidemiology

Ayse Dudu Altintas Dogan,1– 3 Ole Hilberg,2,3 Søren Hess,2,4 Torben Tranborg Jensen,1 Else-Marie Bladbjerg,2,5 Claus Bogh Juhl1,2,6 1Department of Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark; 2Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; 3Department of Medicine, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark; 4Department of Radiology and Nuclear Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark; 5Unit for Thrombosis Research, Department of Clinical Biochemistry, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark; 6Steno Diabetes Center, Odense, DenmarkCorrespondence: Ayse Dudu Altintas Dogan, Department of Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Finsensgade 35, Esbjerg, 6700, Denmark, Tel +45 22 71 50 90, Email ayse.dudu.altintas.dogans@rsyd.dkPurpose: Chronic obstructive pulmonary disease (COPD) affects millions of people worldwide. Obesity is commonly seen concomitantly with COPD. People with COPD have reduced quality of life, reduced physical activity, chronic respiratory symptoms, and may suffer from frequent clinical exacerbations. Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved for weight loss and treatment of type-2 diabetes mellitus. In addition, liraglutide exerts anti-inflammatory actions by reducing IL-6 and MCP-1 levels. We investigated the effect of liraglutide on pulmonary function in people suffering from obesity and COPD.Patients and Methods: In this controlled, double-blind trial, 40 people with obesity and COPD from two outpatient clinics were allocated randomly to receive liraglutide (3.0 mg, s.c.) or placebo (s.c.) for 40 weeks. At baseline and after 4, 20, 40, and 44 weeks, participants underwent pulmonary-function tests, 6-min walking test, and replied to a questionnaire regarding the clinical impact of COPD (COPD assessment test (CAT)-score).Results: Compared with placebo, liraglutide use resulted in significant weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score. We found no significant changes in forced expiratory volume in one second (FEV1), FEV1/FVC, or 6-min walking distance.Conclusion: In patients suffering from obesity and COPD, 40 weeks of treatment with liraglutide improved some measures of pulmonary function. Our study suggests that liraglutide at 3.0 mg may be appropriate treatment in patients with obesity and COPD.Keywords: GLP-1 RA, COPD, obesity, inflammation, spirometry

Dea Kejlberg Andelius,1 Ole Hilberg,2,3 Rikke Ibsen,4 Anders Løkke2,3 1Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark; 2Department of Medicine, Vejle, Little Belt Hospital, Vejle, Denmark; 3Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 4i2minds, Aarhus, 8000, DenmarkCorrespondence: Dea Kejlberg Andelius Email dea-jensen@hotmail.comBackground: Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that is mainly caused by smoking, and most patients with COPD are either former or current smokers. The optimal way to slow down disease progression and reduce overall mortality is for patients to stop smoking. Patients with COPD are known to have lower socio-economic status and to be more nicotine-dependent than most other smokers and therefore face difficulties when attempting to quit smoking. Pharmacological smoking cessation treatment is known to be the most effective. However, the extent to which this treatment is actually offered to Danish smokers with COPD is unknown.Aim: The aim of this study was to investigate if patients with COPD were more likely to redeem a prescription for smoking cessation medication compared with matched controls.Materials and Methods: The study was designed as a registry-based, non-interventional case-control study. All Danish patients with COPD (ICD-10-code J 44 chronic obstructive pulmonary disease) diagnosed between 2009 and 2015 were included (130,797 cases). Controls (252,216) were matched on age, gender and geography. Primary outcome was the number of redeemed prescriptions for smoking cessation medication.Results: We found that 12% of patients with COPD redeemed a prescription for smoking cessation medication during the eight-year study period. The odds ratio (OR) for redeeming a prescription on smoking cessation medicine was OR 6.22 for patients with COPD compared with their matched controls. We also found that patients with COPD were more likely to redeem smoking cessation medication if they were younger, female or single.Conclusion: There is substantial room for improvement with respect to pharmacological smoking cessation treatment in Danish patients with COPD. In-depth knowledge of factors contributing to the patients choice of smoking cessation treatment might allow for more personalized guidance of patients with COPD.Keywords: nicotine, bupropion, varenicline, smoking cessation, COPD

