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COPD is a leading cause of death and disability. COPD therapy goals include reducing exacerbations and improving symptom control. Single-inhaler triple therapy (SITT) or multiple-inhaler triple therapy (MITT) is indicated for patients with frequent exacerbations despite bronchodilator therapy. No available evidence compares SITT vs MITT in Spain in terms of treatment persistence, exacerbations, and other outcomes. Do COPD patients in Spain initiating SITT vs MITT have improved persistence, exacerbations, and health care resource utilization? This real-world, observational, retrospective cohort study analyzed electronic health records in the Spanish National Healthcare System BIG-PAC database to identify COPD patients aged ≥ 40 years initiating SITT or MITT (using two or three inhalers) between June 1, 2018 and December 31, 2019. Comparative data on persistence (allowing up to 60 days without prescription refill), exacerbation rates, and health care resource utilization and costs during 12-month follow-up were analyzed. Multivariate adjusted analyses were performed. Eligible patients (N = 4,625) initiating SITT (n = 1,011) or MITT (n = 3,614) had a mean age of 70.9 years; most were male (73.9%) with mainly moderate (62.0%) or severe (26.5%) airflow limitation. Between-cohort baseline characteristics were similar. At 12-month follow-up, SITT patients had higher persistence (hazard ratio [HR] = 1.37; 95% CI = 1.22-1.53; P Patients initiating SITT had a clinically relevant improvement in persistence leading to reductions in mortality, incidence of exacerbations, and health care resource use with consequent mean cost savings.

This study was funded by Chiesi.

Resumen: A pesar de la aparición de numerosas revisiones sistemáticas y metaanálisis sobre el uso de la doble terapia broncodilatadora para el tratamiento de la enfermedad pulmonar obstructiva crónica, la eficacia comparada de estas combinaciones entre sí no se ha explorado tan exhaustivamente. En la presente revisión narrativa se revisan los primeros estudios de doble terapia broncodilatadora y se evalúan los estudios que comparan dobles terapias broncodilatadoras en dispositivos por separado y en un único dispositivo. Los primeros ensayos de doble terapia en dispositivos separados se realizaron como una prueba de concepto sobre la función pulmonar con escaso tiempo de seguimiento o un número de pacientes reducido. Estos estudios mostraban mejorías no consistentes en función pulmonar, con escasa repercusión en síntomas u otros resultados clínicos. Los estudios que han comparado de forma directa la combinación de dos broncodilatadores de acción prolongada a dosis fijas en un único dispositivo han explorado principalmente las diferencias entre umeclidinio-vilanterol y diversas asociaciones. Estos trabajos muestran una mayor capacidad broncodilatadora de umeclidinio-vilanterol, con una reducción del uso de medicación de rescate. Por otro lado, no se observan diferencias aparentes en el control sintomático que ofrecen estas combinaciones entre sí y existen dudas sobre su impacto en la prevención de agudizaciones moderadas o graves. En el futuro sería interesante poder disponer de estudios que indiquen el efecto a largo plazo de estas combinaciones en el curso de la enfermedad, así como estudios encaminados a investigar los determinantes de las respuestas a estos fármacos tanto en función pulmonar como en síntomas, calidad de vida y exacerbaciones. Abstract: Despite the publication of numerous systematic reviews and meta-analyses on the use of dual bronchodilator therapy in the treatment of chronic obstructive pulmonary disease, the comparative efficacy of the different combinations has not been explored in depth. In this narrative review, we revisit the initial dual bronchodilator therapy studies and evaluate studies that compare dual bronchodilator therapies administered in separate devices and in a single device. The first trials on dual therapy delivered in separate devices were conducted as proof of concept studies, exploring lung function in limited patient numbers with short follow-up periods. These studies showed inconsistent improvements in lung function with little impact on symptoms or other clinical outcomes. Studies that directly compared fixed doses of long-acting bronchodilators in a single device investigated differences between umeclidinium/vilanterol and other combinations. These studies show increased bronchodilator capacity of umeclidinium/vilanterol with reduced use of rescue medication. However, no apparent differences were observed in the symptomatic control achieved by these different combinations, raising doubts about their impact on prevention in moderate or severe exacerbations. In the future, it would be interesting to see studies that analyze the long-term effect of these combinations on the disease course, as well as studies aimed at investigating the determinants of responses to these drugs in terms of lung function, symptoms, quality of life and exacerbations.

