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Victoria Federico Paly,1 Laura Amanda Vallejo-Aparicio,2 Alan Martin,3 José Luis Izquierdo,4 Juan Antonio Riesco,5 Juan José Soler-Cataluña,6 Catarina Abreu,7 Chandroday Biswas,8 Afisi S Ismaila9,10 1ICON plc, Philadelphia, PA, USA; 2GSK, Madrid, Spain; 3GSK, Brentford, UK; 4Hospital Universitario de Guadalajara, Guadalajara, Spain; 5Hospital San Pedro de Alcántara, Cáceres, Spain; 6Hospital Arnau de Vilanova, Valencia, Spain; 7ICON Plc, New York, NY, USA; 8ICON Plc, Bengaluru, Karnataka, India; 9Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 10Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GSK, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: Given between-country differences in healthcare systems, treatment costs, and disease management guidelines, country-specific cost-effectiveness analyses are important. This study evaluated the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI among patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations from a Spanish healthcare system perspective.Patients and Methods: Baseline data and treatment effects from the IMPACT trial were populated into the validated GALAXY COPD progression model. Utilities were estimated using Spanish observational data. Direct healthcare costs (2019 €) were informed by Spanish public sources. A 3% discount rate for costs and benefits was applied. The time horizon and treatment duration were 3 years (base case). One-way sensitivity, scenario, and probabilistic sensitivity analyses were performed.Results: FF/UMEC/VI treatment resulted in fewer exacerbations over 3 years (4.130 vs 3.648) versus FF/VI, with a mean (95% confidence interval [CI]) incremental cost of € 444 (€ 149, € 713) per patient and benefit of 0.064 (0.053, 0.076) quality-adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of € 6887 per QALY gained. FF/UMEC/VI was a dominant treatment strategy versus UMEC/VI, resulting in fewer exacerbations (4.130 vs 3.360), with a mean (95% CI) incremental cost of –€ 450 (–€ 844, –€ 149) and benefit of 0.054 (0.043, 0.064) QALYs. FF/UMEC/VI was cost-effective versus FF/VI and UMEC/VI across all analyses.Conclusion: FF/UMEC/VI was predicted to be a cost-effective treatment option versus FF/VI or UMEC/VI in symptomatic COPD patients at risk of exacerbations in Spain, across all scenarios and sensitivity analyses.Keywords: chronic obstructive pulmonary disease, cost-effectiveness, single-inhaler triple therapy, Spain, triple inhaled therapy

Resumen La nueva edicion de 2021 de la Guia Espanola de la EPOC (GesEPOC 2021) propone, junto al tratamiento farmacologico ajustado por estratificacion de riesgo y fenotipo, el abordaje personalizado de los rasgos tratables, definidos como una caracteristica (clinica, fisiologica o biologica) que se puede identificar mediante pruebas diagnosticas o biomarcadores y que tiene un tratamiento especifico. Existen algunos rasgos tratables que tienen un tratamiento no farmacologico y que no fueron contemplados en detalle en la guia, como puede ser la desnutricion, el sedentarismo, el enfisema o la insuficiencia respiratoria. En este capitulo de GesEPOC 2021 se presenta una actualizacion narrativa con recomendaciones sobre tratamiento dietetico, actividad fisica, rehabilitacion respiratoria, oxigenoterapia, ventilacion no invasiva, reduccion de volumen y trasplante pulmonar. Ademas, se incluye una pregunta PICO con recomendacion sobre el uso de oxigeno suplementario durante el ejercicio en pacientes con EPOC sin hipoxemia grave.

The Spanish COPD Guidelines (GesEPOC) were first published in 2012, and since then have undergone a series of updates incorporating new evidence on the diagnosis and treatment of COPD. GesEPOC was drawn up in partnership with scientific societies involved in the treatment of COPD and the Spanish Patients' Forum. Their recommendations are based on an evaluation of the evidence using GRADE methodology, and a narrative description of the evidence in areas in which GRADE cannot be applied. In this article, we summarize the recommendations on the pharmacological treatment of stable COPD based on 9 PICO questions. COPD treatment is a 4-step process: 1) diagnosis, 2) determination of the risk level, 3) initial and subsequent inhaled therapy, and 4) identification and management of treatable traits. For the selection of inhaled therapy, high-risk patients are divided into 3 phenotypes: non-exacerbator, eosinophilic exacerbator, and non-eosinophilic exacerbator. Some treatable traits are general and should be investigated in all patients, such as smoking or inhalation technique, while others affect severe patients in particular, such as chronic hypoxemia and chronic bronchial infection. COPD treatment is based on long-acting bronchodilators with single agents or in combination, depending on the patient's risk level. Eosinophilic exacerbators must receive inhaled corticosteroids, while non-eosinophilic exacerbators require a more detailed evaluation to choose the best therapeutic option. The new GesEPOC also includes recommendations on the withdrawal of inhaled corticosteroids and on indications for alpha-1 antitrypsin treatment. GesEPOC offers a more individualized approach to COPD treatment tailored according to the clinical characteristics of patients and their level of complexity.