Anders Løkke,1,2 Peter Lange,3,4 Jesper Lykkegaard,5 Rikke Ibsen,6 Maria Andersson,7 Sofie de Fine Licht,8 Ole Hilberg1,2 1Department of Medicine, Little Belt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Medical Department, Copenhagen University Hospital-Herlev, Herlev, Denmark; 4Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; 5Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark; 6i2Minds, Aarhus, Denmark; 7AstraZeneca Nordic, IVS & Health Economics, Södertälje, Sweden; 8AstraZeneca Nordic,Medical & Regulatory, Södertälje, SwedenCorrespondence: Anders LøkkeUniversity of Southern Denmark, Odense, DenmarkEmail Aloekke@gmail.comBackground: Chronic Obstructive Pulmonary Disease (COPD) carries a considerable economic burden, both for individuals and societies. This study aimed to assess direct and indirect costs associated with COPD, and how costs vary across disease severity.Methods: This was a nationwide, population-based cohort study utilizing Danish health registries. Patients; ≥ 40 years of age, with an in- and/or outpatient diagnosis of COPD (ICD-10 J44) in 2008– 2016, were identified in the nationwide Danish COPD Registry. Included patients were matched 1:4 to a population-based non-COPD reference population of 196,623 individuals by sex, year of birth, co-habitation status, and municipality. Patients were grouped by disease severity according to different characteristics including GOLD groups A-D, based on moderate (short-term oral corticosteroid use), presence of severe exacerbations (emergency visit or hospitalization) and symptom score. Index was the date of the first outpatient visit with a symptom score registration. The costs were calculated during a 12 months post-index follow-up.Results: In all, 49,826 patients with COPD (mean age 69.2 years, 52% females) were included. Total annual costs, including direct costs, costs for elderly care, and costs for retirement home, were higher for patients with COPD (€ 28,969) compared with the reference population (€ 10,6913). In GOLD groups A-D, the total direct costs were A: € 8,766, B: € 13,060, C: € 11,113, and D: € 17,749, respectively. A major driver of direct costs was severe exacerbations. The mean costs per moderate and severe exacerbation were € 888 and € 7,091, respectively, during 28 days of follow-up. The costs for non-COPD-related Health Care Resource Utilization were higher than the COPD-related costs in GOLD groups A-C, but not in GOLD group D.Conclusion: In this nationwide real-world study, total direct costs were three-fold higher among patients with COPD compared with the reference population. Severe exacerbations were a major driver of the direct costs. The costs increased with increasing disease severity.Keywords: COPD, exacerbations, symptoms, cost, GOLD

Anne Orholm Nielsen,1 Ole Hilberg,2,3 Jens Ulrik Stæhr Jensen,4 Steffen Helmer Kristensen,5 Jannie Christina Frølund,2 Pernille Kølholt Langkilde,6 Anders Løkke2,3 1Department of Medicine, Zealand University Hospital, Roskilde, Denmark; 2Department of Medicine, Hospital Little Belt, Vejle, Denmark; 3Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 4Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University Hospital of Copenhagen, Copenhagen, Denmark; 5Department of Pulmonary Medicine, Aalborg University Hospital, Aalborg, Denmark; 6Department of Medicine, Hospital Little Belt, Kolding, DenmarkCorrespondence: Anne Orholm NielsenDepartment of Medicine, Zealand University Hospital, Roskilde, DenmarkEmail anne_orholm@hotmail.comBackground: Inhaled corticosteroids (ICS) are widely used in the treatment of chronic obstructive pulmonary disease (COPD), but recent studies have raised doubts whether all COPD patients will benefit from ICS. This study evaluates in a real-life setting the effects of ICS withdrawal in patients with COPD.Methods: The study was a prospective intervention study following patients with COPD for 6 months after abrupt withdrawal of ICS. FEV1 (L), blood eosinophilic count (x10E9/L) and number of exacerbations were measured at baseline, 1, 3 and 6 months after ICS withdrawal.Results: Ninety-six patients (56 females (57.4%), mean age 70 years (51– 94 years)) with COPD were included in the study. Eleven patients were excluded during the study period (7 patients died, 4 patients withdrew their consent during the study period). During the 6 months, 51 patients (60%) had resumed treatment with ICS, of whom 34 patients (68%) experienced an exacerbation during follow-up. No significant decline in FEV1 was seen in this group between baseline and after 6 months (ΔFEV1 0.07 L, p = 0.09). In the remaining 34 patients (40%) without ICS after 6 months of follow-up, 15 patients (44.1%) experienced an exacerbation. No significant decline was seen in FEV1 at baseline and after 6 months (ΔFEV1 0.04 L, p = 0.28). There were no statistically significant differences between the two groups in age (70.5 vs 69.6 years, p = 0.53), nor between FEV1 at baseline (0.96 L vs 1.00 L, p = 0.63) or eosinophilic count (0.25 x10E9/L vs 0.17 x10E9/L, p = 0.07).Conclusion: Abrupt withdrawal of ICS was possible in some patients. However, more than half of the patients resumed ICS during follow-up. Based on results from our study we were not able to foresee – from neither history of exacerbations nor eosinophilic count – whom will be able to manage without ICS and who will resume treatment with ICS.Keywords: COPD, inhaled corticosteroids, withdrawal, real-life setting