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.

Although the chronic presence of microorganisms in the airways of patients with stable chronic obstructive pulmonary disease (COPD) confers a poor outcome, no recommendations have been established in disease management guidelines on how to diagnose and treat these cases. In order to guide professionals, the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) has prepared a document which aims to answer questions on the clinical management of COPD patients in whom microorganisms are occasionally or habitually isolated. Since the available scientific evidence is too heterogeneous to use in the creation of a clinical practice guideline, we have drawn up a document based on existing scientific literature and clinical experience, addressing the definition of different clinical situations and their diagnosis and management. The text was drawn up by consensus and approved by a large group of respiratory medicine experts with extensive clinical and scientific experience in the field, and has been endorsed by the SEPAR Scientific Committee.

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

Introduction Despite the evidence provided by clinical trials, there are some uncertainties and controversies regarding the use of triple inhaled therapy. With the aim of evaluating clinical practice in specialized respiratory units, a Delphi consensus document was implemented on the use of single-inhaler fixed-dose triple therapies after 1 year of use in Spain. Methods A scientific committee of COPD experts defined a thematic index, guided a systematic literature review and helped design the Delphi questionnaire. This was sent to the other 45 COPD experts between April and June 2019. Agreement/disagreement on 58 statements was tested in two rounds using a Likert scale. Replies were classified as a consensus when ≥80% of the panelists agreed; a majority when a degree of agreement of ≥66% was reached; and divergence if agreement was Results After two rounds, 44.44% of the statements reached consensus, 14.81% reached majority and 40.74% were divergent. Panelists agreed that escalating from double bronchodilation should be phenotype-based and aim to prevent exacerbations but not for improving symptoms. The addition of an antimuscarinic to inhaled corticosteroids combinations achieves improvement in lung function, symptoms and exacerbation prevention. Main safety concerns included the increased risk of pneumonia as compared to bronchodilator therapies, with similar cardiovascular effects. There was no consensus agreement on patient type response based on blood eosinophil counts or obstruction severity. Conclusion The low degree of consensus among panelists may reflect the complexity of severe COPD management. The information provided here may be useful to clinicians implementing personalized medicine for COPD patients.

[ES] La aparición de la denominada triple terapia inhalada mediante la combinación de un agonista β2 de acción prolongada (LABA), un anticolinérgico de acción prolongada (LAMA) y un corticoide inhalado (ICS) en una combinación a dosis fijas (CDF) en un solo dispositivo de inhalación ha supuesto un cambio en el uso de este tratamiento. A pesar de que los ensayos clínicos nos aportan una idea de la eficacia y la seguridad de estas CDF, su aplicación a la clínica diaria puede presentar retos para el clínico sobre dos escenarios concretos. En pacientes que ya están recibiendo una triple terapia en dispositivos distintos el cambio a una CDF podría suponer beneficios en cuanto a disminución de errores críticos en el manejo de los inhaladores, mayor adherencia al tratamiento y menor coste, manteniendo la misma eficacia clínica. En pacientes que no están recibiendo una triple terapia en dispositivos distintos y que necesiten un cambio en el tratamiento, la CDF de triple terapia presenta beneficios mostrados en los ensayos clínicos. Aunque las diferencias metodológicas entre ensayos desaconsejan comparaciones directas, los resultados clínicos muestran una buena eficacia, pero también una considerable variabilidad y un número de resultados clínicos aún por explorar. En el futuro deberán desarrollarse ensayos que completen los datos de eficacia clínica, estudios en vida real que informen de su efectividad y trabajos encaminados a descubrir el perfil de paciente que presenta una mayor respuesta terapéutica a cada CDF, con el objeto de avanzar en el tratamiento personalizado., [EN] The emergence of a fixed-dose combination (FDC) of a long-acting β2-agonists (LABAS), a long-acting anticholinergic agent (LAMA), and an inhaled corticosteroid (ICS) in a single inhalation device has changed the approach to inhaled therapy. Although clinical trials describe the efficacy and safety of these FDCs, their use in daily clinical practice can present challenges for the clinician in two specific scenarios. In patients who are already receiving triple therapy via different devices, switching to FDCs could confer benefits by reducing critical errors in the management of inhalers, improving therapeutic adherence, and lowering costs, while maintaining the same clinical efficacy. In patients who are not receiving triple therapy in different devices and who require a change in treatment, triple therapy FDC has shown benefits in clinical trials. Although methodological differences among the trials advise against direct comparison, clinical results show good efficacy, but also considerable variability, and a number of clinical outcomes have yet to be explored. In the future, trials must be developed to complete clinical efficacy data. Real-world efficacy trials are needed, and studies must be designed to determine the profile of patients who present a greater therapeutic response to each FDC in order to pave to way towards more personalized treatment.