[Introduction] Quantifying physical activity in chronic obstructive pulmonary disease (COPD) with questionnaires and activity monitors in clinical practice is challenging. The aim of the present study was to analyse the discriminant validity of a single clinical question for the screening of inactive individuals living with COPD., [Methods] A multicentre study was carried out in stable COPD individuals both in primary and tertiary care. Patients wore the Dynaport accelerometer for 8 days and then answered 5 physical activity questions developed for the study, referring to the week in which their physical activity was monitored. Receiver operating characteristic (ROC) curve analysis with physical activity level (PAL) as the gold standard reference was used to determine the best cut-off point for each of the 5 clinical physical activity questions tested., [Results] A total of 86 COPD participants were analysed (males 68.6%; mean (SD) age 66.6 (8.5) years; FEV1 50.9 (17.3)% predicted; mean of 7305 (3906) steps/day). Forty-two (48.8%) participants were considered physically inactive (PAL ≤ 1.69). Answers to 4 out of 5 questions significantly differed in active vs inactive patients. The Kappa index and ROC curves showed that the answer to the question “On average, how many minutes per day do you walk briskly?” had the best discriminative capacity for inactivity, with an area under the curve (AUC) (95% Confidence interval (CI)) of 0.73 (0.63– 0.84) and 30 min/day was identified as the best cut-off value (sensitivity (95% CI): 0.75 (0.60– 0.87); specificity: 0.76 (0.61– 0.88))., [Conclusion] The present results indicate that self-reported brisk walk time lower than 30 min/day may be a valid tool for the screening of inactivity in individuals living with COPD in routine care, if more detailed physical activity measures are not feasible., This study was funded by an unrestricted grant from Laboratorios Esteve (Barcelona, Spain).

The isolation of Pseudomonas aeruginosa (PA) in patients with chronic obstructive pulmonary disease (COPD) is associated with increased mortality. Yet, factors associated with first PA sputum isolation, and PA persistence have not been investigated before. The objective of the present study was to investigate risk factors for new acquisition and persistence of PA infection and their relationship with all-cause mortality in patients with COPD. Post-hoc analysis of prospectively collected cohort of 170 COPD patients (GOLD II-IV) who were free of previous PA isolation and followed up every 3-6 months for 85 [50.25-110.25] months. PA was isolated for the first time in 41 patients (24.1%) after 36 [12-60] months of follow-up. Risk factor for first PA isolation were high cumulative smoking exposure, severe airflow limitation, previous severe exacerbations, high fibrinogen levels and previous isolation of Haemophilus Influenzae. PA was isolated again one or more times during follow-up in 58.5% of these patients. This was significantly associated with the presence of CT bronchiectasis and persistence of severe exacerbations, whereas the use of inhaled antibiotic treatment after the first PA isolation (at the discretion of the attending physician) reduced PA persistence. During follow-up, 79 patients (46.4%) died. A single PA isolation did not increase mortality, but PA persistence did (HR 3.06 [1.8-5.2], p = 0.001). We conclude that PA occurs frequently in clinically stable COPD patients, risk factors for a first PA isolation and PA persistence are different, and the latter (but not the former) is associated with increased all-cause mortality.

