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Miguel Román-Rodríguez,1,2 Ilona McMullan,3 Michelle Warner,3 Christopher H Compton,3 Ruth Tal-Singer,4 Jean M Orlow,5 MeiLan K Han6 1Centro de Salud Dra. Teresa Pique, Mallorca, Spain; 2Instituto de Investigación Sanitaria de las Islas Baleares (IdISBa), Mallorca, Spain; 3GSK, London, UK; 4Global Allergy and Airways Patient Platform, Vienna, Austria; 5COPD Patient and COPD Foundation Community Member, Miami, FL, USA; 6Division of Pulmonary and Critical Care Medicine, University of Michigan School of Medicine, MI, USACorrespondence: Miguel Román-Rodríguez, Centro de Salud Dra. Teresa Pique, Mallorca, Spain, Email miguel.roman@ibsalut.esPurpose: Asthma and chronic obstructive pulmonary disease (COPD) are associated with substantial morbidity and mortality. This analysis assessed patient, caregiver, and healthcare provider (HCP) opinions regarding asthma and COPD diagnosis and treatment, including inhaler device preferences.Patients and Methods: Insights were from: (1) face-to-face/telephone patient/HCP communications with GSK Global Medical Teams; (2) social media listening; (3) a self-completed online patient/caregiver survey. Data were anonymized and informed consent was provided. Qualitative outputs were extracted, analyzed inductively, and coded per key themes, such as treatment preferences (including perceptions of single inhaler triple therapy [SITT] versus multiple inhaler triple therapy [MITT]) and long-term treatment goals. Data could be assigned to ≥ 1 theme.Results: Overall, 2966 patient and HCP insights (patients, 1150; HCPs, 1816), 988 social media posts, and 44 survey responses (patients, 33; caregivers, 11) were included. Within this analysis, some patients delayed seeking medical advice due to lack of disease understanding and used alternative information sources to better understand treatment options (eg, social media). Patients preferred SITT over MITT in terms of convenience, ease of use, and perceived efficacy; some believed that MITT provided greater coverage due to frequent dosing. HCPs recognized the tendency of patient preferences to drive treatment decisions, and highlighted a reluctance to change therapy among some patients, particularly those well controlled in current therapy. Patients preferred therapies with a shorter onset of action. Patients tended to measure treatment success by symptom improvement and quality of life, whereas HCPs measured treatment success through clinical tests. HCPs reported a lack of patient awareness of the mortality risk associated with COPD.Conclusion: There is discordance between patient and HCP perceptions of treatment success and goals in asthma and COPD. Improved patient education and HCP-patient communication are needed to facilitate meaningful shared decision-making, optimize care plans, and provide early treatment options.Keywords: single inhaler triple therapy, multiple inhaler triple therapy, treatment goals, medical advice, patient education, quality of life

Masahiro Shinoda,1 Osamu Hataji,2 Motohiko Miura,3 Masaharu Kinoshita,4 Akira Mizoo,5 Kazunori Tobino,6 Toru Soutome,7 Takanobu Nishi,7 Takeo Ishii,7 Bruce E Miller,8 Ruth Tal-Singer,8 Ryan Tomlinson,8 Taizo Matsuki,7 Paul W Jones,9 Yoko Shibata10 1Department of Respiratory Medicine, Tokyo Shinagawa Hospital, Shinagawa, Tokyo, Japan; 2Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Mie, Japan; 3Department of Respiratory Medicine, Tohoku Rosai Hospital, Sendai, Miyagi, Japan; 4Department of Respiratory Medicine, Nagata Hospital, Yanagawa, Fukuoka, Japan; 5Department of Pulmonary Medicine Japan, Japan Community Healthcare Organization Tokyo Shinjuku Medical Center, Shinjuku, Tokyo, Japan; 6Department of Respiratory Medicine, Iizuka Hospital, Iizuka, Fukuoka, Japan; 7Japan Medical & Development, GSK K.K, Minato-Ku, Tokyo, Japan; 8GSK Pharma R&D, Collegeville, PA, USA; 9General Medicine, GSK, Brentford, Middlesex, UK; 10Department of Pulmonary Medicine, Fukushima Medical University, Fukushima, JapanCorrespondence: Taizo Matsuki, Value Evidence Outcomes, Japan Medical & Development, GSK K.K, Akasaka Intercity AIR 1-8-1 Akasaka, Minato-Ku, Tokyo, 107-0052, Japan, Tel +81-8036928935, Email taizo.2.matsuki@gsk.comBackground: Telemedicine may help the detection of symptom worsening in patients with chronic obstructive pulmonary disease (COPD), potentially resulting in improved outcomes. This study aimed to determine the feasibility and acceptability of telemedicine among