Resumen: La oxigenoterapia crónica domiciliaria (OCD) consiste en el uso terapéutico del oxígeno a concentraciones mayores de las que se encuentran en el aire ambiente, con la intención de tratar o prevenir las manifestaciones a largo plazo de la hipoxia. Esta terapia ha demostrado aumentar la supervivencia en los enfermos con enfermedad pulmonar obstructiva crónica (EPOC) e insuficiencia respiratoria crónica (IRC). Este concepto se ha extendido por analogía a la IRC originada por otras enfermedades respiratorias y no respiratorias, sin que su efectividad haya podido ser demostrada. La OCD no se ha demostrado efectiva en mejorar la supervivencia de pacientes con EPOC e hipoxemia moderada. Tampoco hay consenso sobre su empleo durante las desaturaciones nocturnas en EPOC y durante las desaturaciones al esfuerzo. La OCD actual debe valorar la situación clínica y social, adecuando las fuentes de administración de oxígeno al perfil de movilidad de los pacientes, conseguir la adecuada selección de paciente y fuente de oxígeno y es imprescindible titular la oxigenoterapia para asegurar la corrección de la hipoxemia. La búsqueda del equipo de oxígeno ideal, mejorar los sistemas de regulación e información de las terapias, avanzar en la educación de los pacientes y potenciar la investigación, son líneas de trabajo que nos marcan el futuro de la OCD. Abstract: Continuous home oxygen therapy (HOT) is the therapeutic use of oxygen at higher concentrations than those found in ambient air for treating or preventing long-term manifestations of hypoxia, and has been shown to increase survival in patients with chronic obstructive pulmonary disease (COPD) and chronic respiratory failure (CRF). This concept has been extended by analogy to CRF originating from other respiratory and non-respiratory diseases, but its effectiveness has not been demonstrated. HOT has not been shown to be effective in improving the survival of patients with COPD and moderate hypoxemia, nor is there any consensus on its use during nocturnal desaturations in COPD and desaturations caused by exertion. In the current use of HOT, the patient's clinical and social situation should be assessed, oxygen supply sources must be adapted to the patient's mobility profile, the appropriate oxygen source must be selected for each patient, and oxygen therapy must be titrated to ensure that hypoxemia is corrected. Lines of research that will shape the future of HOT include investigating the ideal equipment, improving regulation systems and information about treatments, educating patients, and promoting research.

The aim of this report is to review the literature and shed light on the uncertainties surrounding the use of antiviral agents in general and remdesivir in COVID-19 patients. This review evaluated a battery of antiviral compounds and their effectiveness in the treatment of COVID-19 since the beginning of the pandemic. Remdesivir is the only antiviral approved by the EMA and FDA for the treatment of SARS-CoV-2 infection. This work extensively reviews remdesivir data generated from clinical trials and observational studies, paying attention to the most recent data, and focusing on outcomes to give readers a more comprehensive understanding of the results. This review also discusses the recommendations issued by official bodies during the pandemic in the light of the current knowledge. The use of remdesivir in the treatment of SARS-CoV-2 infection is justified because a virus is the causative agent that triggers the inflammatory responses and its consequences. More trials are needed to improve the management of this disease.