Juan José Soler-Cataluña,1 Luis Puente Maestu,2 Miguel Román Rodríguez,3 Cristóbal Esteban,4 Joaquín Gea,5 Roberto Bernabeu Mora,6 Eulogio Pleguezuelos Cobo,7 Julio Ancochea,8 Francisco García-Río9 1Hospital Arnau de Vilanova, Valencia, Spain; 2Hospital Gregorio Marañón, Madrid, Spain; 3Centro de Salud Son Pisà , Palma de Mallorca, Spain; 4Hospital de Galdakao, Bilbao (Vizcaya), Spain; 5Hospital del Mar, Barcelona, Spain; 6Hospital General Universitario Morales Meseguer, Murcia, Spain; 7Hospital de Mataró, Mataró (Barcelona), Spain; 8Hospital de La Princesa, Madrid, Spain; 9Hospital La Paz-IdiPAZ, Madrid, SpainCorrespondence: Francisco García-Río, Hospital La Paz, P.° de la Castellana, 261, Madrid, 28046, Spain, Tel +34 917 27 70 00, Email fgr01m@gmail.comPurpose: The Spanish Activity Questionnaire in COPD (SAQ-COPD) is a short, simple physical activity (PA) measurement instrument for patients with chronic obstructive pulmonary disease (COPD). In this study, we analyzed its validity and sensitivity to change.Methods: Prospective scale validation study. An accelerometer (DynaPort MoveMonitor®) and the Yale Physical Activity Survey (YPAS) were used as reference standards. The analyses examined the criterion validity (Spearman correlations), internal consistency (Cronbach’s alpha), factorial structure, test-retest reliability (intraclass correlation coefficient, ICC), sensitivity to change and receiver operating characteristic (ROC) curve to classify patients with low PA.Results: A total of 300 patients diagnosed with COPD were analyzed (73% males, mean age 66 ± 8 years, 40.3% with severe airflow limitation). Cronbach’s alpha was 0.60 and Spearman’s correlations with accelerometer measurements of PA [number of steps, metabolic equivalents (MET), physical activity level (PAL)] and YPAS ranged from 0.37 to 0.53 (all p < 0.001). ICC was 0.69 (95% CI 0.61– 0.74) and the area under the ROC curve to identify low PA was 0.65 (95% confidence interval: 0.58– 0.73). Significant variations in SAQ-COPD scores were found between groups defined by YPAS for change.Conclusion: The SAQ-COPD questionnaire is a valid instrument for classifying PA in patients with COPD. Correlations with other instruments provide criterion validity and also demonstrate good sensitivity to change.Keywords: physical activity, chronic obstructive pulmonary disease, SAQ-COPD, validity, reliability

Introduction Control status may be a useful tool to assess response to treatment at each clinical visit in COPD. Control status has demonstrated to have long-term predictive value for exacerbations, but there is no information about the short-term predictive value of the lack of control and changes in control status over time. Method Prospective, international, multicenter study aimed at describing the short-term (6 months) prognostic value of control status in patients with COPD. Patients with COPD were classified as controlled/uncontrolled at baseline and at 3,6-month follow-up visits using previously validated criteria of control. Moderate and severe exacerbation rates were compared between controlled and uncontrolled visits and between patients persistently controlled, uncontrolled and those changing control status over follow-up. Results A total of 267 patients were analyzed: 80 (29.8%) were persistently controlled, 43 (16%) persistently uncontrolled and 144 (53.7%) changed control status during follow-up. Persistently controlled patients were more frequently men, with lower (not increased) body mass index and higher FEV1(%). During the 6 months following an uncontrolled patient visit the odds ratio (OR) for presenting a moderate exacerbation was 3.41 (95% confidence interval (CI) 2.47–4.69) and OR = 4.25 (95%CI 2.48–7.27) for hospitalization compared with a controlled patient visit. Conclusions Evaluation of control status at each clinical visit provides relevant prognostic information about the risk of exacerbation in the next 6 months. Lack of control is a warning signal that should prompt investigation and action in order to achieve control status.