patients with COPD and physicians and facility staff in Japan.Methods: This was a 52-week multicenter, prospective, single-arm, feasibility and acceptability cohort study of Japanese patients ≥ 40 years of age with COPD or asthma-COPD overlap. Participants underwent training to use YaDoc, a telemedicine smartphone App, which included seven daily symptom questions and weekly COPD Assessment Test (CAT) questions. The primary endpoint was participant compliance for required question completion. The secondary endpoint was participant and physician/facility staff acceptability of YaDoc based on questionnaires completed at Week 52. The impact of the Japanese COVID-19 pandemic state of emergency on results was also assessed.Results: Of the 84 participants enrolled (mean age: 68.7 years, 88% male), 72 participants completed the study. Completion was high in the first six months but fell after that. Median (interquartile range [IQR]) compliance for daily questionnaire entry was 66.6% (31.0– 91.8) and 81.0% (45.3– 94.3) for weekly CAT entry. Positive participant responses to the exit questionnaire were highest regarding YaDoc ease of use (83.8%), positive impact on managing health (58.8%), and overall satisfaction (53.8%). Of the 26 physicians and facility staff enrolled, 24 completed the study. Of these, the majority (66.7%) responded positively regarding app facilitation of communication between physicians and participants to manage disease. Compliance was similar before and after the first COVID-19 state of emergency in Japan.Conclusion: Daily telemedicine monitoring is potentially feasible and acceptable to both patients and physicians in the management of COPD. These results may inform potential use of telemedicine in clinical practice and design of future studies.Clinical Trial Registration: JapicCTI-194916.Keywords: Japan, patient-reported outcome measure, feasibility, acceptability, telemonitoring, smartphone

Toshihiko Kaise,1 Eishin Sakihara,2 Kentaro Tamaki,3 Hiroaki Miyata,4 Norimichi Hirahara,4 Oksana Kirichek,5 Ryosuke Tawara,1 Shoko Akiyama,1 Masayuki Katsumata,1 Mei Haruya,6 Takeo Ishii,7 Edgar P Simard,8 Bruce E Miller,8 Ruth Tal-Singer8 1Japan Development, GSK, Tokyo, Japan; 2Lifestyle Related Disease Medical Center, Naha Medical Association, Okinawa, Japan; 3Department of Breast Surgery, Nahanishi Clinic, Okinawa, Japan; 4Health Policy and Management, School of Medicine, Keio University, Tokyo, Japan; 5Value Evidence and Outcomes, GSK, Stockley Park, UK; 6Government Affairs and Market Access, GSK, Tokyo, Japan; 7Medical Japan, GSK, Tokyo, Japan; 8Value Evidence and Outcomes, GSK, Collegeville, PA, USACorrespondence: Toshihiko KaiseJapan Development, GSK, Tokyo, JapanTel +81 80 5927 9500Fax +81 3 4231 5993Email toshihiko.kaise@gsk.comPurpose: Many individuals with obstructive airway disease (OAD), including chronic obstructive pulmonary disease (COPD) and asthma, remain undiagnosed, despite the potential for reducing disease burden through early detection and treatment. OCEAN aimed to determine the prevalence of, and characteristics associated with, impaired lung function in a Japanese population, with the goal of improving strategies for early OAD detection.Methods: OCEAN was an observational, cross-sectional study in sequentially recruited Japanese individuals ≥ 40 years of age undergoing routine health examinations. Participants completed screening questionnaires and spirometry testing. Airflow limitation was defined as forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7 by pre-bronchodilator spirometry. Preserved ratio impaired spirometry (PRISm) was defined as FEV1/FVC ≥ 0.7 and FEV1 < 80% predicted. The primary endpoint was prevalence of spirometry-based airflow limitation and PRISm. The characteristics of study participants were reported as secondary endpoints.Results: Overall, 2518 individuals were included; 79% were < 60 years of age (mean 52.0 years). Airflow limitation and PRISm were observed in 52 (2.1%) and 420 (16.7%) participants, respectively. FEV1 in the PRISm group was between that in the no airflow limitation/PRISm and airflow limitation groups, FVC was similar in the PRISm and airflow limitation groups. The PRISm group had higher mean body mass index and a higher proportion of comorbid metabolic disease compared with the airflow limitation group. The prevalence of airflow limitation and PRISm was highest among current smokers (3.9% and 21.3%, respectively) versus former or never smokers.Conclusion: A significant proportion of Japanese individuals < 60 years of age attending their annual health examination had impaired lung function (airflow limitation and PRISm); prevalence was highest among current smokers. These findings support screening of current or former smokers ≥ 40 years of age using patient-reported questionnaires to inform the need for spirometry to confirm an OAD diagnosis.Keywords: CAPTURE, CAAT, PRISm, COPD-Q, Japan, airflow limitation