In recent years, personalized or precision medicine has made effective inroads into the management of diseases, including respiratory diseases. The route to implementing this approach must invariably start with the identification and validation of biological biomarkers that are closely related to the diagnosis, treatment, and prognosis of respiratory patients. In this respect, biological biomarkers of greater or lesser reliability have been identified for most respiratory diseases and disease classes, and a large number of studies are being conducted in the search for new indicators. The aim of this review is to update the reader and to analyze the existing scientific literature on the existence and diagnostic, therapeutic, and prognostic validity of the most important biological biomarkers in the main respiratory diseases, and to identify future challenges in this area.

Introduction: Type 2 (T2) biomarkers such as blood eosinophil count (BEC) and FeNO have been related to a higher risk of exacerbations in COPD. It is unknown whether combining these biomarkers could be useful in forecasting COPD exacerbations Methods: COPD patients were enrolled in this propspective, multicenter, observational study and followed up for 1 year, during which BEC were analised at baseline (V0) while FeNO analyses were performed at baseline (V0), 6 months (V1) and 12 months (V2). The risk of moderate or severe exacerbation during follow up was assessed by Cox regression analysis, and the predictive capacity of both measurements was assessed by ROC curves and the DeLong test. Statistical significance was assumed at p Results: Of the 322 COPD patients initially recruited, 287 were followed up. At baseline, 28.0% were active smokers, and experienced moderate airflow limitation (mean FEV1 56.4 ±17.0% predicted). Patients with at least one elevated T2 biomarker (n=125, 42.5%) were at increased risk of COPD exacerbation (HR 1.75, 95% CI 1.25-2.45, p=0.001) and of shorter time to first COPD exacerbation. There was no difference between BEC and FeNO regarding the predictive capacity for moderate to severe exacerbation (AUC 0.584 vs 0.576, p=0.183) but FeNO predicted severe episodes more accurately than BEC (AUC 0.607 vs 0.539, p Conclusions: Both eosinophil count and FeNO have limited utility for predicting COPD exacerbations. Combining these T2 biomarkers could enhance the detection of future COPD exacerbations.

Aim This cross-sectional multicenter study was performed aimed at describing the clinical characteristics of women with COPD attended in routine daily practice in Spain. Methods and results Of a total of 1610 consecutive patients diagnosed with COPD recruited in primary care centers and pneumology services throughout Spain over a 90-day period, 17.9% (n=286) were women, with a median age of 62 years. Differences in COPD phenotypes by sex were statistically significant (P = 0.002). Males as compared with females showed a higher prevalence of non-exacerbator (47.9% vs 42.2%) and exacerbator with chronic bronchitis (22.9% vs 18.8%) phenotypes, whereas the ACOS phenotype was more common among females (21.7% vs 12.9%). The mean (SD) CAT score was similar in men than in women (20.8 [9.0] vs 21.2 [8.7], P = 0.481), as well as the impact of the disease on the quality of life according to CAT scores of 20 (high), and >30 (very high). Sex-related differences according to smoking status were statistically significant (P < 0.001), with a higher percentage of men as compared with women in the groups of current smokers and ex-smokers; never-smokers were higher in women (9.1%) than in men (0.6%). The mean number of comorbidities was 2.01 (1.43) (95% CI 1.93-2.09) in males and 1.99 (1.42) (95% CI 1.83-2.16) (P = 0.930) in females, but cardiovascular diseases (hypertension, ischemic heart disease, chronic heart failure) were more frequent in men, whereas metabolic disorders (osteoporosis) were more frequent in women. Conclusion This study highlights the impact of COPD in women and the importance of continuing sex-based research in tobacco-related respiratory diseases.

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.