Physical capacity (PC) and daily physical activity (PA) are two crucial factors in the clinical course of COPD, although they do not always maintain a close relationship. The objectives were to evaluate the frequency of PC-PA dissociation in patients with COPD and subjects without airflow limitation (AL) and to identify its risk factors.A sample of 319 COPD patients and 399 subjects without AL was consecutively obtained from a population-based sample of 9092 subjects evaluated in the EPISCAN II study. Baseline evaluation included clinical questionnaires, lung function testing, blood analysis and low-dose computed tomography (CT) scan with evaluation of lung density and airway wall thickness. A distance walked in 6 min 70% predicted was considered an indicator of normal PC, while a Yale Physical Activity Survey summary index score51 was used to identify with sedentary lifestyle.166 COPD patients (52.0%) reported a sedentary lifestyle with evidence of preserved PC, while this phenomenon was present in 188 (47.1%) subjects without AL. In the COPD group, symptoms of chronic bronchitis, depression and elevated hematocrit and blood eosinophil count were identified as independent risk factors for PC-PA dissociation. In turn, in the subjects without AL, the risk factors for PC-PA dissociation were low fat-free mass, obesity and anxiety, as well as reduced levels of HDL-cholesterol and the absence of osteoporosis.Almost half of COPD patients and subjects without airflow limitation with preserved PC maintain a sedentary lifestyle, with different risk factors for sedentarism between both groups.

Background: Two previous national epidemiological studies, IBERPOC in 1997 and EPISCAN in 2007, determined the COPD burden in Spain. Changes in demographics and exposure to risk factors demand the periodic update of COPD prevalence and its determinants. Methods: EPISCAN II aimed to estimate the prevalence of COPD in the general population aged 40 years or older in all 17 regions of Spain. A random population screening sample, requiring 600 participants per region performed a questionnaire plus post-bronchodilator (post-BD) spirometry. Results: A total of 12,825 subjects were initially contacted, and 9433 (73.6%) agreed to participate, of whom 9092 performed a valid spirometry. Baseline characteristics were: 52.6% women, mean ± SD age 60 ± 11 years, 19.8% current- and 34.2% former-smokers. The prevalence of COPD measured by post-BD fixed ratio FEV1/FVC < 0.7 was 11.8% (95% C.I. 11.2–12.5) with a high variability by region (2.4-fold). Prevalence was 14.6% (95% C.I. 13.5–15.7) in males and 9.4% (95% C.I. 8.6–10.2) in females; according to the lower limit of normal (LLN) was 6.0% (95% C.I. 5.5–6.5) overall, by sex being 7.1% (95% C.I. 6.4–8.0) in males and 4.9% (95% C.I. 4.3–5.6) in females. Underdiagnosis of COPD was 74.7%. Cases with COPD were a mean of seven years older, more frequently male, of lower attained education, and with more smokers than the non-COPD population (p < 0.001). However, the number of cigarettes and pack-years in non-COPD participants was substantial, as it was the reported use of e-cigarettes (7.0% vs. 5.5%) (p = 0.045). There were also significant social and clinical differences including living alone, previous respiratory diagnoses, more comorbidities measured with the Charlson index, greater BODE and COTE scores, cognitive impairment, and depression (all p < 0.001). Conclusions: COPD remains prevalent in Spain and frequently underdiagnosed.

Resumen A pesar de que es conocido que la presencia cronica de microorganismos en las vias aereas de pacientes con enfermedad pulmonar obstructiva cronica (EPOC) en fase de estabilidad conlleva una evolucion desfavorable, ninguna guia de manejo de la enfermedad establece pautas sobre como diagnosticar y tratar este tipo de casos. Con la intencion de orientar a los profesionales, desde la Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) se ha elaborado un documento que pretende aportar respuestas clinicas sobre el manejo de pacientes con EPOC en los que se aislan microorganismos de forma puntual o persistente. Dado que la heterogeneidad de las evidencias cientificas disponibles no permite crear una Guia de Practica Clinica, se ha elaborado un documento basado en la literatura cientifica existente y/o en la propia experiencia clinica que aborda tanto la definicion de las diferentes situaciones clinicas como su diagnostico y manejo. El texto ha sido consensuado entre un amplio numero de neumologos con gran experiencia clinica y cientifica en este ambito. Este documento cuenta con el aval del Comite Cientifico de SEPAR.