Yisha Li,1 Margaret Ragland,1 Erin Austin,2 Kendra Young,1 Katherine Pratte,3 John E Hokanson,1 Terri H Beaty,4 Elizabeth A Regan,3 Stephen I Rennard,5 Christina Wern,6 Michael R Jacobs,7 Ruth Tal-Singer,8 Barry J Make,3 Gregory L Kinney1 On Behalf of theCOPDGene investigators1Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; 2Mathematical and Statistical Sciences, University of Colorado Denver, Denver, CO, USA; 3National Jewish Health, Denver, CO, USA; 4Bloomberg School of Public Health, University of John Hopkins, Baltimore, MD, USA; 5Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NB, USA; 6Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA; 7School of Pharmacy, Temple University, PA, Pennsylvania, USA; 8COPD Foundation, Washington, D.C., USACorrespondence: Gregory L KinneyDepartment of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USATel +1 303-724-4437Email GREG.KINNEY@CUANSCHUTZ.EDUPurpose: Medication patterns include all medications in an individual’s clinical profile. We aimed to identify chronic co-morbidity treatment patterns through medication use among COPDGene participants and determine whether these patterns were associated with mortality, acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and quality of life.Materials and Methods: Participants analyzed here completed Phase 1 (P1) and/or Phase 2 (P2) of COPDGene. Latent class analysis (LCA) was used to identify medication patterns and assign individuals into unobserved LCA classes. Mortality, AECOPD, and the St. George’s Respiratory Questionnaire (SGRQ) health status were compared in different LCA classes through survival analysis, logistic regression, and Kruskal–Wallis test, respectively.Results: LCA identified 8 medication patterns from 32 classes of chronic comorbid medications. A total of 8110 out of 10,127 participants with complete covariate information were included. Survival analysis adjusted for covariates showed, compared to a low medication use class, mortality was highest in participants with hypertension+diabetes+statin+antiplatelet medication group. Participants in hypertension+SSRI+statin medication group had the highest odds of AECOPD and the highest SGRQ score at both P1 and P2.Conclusion: Medication pattern can serve as a good indicator of an individual’s comorbidities profile and improves models predicting clinical outcomes.Keywords: COPDGene, co-morbidities, latent class analysis, medication patterns, mortality

Marni Stott-Miller,1 Hana Müllerová,2 Bruce Miller,3 Maggie Tabberer,4 Céline El Baou,5 Tom Keeley,4 Fernando J Martinez,6 Meilan Han,7 Mark Dransfield,8 Nadia N Hansel,9 Christopher B Cooper,10 Prescott Woodruff,11 Victor E Ortega,12 Alejandro P Comellas,13 Robert Paine III,14 Richard E Kanner,14 Wayne Anderson,15 M Bradley Drummond,15 Victor Kim,16 Ruth Tal-Singer,17 Aili L Lazaar3 1GSK R&D, Epidemiology: Value, Evidence and Outcomes, Uxbridge, UK; 2AstraZeneca, Cambridge, UK; 3GSK R&D, Discovery Medicine, Collegeville, PA, USA; 4GSK R&D Patient-Centred Outcomes: Value, Evidence and Outcomes, Uxbridge, UK; 5CEBSTAT Consultancy Ltd, London, UK; 6Cornell Medical College, New York, NY, USA; 7Division of Pulmonary and Critical Care at the University of Michigan, Ann Arbor, MI, USA; 8Children’s of Alabama, Children’s Health Research Unit/University of Alabama, Birmingham, AB, USA; 9Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA; 10David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 11UCSF Department of Medicine, San Francisco, CA, USA; 12Wake Forest School of Medicine, Winston Salem, NC, USA; 13Carver College of Medicine, University of Iowa, Iowa City, IA, USA; 14Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, UT, USA; 15Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 16Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; 17COPD Foundation, Washington, DC, USACorrespondence: Aili L Lazaar GSK, 1250 S. Collegeville Road, Collegeville, PA 19426-0989, USATel +1 484-923-3730Email Aili.L.Lazaar@gsk.comBackground: Chronic cough and phlegm are frequently reported