Bernardino Alcázar-Navarrete,1,2 Francisco García-Rio,2,3 Guadalupe Sánchez,4 Esther Mariscal,5 Andrea García,5 Maribel Cuesta,6 Estefany Uría,6 Marc Miravitlles2,7 1Respiratory Department. Hospital Universitario Virgen de las Nieves, Granada, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain; 3Hospital Universitario La Paz, IdiPAZ, Madrid, Spain; 4Medical Department, GSK, Madrid, Spain; 5Market Access Department, GSK, Madrid, Spain; 6Oblikue Consulting, Barcelona, Spain; 7Pneumology Department, Hospital Universitari Vall d’Hebron, Vall D’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainCorrespondence: Francisco García-RioHospital Universitario La Paz, Idipaz, Paseo de la Castellana, 261, Madrid, 28046, SpainTel +34 917 27 70 00Email fgr01m@gmail.comBackground: The cost of chronic obstructive pulmonary disease (COPD) in Spain has been studied from different perspectives, but parameters such as the patient’s phenotype have seldom been considered. Our aim was to describe the disease burden of COPD patients with frequent exacerbator phenotype, treated with triple therapy.Methods: An observational, multicenter study was carried out from December 2017 to November 2018 in pulmonology services among patients ≥ 40 years with COPD confirmed diagnosis receiving triple therapy (ICS/LAMA/LABA) and history of ≥ 2 moderate or ≥ 1 severe exacerbation in the 12 months prior to the inclusion visit. COPD-related healthcare resources were collected over a 12-months period prior to the inclusion visit: pharmacological and non-pharmacological treatments, medical and ER visits, hospitalizations, tests and productivity loss. Costs were updated to € 2019. Patients were classified according to blood eosinophil levels: < 150 cells/μL and ≥ 150 cells/μL.Results: A total of 306 patients were included (77.1% men), with mean age of 69.9 years. Mean COPD exacerbation rate was 2.5/patient/year and 51.3% of patients had ≥ 150 cells/μL eosinophil level. On average, for the total population, COPD-related visits/patients/year were 6.2. Resource use in moderate exacerbation was higher in patients with eosinophils ≥ 150 cells/μL, whereas in severe exacerbation was higher in patients with eosinophils < 150cells/μL. According to eosinophil levels, total annual mean (SD) costs/patient accounted for € 8382 (9863) and € 5144 (5444) for patients with eosinophils < 150 cells/μL and ≥ 150 cells/μL, respectively.Conclusion: The impact of exacerbating COPD patients treated with triple therapy in Spain is large, especially among those with eosinophils < 150 cells/μL.Keywords: frequent exacerbation, triple therapy, cost, eosinophil, health care resources, COPD

Objective There is controversy regarding the significance of radiological consolidation in the context of COPD exacerbation (eCOPD). While some studies into eCOPD exclude these cases, consolidation is a common feature of eCOPD admissions in real practice. This study aims to address the question of whether consolidation in eCOPD is a distinct clinical phenotype with implications for management decisions and outcomes. Patients and Methods The European COPD Audit was carried out in 384 hospitals from 13 European countries between 2010 and 2011 to analyze guideline adherence in eCOPD. In this analysis, admissions were split according to the presence or not of consolidation on the admission chest radiograph. Groups were compared in terms of clinical and epidemiological features, existing treatment, clinical care utilized and mortality. Results 14,111 cases were included comprising 2,714 (19.2%) with consolidation and 11,397 (80.8%) without. The risk of radiographic consolidation increased with age, female gender, cardiovascular diseases, having had two or more admissions in the previous year, and sputum color change. Previous treatment with inhaled steroids was not associated. Patients with radiographic consolidation were significantly more likely to receive antibiotics, oxygen and non-invasive ventilation during the admission and had a lower survival from admission to 90-day follow-up. Conclusions Patients admitted for COPD exacerbation who have radiological consolidation have a more severe illness course, are treated more intensively by clinicians and have a poorer prognosis. We recommend that these patients be considered a distinct subset in COPD exacerbation.