Background The concept of clinical control has been proposed as an instrument for evaluating patients with COPD. However, the possible association between clinical control, reduced symptom severity and HRQoL has yet to be confirmed. Methods This multicentre, prospective and observational study was carried out in 15 pulmonology clinics in Spain. The patients were followed up for six months, with a baseline visit (V0), followed by visits at three months (V1) and six months (V2). Clinical control was determined at V1, with the application of both clinical criteria and the COPD assessment test (CAT). All patients reported their symptoms by a validated symptom diary (E-RS) using a portable device, and their HRQoL was assessed using the EQ5D questionnaire. The relationship between clinical control and E-RS and HRQoL during follow-up was assessed with t-test. Results A total of 126 patients were screened. After application of the inclusion/exclusion criteria, 93 were finally included (mean age 66 ± 8 years, 84.9% male), with a mean FEV1 predicted of 49.8% ± 16.5%. Of these patients, 44 (47.3%) achieved clinical control at V1, according to CAT criteria, and 50 (53.8%), according to clinical criteria. The E-RS scores differed between controlled and uncontrolled patients at all time points, both according to CAT (mean differences of -4.6, -5.6 and -6.2 units at V0, V1 and V2, respectively, p

Chronic airflow obstruction affects a wide range of airway diseases, the most frequent of which are asthma, COPD, and bronchiectasis; they are clearly identifiable in their extremes, but quite frequently overlap in some of their pathophysiological and clinical characteristics. This has generated the description of new mixed or overlapping disease phenotypes with no clear biological grounds. In this special article, a group of experts provides their perspective and proposes approaching the treatment of chronic airway disease (CAD) through the identification of a series of therapeutic goals (TG) linked to treatable traits (TT) - understood as clinical, physiological, or biological characteristics that are quantifiable using biomarkers. This therapeutic approach needs validating in a clinical trial with the strategy of identification of TG and treatment according to TT for each patient independently of their prior diagnosis.

Resumen: La imposición del estado de alarma por el Gobierno Español como principal medida para evitar el contagio ha supuesto un cambio en la aproximación clínica al paciente crónico. Aunque las nuevas tecnologías de la comunicación nos ofrecen numerosas formas de establecer un contacto directo, pero en la distancia, las peculiaridades del paciente con EPOC hacen que con frecuencia esta atención sanitaria se vea reducida al teléfono. El reto de atender a los pacientes con EPOC por teléfono supone una complejidad añadida a la atención sanitaria. La entrevista se realizará sin la exploración del paciente, sin nuevas pruebas complementarias y sin poder verificar la técnica inhalatoria. Por tanto, los sanitarios que realicen estas entrevistas deben estar entrenados para conseguir realizarla adecuadamente para permitir la toma de decisiones. Este documento va dirigido a profesionales sanitarios que tengan que realizar algún tipo de atención telefónica a pacientes con EPOC durante la pandemia de SARS-CoV-2 y se basa en la experiencia de sus autores en entrevistas telefónicas mantenidas durante esta pandemia. En él se resumen aspectos esenciales sobre cómo debe afrontar esta entrevista, cómo llevarla a cabo, qué aspectos se deben tener presentes, cómo organizarla y cómo informar a los pacientes. Es muy probable que a partir de ahora este tipo de entrevista tenga que generalizarse para la atención de nuestros pacientes, por lo que necesitamos aprender a estructurar muchas de las visitas clínicas que hasta ahora se hacían presenciales en un nuevo modelo de atención sanitaria. Abstract: The state of alarm declared by the Spanish government as the main measure for preventing contagion has involved a change in the clinical management of chronic patients. Although new communication technologies offer us many ways to establish direct but remote contact, the peculiarities of the COPD patient often mean that their healthcare is reduced to telephone calls. The challenge of caring for COPD patients is made even more complex when it has to be delivered over the phone. The interview must be conducted without examining the patient, without performing additional tests, and without checking their inhalation technique. Therefore, healthcare providers who conduct these interviews must be trained to perform them properly in order to make the right decisions. This document is aimed at healthcare professionals who need to provide some form of telephone care to COPD patients during the SARS-CoV-2 pandemic and is based on the authors’ experience in telephone interviews conducted during this period. It summarizes essential aspects of how this interview should be approached, how to conduct it, what factors should be kept in mind, how to organize the interview, and how to keep patients informed. It is very likely that from now on this type of interview will be common practice in the care of our patients, so we need to learn how to structure a new model of healthcare for many of the clinical visits that have until now been conducted face-to-face.