chronic obstructive pulmonary disease (COPD) symptoms. Prior research classified chronic mucus hypersecretion (CMH) based on the presence of these symptoms for ≥ 3 months, called chronic bronchitis (CB) if respiratory infection symptoms were present for 1– 2 years (Medical Research Council [MRC] definition). We explored whether the COPD Assessment Test (CAT), a simple measure developed for routine clinical use, captures CMH populations and outcomes similarly to MRC and St. George’s Respiratory Questionnaire (SGRQ) definitions.Methods: We identified CMH in the SPIROMICS COPD cohort using (a) MRC definitions, (b) SGRQ questions for cough and phlegm (both as most/several days a week), and (c) CAT cough and phlegm questions. We determined optimal cut-points for CAT items and described exacerbation frequencies for different CMH definitions. Moderate exacerbations required a new prescription for antibiotics/oral corticosteroids or emergency department visit; severe exacerbations required hospitalization. Results were stratified by smoking status.Results: In a population of 1431 participants (57% male; mean FEV1% predicted 61%), 47% and 49% of evaluable participants had SGRQ- or CAT-defined CMH, respectively. A cut-point of ≥ 2 for cough and phlegm items defined CMH in CAT. Among SGRQ-CMH+ participants, 80% were also defined as CMH+ by the CAT. CMH+ participants were more likely to be current smokers. A higher exacerbation frequency was observed for presence of CMH+ versus CMH− in the year prior to baseline for all CMH definitions; this trend continued across 3 years of follow-up, regardless of smoking status.Conclusion: Items from the CAT identified SGRQ-defined CMH, a frequent COPD trait that correlated with exacerbation frequency. The CAT is a short, simple questionnaire and a potentially valuable tool for telemedicine or real-world trials. CAT-based CMH is a novel approach for identifying clinically important characteristics in COPD that can be ascertained in these settings.Keywords: COPD, SGRQ, exacerbation, CAT, cough, phlegm

Lasse L Langholm,1,2 Sarah Rank Rønnow,1,3 Jannie MB Sand,1 Diana Julie Leeming,1 Ruth Tal-Singer,4 Bruce E Miller,4 Jørgen Vestbo,5 Morten A Karsdal,1 Tina Manon-Jensen1 1Nordic Bioscience A/S, Herlev, Denmark; 2University of Copenhagen, Faculty of Health and Medical Sciences, Department of Biomedical Sciences, Copenhagen, Denmark; 3University of Southern Denmark, The Faculty of Health Science, Odense, Denmark; 4Respiratory Medical Innovation, Value Evidence & Outcomes, GSK R&D, Collegeville, PA, USA; 5Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and Manchester University NHS Foundation Trust, Manchester, UKCorrespondence: Lasse L LangholmNordic Bioscience A/S, Herlev Hovedgade 205-207, Herlev 2730, DenmarkTel +45 4452 5252Fax +45 4452 5251Email lla@nordicbio.comBackground: Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation and lung tissue deterioration. Given the high vascularity of the lung, von Willebrand factor (VWF), a central component of wound healing initiation, has previously been assessed in COPD. VWF processing, which is crucial for regulating the primary response of wound healing, has not been assessed directly. Therefore, this study aimed to characterize wound healing initiation in COPD using dynamic VWF-processing biomarkers and to evaluate how these relate to disease severity and mortality.Methods: A cross-sectional analysis of plasma samples from the ECLIPSE study collected at year 1 from moderate to very severe COPD subjects (GOLD 2– 4, n=984) was performed. We applied competitive neo-epitope ELISAs specifically targeting the formation of and ADAMTS13-processed form of VWF, VWF-N and VWF-A, respectively.Results: VWF-A and VWF-N were significantly increased (VWF-N, p=0.01; VWF-A, p=0.0001) in plasma of symptomatic (mMRC score ≥ 2) compared to asymptomatic/mild symptomatic COPD subjects. Increased VWF-N and VWF-A levels were specifically associated with emphysema (VWF-N, p< 0.0001) or prior exacerbations (VWF-A, p=0.01). When dichotomized, high levels of both biomarkers were associated with increased risk of all-cause mortality (VWF-N, HR 3.5; VWF-A, HR 2.64).Conclusion: We demonstrate that changes in VWF processing were related to different pathophysiological aspects of COPD. VWF-N relates to the chronic condition of emphysema, while VWF-A was associated with the more acute events of exacerbations. This study indicates that VWF-A and VWF-N may be relevant markers for characterization of disease phenotype and are associated with mortality in COPD.Study Identifier: NCT00292552; GSK study code SCO104960.Keywords: von Willebrand factor processing, COPD, emphysema, exacerbations, increased mortality risk