Sin financiación 4.872 JCR (2020) Q2, 18/64 Respiratory System 0.262 SJR (2021) Q3, 102/144 Pulmonary and Respiratory Medicine No data IDR 2020 UEM

BACKGROUND Hospital workers have been the most frequently and severely affected professional group during the COVID-19 pandemic, and have a big impact on transmission. In this context, innovative tools are required to measure the symptoms compatible with COVID-19, the spread of infection, and testing capabilities within hospitals in real time. OBJECTIVE We aimed to develop and test an effective and user-friendly tool to identify and track symptoms compatible with COVID-19 in hospital workers. METHODS We developed and pilot tested Hospital Epidemics Tracker (HEpiTracker), a newly designed app to track the spread of COVID-19 among hospital workers. Hospital staff in 9 hospital centers across 5 Spanish regions (Andalusia, Balearics, Catalonia, Galicia, and Madrid) were invited to download the app on their phones and to register their daily body temperature, COVID-19–compatible symptoms, and general health score, as well as any polymerase chain reaction and serological test results. RESULTS A total of 477 hospital staff participated in the study between April 8 and June 2, 2020. Of note, both health-related (n=329) and non–health-related (n=148) professionals participated in the study; over two-thirds of participants (68.8%) were health workers (43.4% physicians and 25.4% nurses), while the proportion of non–health-related workers by center ranged from 40% to 85%. Most participants were female (n=323, 67.5%), with a mean age of 45.4 years (SD 10.6). Regarding smoking habits, 13.0% and 34.2% of participants were current or former smokers, respectively. The daily reporting of symptoms was highly variable across participating hospitals; although we observed a decline in adherence after an initial participation peak in some hospitals, other sites were characterized by low participation rates throughout the study period. CONCLUSIONS HEpiTracker is an already available tool to monitor COVID-19 and other infectious diseases in hospital workers. This tool has already been tested in real conditions. HEpiTracker is available in Spanish, Portuguese, and English. It has the potential to become a customized asset to be used in future COVID-19 pandemic waves and other environments. CLINICALTRIAL ClinicalTrials.gov NCT04326400; https://clinicaltrials.gov/ct2/show/NCT04326400

Background: A head-to-head study demonstrated the superiority of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg on trough forced expiratory volume in 1 s (FEV1) versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated the cost effectiveness of UMEC/VI versus TIO/OLO from a Spanish National Healthcare System perspective, using data from this study and Spanish literature. Methods: This analysis was conducted from the perspective of the Spanish National Healthcare System with a 3-year horizon as base case. A disease progression model using a linked risk equation approach was used to estimate disease progression and associated healthcare costs, and quality-adjusted life years (QALYs). The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was used to develop the statistical risk equations for clinical endpoints, and costs were calculated using a health state approach (by dyspnea severity). Utilities for QALY calculation were estimated using patient baseline characteristics within a regression fit to Spanish observational data. Treatment effect, expressed as change from baseline in FEV1 was obtained from the head-to-head study and used in the model (UMEC/VI minus TIO/OLO difference: + 52 mL [95% confidence interval: 28, 77]). Baseline patient characteristics were sourced from Spanish literature or the head-to-head study if unavailable. A scenario analysis using only the intent-to-treat (ITT) population from the head-to-head study, and sensitivity analyses (including probabilistic sensitivity analyses), were conducted. Direct healthcare costs (2017 Euro) were obtained from Spanish sources and costs and benefits were discounted at 3% per annum. Results: UMEC/VI was associated with small improvements in QALYs (+ 0.029) over a 3-year time horizon, compared with TIO/OLO, alongside cost savings of €393/patient. The ITT scenario analysis and sensitivity analyses had similar results. All probabilistic simulations resulted in UMEC/VI being less costly and more effective than TIO/OLO. Conclusion: UMEC/VI dominated TIO/OLO (more effective and less expensive). These results may aid payers and decision-makers in Spain when making judgements on which long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) treatments can be considered cost effective in Spain., This study was funded by GSK (study number HO-17-17500). The funders of the study had a role in study design, data analysis, data interpretation, and writing of the report. Data analysis was conducted by ICON Health Economics and funded by GSK. No funding was provided to employees of ICON Health Economics for manuscript development