Melanie Schroeder,1 Nicole Benjamin,2 Laura Atienza,3 Chandroday Biswas,4 Alan Martin,5 John D Whalen,6 José Luis Izquierdo Alonso,7 Juan Antonio Riesco Miranda,8 Juan José Soler-Cataluña,9 Alicia Huerta,3 Afisi S Ismaila10,11 1Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK; 2Global Health Economics, ICON plc., Boston, MA, USA; 3Market Access, GlaxoSmithKline SA, Madrid, Spain; 4Global Health Economics, ICON plc., Bengaluru, Karnataka, India; 5Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK; 6Global Health Economics, ICON plc., Abingdon, UK; 7Pneumology, Hospital Universitario de Guadalajara, Guadalajara, Spain; 8Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, Spain; 9Pneumology Department, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain; 10Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA; 11Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaGlaxoSmithKline Plc., 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 (919) 315 8229Email afisi.s.ismaila@gsk.comPurpose: To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective.Patients and Methods: The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL (NCT02345161), which compared FF/UMEC/VI vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations. Treatment effects, extrapolated to 3 years, were based on Week 24 results in the FULFIL intent-to-treat population, including change in forced expiratory volume in 1 second, St. George’s Respiratory Questionnaire score, and exacerbation rates. Treatment, exacerbations, and COPD management costs (2019€) were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way sensitivity and scenario analyses, and probabilistic sensitivity analysis (PSA), were performed.Results: FF/UMEC/VI treatment led to fewer moderate and severe exacerbations (2.126 and 0.306, respectively) vs BUD/FOR (2.608 and 0.515, respectively), with a mean incremental cost of € 69 and gain of 0.107 QALYs, which resulted in an ICER of € 642 per QALY gained. In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs. Overall, 95% of 1000 PSA simulations resulted in an ICER less than € 11,000 per QALY gained for FF/UMEC/VI vs BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at a willingness-to-pay threshold of € 30,000 per QALY gained.Conclusion: At the accepted Spanish ICER threshold of € 30,000, FF/UMEC/VI represents a cost-effective treatment option vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations.Keywords: cost-utility analysis, health-related quality of life, incremental cost-effectiveness ratio, fluticasone furoate, vilanterol, umeclidinium

Introduction There is currently no universally accepted definition of asthma−COPD overlap (ACO). Objective To compare the prevalence of ACO in patients with asthma or COPD, and to assess their clinical characteristics and the capacity of the different definitions to predict the risk of exacerbation. Method Prospective observational study with a 12-month follow-up in an asthma cohort and a COPD cohort. Four diagnostic criteria were compared: A) the Spanish 2012 consensus; B) the 2016 international consensus; C) the 2017 consensus between the Spanish COPD guidelines (GesEPOC) and GEMA asthma guidelines; and D) the single criterion of ≥300 eosinophils/μL, proposed by GOLD 2019. The risk of exacerbations was evaluated in each group. Results A total of 345 patients were included, 233 (67.5%) with COPD and 112 (32.5%) with asthma, aged 63 ± 14 years, 70.4% men. Fifteen (4.3%) patients met the criteria for ACO according to the criteria described under A above; 30 (8.7%) with the criteria of B; 118 (34.2%) with the criteria of C; and 97 (28.1%), with the D criterion. The ACO-COPD subtype were older, had worse lung function, and an increased risk of exacerbation compared with the ACO-asthma group. Of all the definitions evaluated, those which distinguished a higher risk of exacerbations were the GesEPOC-GEMA consensus and the GOLD proposal. Conclusions The prevalence of ACO varies enormously depending on the diagnostic criteria used. The ACO population is heterogeneous, and the ACO-COPD subtype is very different from the ACO-asthma subtype. The definitions that include eosinophilia identify ACO patients with a greater risk of exacerbation.

Rationale: Treatment of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroids (ICS) is controversial, because it can reduce the risk of future exacerbations of the disease at the expense of increasing the risk of pneumonia.Objectives: To assess the relationship between the presence of chronic bronchial infection (CBI), reduced number of circulating eosinophils, ICS treatment, and the risk of pneumonia in patients with COPD.Methods: This was a post hoc long-term observational study of an historical cohort of 201 patients with COPD (Global Initiative for Chronic Obstructive Lung Disease II-IV) who were carefully characterized (including airway microbiology) and followed for a median of 84 months. Results were analyzed by multivariate Cox regression and network analysis.Measurements and Main Results: Mean age was 70.3 years, 90.5% of patients were male, mean FEV1 was 49%, 71.6% of patients were treated with ICS, 57.2% of them had bronchiectasis, and 20.9% had