Background: Chronic inducible urticaria (CIndU) is a subtype of chronic urticaria (CU) which require specific physical or non‐physical triggers to occur. They may be isolated or may coexist with chronic spontaneous urticaria (CSU). Despite their frequent appearance in dermatology clinics, there is scarce information on the distinguishing features among the most common subtypes of CIndU as well as isolated CIndU versus CSU plus CIndU. Objectives: To compare clinical and laboratory characteristics, and comorbid conditions among the most common CIndU types and isolated CIndU versus CSU plus CIndU. Methods: We retrospectively analysed CIndU patients and compared patients' demographic, clinical and laboratory characteristics across isolated CIndU, CSU plus CIndU, symptomatic dermographism (SD), cold urticaria (ColdU) and cholinergic urticaria (ChoU). Results: A total of 423 patients (~70% isolated CIndU, ~30% CSU plus CIndU, ~5% mixed CIndU subtypes) were included in the study. The most frequent CIndU subtypes were SD (68.6%; 290/423), ColdU (11.4%; 48/423) and ChoU (10.9%; 46/423). Isolated CIndU patients were younger than CSU plus CIndU (33.74 ± 12.72 vs. 37.06 ± 11.84, p = 0.010). Angioedema, emergency referrals, need for systemic steroids, comorbid systemic disorders were more frequent and baseline urticaria control test scores were lower in CSU plus CIndU patients (vs. CIndU, p < 0.001, p = 0.008, p < 0.001, p = 0.031, p = 0.036, respectively). Among CIndU subtypes, ChoU patients were younger (24.9 ± 12.2 vs. 34.47 ± 12.12 vs. 31.38 ± 14.95; p < 0.001) and had male predominance (p < 0.001) while SD patients had no angioedema (p < 0.001) and had higher frequency of increased total IgE levels (p = 0.006). Conclusions: Isolated CIndU and CSU plus CIndU seems to be different endotypes of CU where CSU plus CIndU presents a more severe and refractory course. There are distinctive features of each CIndU subtype. These suggest involvement of different pathomechanistic pathways in these subtypes that need to be clarified in future studies. [ABSTRACT FROM AUTHOR]

Deepa Valvi1, David M Mannino1,2, Hana Müllerova3, Ruth Tal-Singer41Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA; 2Department of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky College of Medicine, Lexington, KY, USA; 3GlaxoSmithKline Research and Development, Worldwide Epidemiology, Stockley Park, Middlesex, UK; 4GlaxoSmithKline Research and Development, Respiratory Therapy Area Unit, King of Prussia, PA, USABackground: Fibrinogen is a marker of systemic inflammation and may be important in the pathogenesis and progression of chronic obstructive pulmonary disease (COPD).Methods: We used baseline data from Atherosclerosis Risk in Communities and Cardiovascular Health Studies to determine the relation between fibrinogen levels and COPD and to examine how fibrinogen levels at baseline affected outcomes of death, development of COPD, lung function decline, and COPD-hospitalizations.Results: Our study sample included 20,192 subjects, of whom 2995 died during the follow-up period. The mean fibrinogen level was 307.6 mg/dL and 10% of the sample had levels >393.0 mg/dL. Subjects with Stage 3 or 4 COPD were more likely to have a fibrinogen level >393.0 mg/dL (odds ratio 2.28, 95% confidence interval [CI]: 1.79–2.95). In the longitudinal adjusted models, fibrinogen levels >393 mg/dL predicted mortality (hazards ratio 1.54, 95% CI: 1.39–1.70), COPD-related hospitalization (hazards ratio 1.45, 95% CI: 1.27–1.67), and incident Stage 2 COPD (odds ratio 1.36, 95% CI: 1.07–1.74). Similar findings were seen with continuous fibrinogen levels.Conclusion: In the Atherosclerosis Risk in Communities/Cardiovascular Health Studies cohort data, higher fibrinogen levels are predictors of mortality, COPD-related hospitalizations, and incident Stage 2 COPD.Keywords: COPD, fibrinogen, epidemiology, mortality, hospitalization

Describes the formative evaluation of a multimedia computer system that provides remedial support for university students learning concepts concerning the structure and function of the human brain and describes usability studies of the system using the Software Usability Measurement Inventory (SUMI). Analysis of SUMI items and the student questionnaire are appended. (LRW)