Introduction Exhaled nitric oxide (FENO) measurements differentiate COPD phenotypes from asthma–COPD overlap (ACO). To date, no study has been conducted to determine whether alveolar and bronchial components differ in this group of patients. Methods This was an observational cross-sectional study recruiting ambulatory COPD patients. FENO was measured, differentiating alveolar (CANO) from bronchial (JawNO) components using a multiple-flow technique. CANO and JawNO values were compared between eosinophilic COPD patients (defined as ≥300 eosinophils/μL in peripheral blood test, or ≥2% eosinophils or ≥3% eosinophils), and a linear regression analysis was performed to determine clinical and biological variables related to these measurements. Results 73 COPD patients were included in the study. Eosinophil counts were associated with increased values of CANO and JawNO (for the latter only the association with ≥300 or ≥3% eosinophils was significant). CANO was also associated with CRP, and JawNO with smoking. Conclusions Patients with COPD and ACO characteristics show increased inflammation in the large and small airways. CANO and JawNO are associated with clinical and biological variables.

Resumen Introduccion La medicion del oxido nitrico en el aire exhalado diferencia fenotipos de pacientes con EPOC del solapamiento de asma y EPOC (ACO). Hasta el momento no se ha estudiado si existen diferencias entre los componentes alveolar y bronquial del FENO en este grupo de pacientes. Metodos Estudio observacional transversal realizado en consultas externas de Neumologia, incluyendo a pacientes con diagnostico de EPOC a los que se les realizo una determinacion del oxido nitrico en aire exhalado – FENO– diferenciando en esta medida el componente alveolar –CANO– y el de via aerea central –JawNO–, y realizando las mediciones a distintos flujos. Se compararon los valores de CANO y JawNO entre los pacientes con eosinofilia (definidos como aquellos pacientes con ≥ 300 eosinofilos/ μL en sangre periferica, o bien ≥ 2% eosinofilos o ≥ 3% eosinofilos) y se realizo un analisis de regresion lineal para estudiar las variables clinicas y biologicas que se asociaban a estas mediciones. Resultados Participaron en el estudio 73 pacientes con EPOC. Los criterios de eosinofilia utilizados se asociaban a incrementos de los valores de CANO y de JawNO (en este ultimo caso solo los criterios ≥ 300 eosinofilos y ≥ 3% eosinofilos). CANO se asocio al recuento de eosinofilos y PCR, y JawNO se asocio a tabaquismo y recuento de eosinofilos. Conclusiones Los pacientes diagnosticados de EPOC y que tienen caracteristicas de ACO muestran mayor inflamacion a nivel bronquial y de via aerea pequena. CANO y JawNO se relacionan con variables clinicas y biologicas.

Introduction Appropriate timing for dual bronchodilator therapy initiation in chronic obstructive pulmonary disease (COPD) management is uncertain. Combination therapy is recommended as step-up from monotherapy or first-line treatment in patients with persistent symptoms. In this setting, umeclidinium/vilanterol (UMEC/VI) demonstrated improved lung function and reduced rescue medication use over tiotropium/olodaterol (TIO/OLO). This subgroup analysis explored efficacy differences between these combinations in patients naïve to COPD maintenance therapy before study entry. Methods Post hoc analysis of an 8-week, randomized, open-label, assessor-blind, two-period crossover study (204990; NCT02799784) comparing UMEC/VI 62.5/25 mcg and TIO/OLO 5/5 mcg, focused on maintenance-naïve (MN) patients with moderate COPD and persistent symptoms (modified Medical Research Council dyspnea score ≥ 2). Change from baseline (CFB) in trough forced expiratory volume in 1 s (FEV1), percentage of FEV1 responders (CFB ≥ 100 ml), rescue medication use and safety were evaluated. Results The MN population comprised 63% of the intent-to-treat (ITT) population (148/236 patients) and had similar baseline demographics. At week 8, adjusted mean (standard error) improvements in trough FEV1 from baseline were clinically meaningful for both combinations (UMEC/VI: 167 [17] ml; TIO/OLO 110 [18] ml; adjusted mean difference [95% confidence interval (CI)]: 57 [23–92] ml; p = 0.001; %CFB: 11 vs. 8%). Proportion of FEV1 responders was greater with UMEC/VI versus TIO/OLO at week 8 (60 vs. 42%; odds ratio [95% CI] 1.90 [1.12–3.22]; p = 0.018). Reduction in rescue medication use was 0.20 (95% CI 0.07–0.34) puffs/day greater with UMEC/VI versus TIO/OLO over weeks 1–8 (p = 0.003). Adverse events incidence was similar (UMEC/VI: 24%; TIO/OLO: 29%). Conclusions These results highlight that the efficacy difference between UMEC/VI and TIO/OLO demonstrated in the ITT population is maintained in MN patients. Greater lung function improvements with UMEC/VI versus TIO/OLO were accompanied by symptom improvements, as reflected in a significantly lower need for supplemental rescue medication. Funding GSK. Trial registration NCT02799784