Background Control has been proposed as a dynamic tool that can capture changes in the clinical status of patients with COPD. Methods This prospective, multicenter, observational study aimed to compare changes in control over a 3-month period with changes in risk level, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, and clinical phenotype (nonexacerbator, asthma-COPD overlap, or exacerbator with emphysema or with chronic bronchitis). Control was defined as the presence of low clinical impact, assessed according to the degree of dyspnea, use of rescue medication, physical activity and sputum color, and clinical stability assessed by clinical changes and exacerbations in the last 3 months. Impact and stability were alternatively assessed with COPD Assessment Test (CAT) scores. Results We included 354 patients, with a mean FEV1 of 49.8% ± 16.9%. At 3 months, the proportion of controlled patients was 50.3% according to clinical evaluation and 47.8% according to CAT score. Eighty-seven patients (29.2%) changed their control status as assessed by clinical variables, and 85 patients (28.5%) changed their status according to CAT score. In contrast, the risk level only changed in 26 patients (8.7%) (P Conclusions In only 3 months, almost one-third of patients experienced changes in their control status. Changes in control status were significantly more frequent than changes in phenotype, risk level, and GOLD stage, and resulted in significant changes in health status.

Resumen Introduccion En la actualidad no disponemos de una definicion de solapamiento asma-EPOC (ACO) universalmente aceptada. Objetivo Comparar la prevalencia del ACO en pacientes con asma o EPOC, valorar sus caracteristicas clinicas y la capacidad predictiva de riesgo de agudizacion de las diferentes definiciones. Metodo Estudio prospectivo observacional con seguimiento de 12 meses sobre una cohorte de asma y otra con EPOC. Se comparan 4 criterios diagnosticos: A) el consenso espanol del 2012; B) el consenso internacional del 2016; C) el consenso entre la guia espanola de la EPOC (GesEPOC) y la del asma (GEMA) del 2017; y D) el criterio unico de ≥ 300 eosinofilos/μl, propuesto por GOLD 2019. En cada grupo se evaluo el riesgo de agudizaciones. Resultados Se incluyeron 345 pacientes, 233 (67,5%) con EPOC y 112 (32,5%) con asma, con una edad de 63 ± 14 anos; el 70,4% eran hombres. Quince (4,3%) pacientes cumplian criterios de ACO con criterios A; 30 (8,7%) con los B; 118 (34,2%) con los C; y 97 (28,1%) con el criterio D. El subtipo ACO-EPOC presento mas edad, peor funcion pulmonar y mayor riesgo de agudizacion que los ACO-asma. De todas las definiciones evaluadas, las que presentaron mayor riesgo de agudizaciones fueron la del consenso GesEPOC-GEMA y la propuesta de GOLD. Conclusiones La prevalencia de ACO varia enormemente en funcion del criterio diagnostico utilizado. La poblacion de ACO es heterogenea, con un subtipo ACO-EPOC muy diferente al ACO-asma. Las definiciones que incluyen la eosinofilia identifican a los ACO de mas riesgo de agudizacion.