Mette Søgaard,1 Morten Madsen,1 Anders Løkke,2 Ole Hilberg,2 Henrik Toft Sørensen,1 Reimar W Thomsen1 1Department of Clinical Epidemiology, 2Department of Respiratory Medicine, Aarhus University Hospital, Aarhus C, Denmark Background: Pneumonia may be a major contributor to hospitalizations for chronic obstructive pulmonary disease (COPD) exacerbation and influence their outcomes.Methods: We examined hospitalization rates, health resource utilization, 30-day mortality, and risk of subsequent hospitalizations for COPD exacerbations with and without pneumonia in Denmark during 2006–2012.Results: We identified 179,759 hospitalizations for COPD exacerbations, including 52,520 first-time hospitalizations (29.2%). Pneumonia was frequent in first-time exacerbations (36.1%), but declined in successive exacerbations to 25.6% by the seventh or greater exacerbation. Pneumonic COPD exacerbations increased 20% from 0.92 per 1,000 population in 2006 to 1.10 per 1,000 population in 2012. Nonpneumonic exacerbations decreased by 6% from 1.74 per 1,000 population to 1.63 per 1,000 population during the same period. A number of markers of health resource utilization were more prevalent in pneumonic exacerbations than in nonpneumonic exacerbations: length of stay (median 7 vs 4 days), intensive care unit admission (7.7% vs 12.5%), and several acute procedures. Thirty-day mortality was 12.1% in first-time pneumonic COPD exacerbations versus 8.3% in first-time nonpneumonic cases (adjusted HR [aHR] 1.20, 95% confidence interval [CI] 1.17–1.24). Pneumonia also predicted increased mortality associated with a second exacerbation (aHR 1.14, 95% CI 1.11–1.18), and up to a seventh or greater exacerbation (aHR 1.10, 95% CI 1.07–1.13). In contrast, the aHR of a subsequent exacerbation was 8%–13% lower for patients with pneumonic exacerbations.Conclusions: Pneumonia is frequent among patients hospitalized for COPD exacerbations and is associated with increased health care utilization and higher mortality. Nonpneumonic COPD exacerbations predict increased risk of subsequent exacerbations. Keywords: COPD, exacerbation, pneumonia, incidence, mortality

Purpose of the study: Explore perceptions, expectations and challenges following a telerehabilitation programme using augmented reality glasses (ARG) in patients with idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD) or recently diagnosed myocardial infarction (MI). A qualitative approach was employed to track perspectives from a range of patients with chronic lung and/or heart diseases. COPD, IPF and MI outpatients from Denmark and Finland were invited to participate. Data were collected through focus group and semi-structured in-depth interviews. Qualitative analysis was performed using standard thematic analytical approaches. A topic guide was used to explore experiences and perceptions of the ARG telerehabilitation device among participants. Thirteen patients (4 MI, 2 IPF and 7 COPD), 3 women and 10 men aged 56 to 75 years (mean age 63.3 years) were allocated into one focus group (9 patients) and 4 interviews (4 patients). Twelve patients reported the added value of ARG and suggested constructive changes such as the adjustable screen/brightness, robust head fixation for exercise performance, easy to navigate interface and supported feedback based on exercise performance. Patients with chronic heart or lung diseases described the added value in an ARG telerehabilitation programme. Improvements for a future version of the ARG were suggested. Patients with chronic pulmonary and heart diseases have difficulties to change behaviour to a more active and healthy lifestyle, offers from the health sector to participate in rehabilitation programmes at the hospital are feasible and improves quality of life and exercise capacity. Not all the patients are capable of participating in such rehabilitation programmes due to frailty and long distance to the hospital. Telerehabilitation seems to be a potential treatment to cope with the needs expressed above. Patient involvement in the development of a telerehabilitation solution to empower chronic pulmonary and heart patients to train, ensures a positive contribution to the design of the expected augmented reality software and hardware envisioned solution for telerehabilitation. The development of a user-centered telerehabilitation platform responding to the preferences of patients with chronic disease will remove barriers that limit use and compliance and improve empowerment in future research projects. [ABSTRACT FROM AUTHOR]