Resumen Introduccion EPOCONSUL es la primera auditoria nacional que analiza la atencion sanitaria de la EPOC en consultas de neumologia en Espana. El objetivo principal fue determinar, en un analisis retrospectivo, la distribucion de los niveles de riesgo de la EPOC segun GesEPOC 2017 y evaluar las actuaciones clinicas segun las nuevas recomendaciones. Material y metodos Es una auditoria clinica de diseno trasversal, con reclutamiento de casos consecutivos de EPOC durante un ano. Se evaluo el nivel de riesgo y el fenotipo clinico segun GesEPOC 2017 y su relacion con las intervenciones clinicas realizadas. Resultados El nivel de alto riesgo fue mas frecuente (79,8 versus 20,2%; p Conclusiones La mayoria de los pacientes atendidos en las consultas de neumologia fueron de alto riesgo y con fenotipo clinico no agudizador. La practica clinica realizada fue diferente segun el nivel de riesgo y mayoritariamente acorde con las recomendaciones de GesEPOC, aunque con importantes areas de mejora.

Chronic obstructive pulmonary disease is progressive and in its advanced stage is associated with major disability. Previous studies suggest that patients with this disease receive little palliative care, even in very advanced stages. Given this, our objectives were to describe the clinical practice of Spanish pulmonologists in the care of patients with end-stage chronic obstructive pulmonary disease, to identify potential barriers to implementing palliative care in these patients and to correlate these responses with doctor's years of experience. A link to an online survey was sent to pulmonologists on (a) symptom management, (b) structure of their department and collaboration with other services, (c) specialized medical training in palliative care, (d) communication with patients and their families, and (e) limiting barriers identified in the management of these patients. A total of 387 responses were received. The majority used opioids to treat dyspnea (52.9%) or pain (54.2%) and many treated anxiety/depression (41%). Around half of the respondents had no established routines in their departments to offer palliative care to patients with chronic obstructive pulmonary disease. There was little communication with end-of-life patients and their families on disease course, mainly associated with a lack of medical training (83% of cases) and changes in patient wishes regarding care through the disease course (81%). In our setting, communication with end-of-life patients with chronic obstructive pulmonary disease is poor. The key challenges identified are insufficient medical training and changing desires of patients. No substantial differences in attitude were found as a function of experience.

Sin financiación 4.872 JCR (2020) Q2, 18/64 Respiratory System 0.262 SJR (2021) Q3, 102/144 Pulmonary and Respiratory Medicine No data IDR 2020 UEM

Introduction We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD. Methods This was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age 40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1) of 70% or less and 50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled corticosteroid therapy. Patients were randomized to receive UMEC/VI (62.5/25 µg once daily) via a multidose dry powder inhaler (ELLIPTA) followed by TIO/OLO (5/5 µg once daily) via a soft mist inhaler (Respimat), each for 8 weeks with an interim 3-week washout or vice versa. The primary end point was the change from baseline in trough FEV1 at week 8 with a noninferiority margin of − 50 mL in the per-protocol (PP) population. The incidence of adverse events was also assessed. Results In total, 236 patients (mean age 64.4 years, 60% male) were included in the intent-to-treat population and 227 were included in the PP population. UMEC/VI treatment was noninferior in the PP population and superior in the intent-to-treat population to TIO/OLO treatment with regard to trough FEV1 at week 8 [FEV1 change from baseline 180 mL vs 128 mL; difference 52 mL (95% confidence interval 28–77 mL); p