Borja G Cosio,1,2 Hanaa Shafiek,1,3 Nuria Toledo-Pons,1,2 Amanda Iglesias,1,2 Margalida Barcelo,1 Cristina Represas-Represas,4 Lorena Comeche,5 Pablo Catalan,6 Alberto Fernandez-Villar,4 Jose Luis Lopez- Campos,7 Jose Echave-Sustaeta,5 Juan Jose Soler-Cataluna8 1Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain; 2CIBERES-IDISBa, Palma de Mallorca, Spain; 3Chest Diseases Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt; 4Respiratory Medicine, Hospital Alvaro Cunqueiro, Vigo, Spain; 5Respiratory Medicine, Hospital Universitario Quironsalud Madrid, Madrid, Spain; 6Respiratory Medicine, Hospital General de Castellón, Castellón, Spain; 7Respiratory Medicine, Hospital Virgen del Rocio-CIBERES, Sevilla, Spain; 8Respiratory medicine, Hospital Arnau de Vilanova-CIBERES, Valencia, SpainCorrespondence: Borja G CosioHospital Universitario Son Espases, Ctra de Valldemossa 79, Palma de Mallorca, 07010, SpainTel +34 871 20 6714Email borja.cosio@ssib.esPurpose: Exacerbations of COPD (ECOPD) are a frequent cause of hospitalization that seemed to ameliorate during the COVID outbreak. We aimed to evaluate the clinical characteristics of COPD-related hospital admissions and mortality in relation to the presence of COVID-19.Patients and Methods: We conducted a case–control study of patients admitted in four teaching hospitals throughout Spain between March 15 and April 30, 2020. Hospital admissions of respiratory cause with and without PCR-proven SARS-CoV-2 infection in patients with COPD were evaluated. Baseline and episode-related clinical characteristics were analyzed. Logistic regression analysis was performed to evaluate the risk for mortality.Results: During the study period, 2101 patients were admitted for respiratory worsening, 1200 (57.1%) with COVID-19. A total of 228 (10.8%) were admitted due to COPD worsening, of whom 52 (22.8%) tested positive for COVID-19. COPD patients with COVID-19, when compared to those without COVID-19, were more frequently males with better lung function (FEV1 postbronchodilator 71% vs 46% respectively, p< 0.001) and had higher mortality (44.9% vs 13.6% respectively, p< 0.001) despite similar age, comorbidities, total days of hospitalization and admission to intensive care unit. COVID-19 and eosinopenia were the strongest risk factors for mortality in the multivariate analysis in the overall COPD population. Inhaled corticosteroid use was not associated to mortality.Conclusion: Hospitalizations for ECOPD without COVID-19 were more frequent than COPD with COVID-19 during the first outbreak, but the latter were associated with higher mortality and low eosinophil counts that warrant further analysis.Keywords: COPD exacerbation, mortality, inhaled corticosteroids, hospitalization

The concept of chronic obstructive pulmonary disease (COPD) control has been proposed to guide treatment decisions in COPD. In this study, we aimed to validate the prospective value of this concept in the SPARK study population. Control was assessed based on COPD stability and impact. Patients with low impact and stability during weeks 1–12 were classified as controlled, and exacerbations were measured during a 52-week follow-up. Of the 2044 patients included a majority were non-controlled (80%), frequently due to high impact. During the follow-up, the rate of moderate/severe exacerbations was significantly lower in controlled patients (rate ratio, 0.56, 95% CI 0.48 to 0.65 p

Resumen Objetivo Describir un acuerdo entre expertos basado en la evidencia y la experiencia sobre los aspectos mas relevantes del paciente exacerbador con EPOC. Metodos Se siguio la metodologia Delphi. Tras revisar la evidencia por un comite cientifico y 60 expertos, se elaboro un cuestionario con 3 apartados: diagnostico del paciente exacerbador; tratamiento, y proceso asistencial. La encuesta fue respondida online en 2 rondas por 60 neumologos. El grado de acuerdo siguio la escala Likert de 1 (total desacuerdo) a 9 (total acuerdo), definiendose acuerdo y desacuerdo como una puntuacion de 7-9 o 1-3, respectivamente, otorgada por mas de dos tercios de los participantes. Resultados Se incluyeron un total de 48 aseveraciones, una anadida en la segunda ronda. Hubo consenso en 37 (78,7%) tras la primera ronda (acuerdo), y en 43 (89,5%) tras la segunda (42 acuerdo y 1 desacuerdo). Las afirmaciones con mayor proporcion de expertos en el rango de acuerdo se refirieron a que, en el paciente exacerbador, la infeccion bronquial cronica favorece el deterioro de la funcion pulmonar (93,1%), a que no se deben retirar los broncodilatadores de larga duracion (93,1%), a la conveniencia de personalizar el tratamiento si se dan nuevas exacerbaciones pese a un tratamiento broncodilatador optimo (96,6%), o al cuidado y manejo de este paciente, que debe ser coordinado entre atencion primaria y neumologia (93,1%) y controlado en programas integrados especificos multicomponente (94,8%). Conclusiones La informacion proporcionada por este consenso puede facilitar el diagnostico y tratamiento del paciente exacerbador con EPOC en nuestro ambito.

We aimed to compare clinical characteristics between Asian and Western chronic obstructive pulmonary disease (COPD) patients. This was a sub-analysis of an international, multicenter, prospective cohort study. Asian patients were enrolled in Singapore and South Korea. Western patients were enrolled in Spain, Poland, Ireland, the United Kingdom, and Malta. A total of 349 patients were analyzed. Among them, 110 (32%) patients were Asian and 239 (68%) Western. Male sex was more predominant in Asian than in Western (95% versus 63%, respectively; P