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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

Juan Antonio Trigueros,1 Juan Antonio Riesco,2,3 Bernardino Alcázar-Navarrete,3,4 Anna Campuzano,5 Joselín Pérez5 1Centro de Salud de Menasalbas, Menasalbas, Toledo E-45128, Spain; 2Pulmonology Department, Hospital San Pedro de Alcántara, Cáceres E-10003, Spain; 3Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Cáceres, Spain; 4Pulmonology Department, Hospital de Alta Resolución La Loja, Loja, Granada E-18300, Spain; 5Grupo Ferrer Internacional, Barcelona, SpainCorrespondence: Juan Antonio Trigueros Tel +34 686 329 851Email triguexx57@gmail.comAim: 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.Keywords: pulmonary disease, chronic obstructive, chronic bronchitis, phenotype, pulmonary emphysema, quality of life, asthma

Bernardino Alcázar-Navarrete,1 Juan Antonio Trigueros,2 Juan Antonio Riesco,3,4 Anna Campuzano,5 Joselín Pérez5 1Pulmonology Department, Hospital La Loja, Granada, 2Centro de Salud de Menasalvas, Toledo, 3Pulmonology Department, Hospital San Pedro de Alcántara, 4Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Cáceres, 5Grupo Ferrer Internacional, Barcelona, Spain Purpose: The purpose of this study was to assess the prevalence of COPD phenotypes at a national level and to determine their geographic distribution among different autonomous communities in Spain. Patients and methods: A total of 1,610 patients (82% men, median age 67 years) recruited in primary care centers and pneumology services participated in an observational, cross-sectional, and multicenter study. Phenotypes evaluated were the non-exacerbator phenotype, the asthma–COPD overlap syndrome (ACOS), the exacerbator phenotype with emphysema, and the exacerbator phenotype with chronic bronchitis. Results: The non-exacerbator phenotype was the most common (46.7%) followed by exacerbator with chronic bronchitis (22.4%) and exacerbator with emphysema (16.4%). The ACOS phenotype accounted for the lowest rate (14.5%). For each phenotype, the highest prevalence rates were concentrated in two or three autonomous communities, with relatively similar rates for the remaining regions. Overall prevalence rates were higher for the non-exacerbator and the exacerbator with chronic bronchitis phenotypes than for ACOS and the exacerbator with chronic bronchitis phenotypes. Differences in the distribution of COPD phenotypes according to gender, age, physician specialty, smoking habit, number of comorbidities, quality of life assessed with the COPD Assessment Test, and BODEx index (body mass index, airflow obstruction, dyspnea, and exacerbations) were all statistically significant. Conclusion: Differences in the prevalence rates of COPD phenotypes among the Spanish autonomous communities have been documented. Mapping the distribution of COPD phenotypes is useful to highlight regional differences as starting point for comparisons across time. This geographic analysis provides health-care planners a valuable platform to assess changes in COPD burden at nationwide and regional levels. Keywords: pulmonary disease, chronic obstructive, phenotype, quality of life

Juan José Soler-Cataluña,1,2 Bernardino Alcázar-Navarrete,3 Marc Miravitlles2,4 1Pneumology Department, Hospital Arnau de Vilanova, Valencia, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), 3Respiratory Department, Hospital de Alta Resolucion, Granada, Spain; 4Pneumology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain Abstract: Treatment of chronic obstructive pulmonary disease (COPD) requires a personalized approach according to the clinical characteristics of the patients, the level of severity, and the response to the different therapies. Furthermore, patients with the same level of severity measured by the degree of airflow obstruction or even with multidimensional indices may have very different symptoms and limitations for daily activities. The concept of control has been extensively developed in asthma but has not been defined in COPD. Here, we propose a definition of COPD control based on the concepts of impact and stability. Impact is a cross-sectional concept that can be measured by questionnaires such as the COPD Assessment Test or the Clinical COPD Questionnaire. Alternatively, impact can be assessed by the degree of dyspnea, the use of rescue medication, the level of physical activity, and sputum color. Stability is a longitudinal concept that requires the absence of exacerbations and deterioration in the aforementioned variables or in the COPD Assessment Test or Clinical COPD Questionnaire scores. Control is defined by low impact (adjusted for severity) and stability. The concept of control in COPD can be useful in the decision making regarding an increase or decrease in medication in the stable state. Keywords: COPD, control, CAT, CCQ, exacerbations, prognosis

Miguel Turégano-Yedro,1 Eva Trillo-Calvo,2 Fernando Navarro i Ros,3,4 José David Maya-Viejo,5 Cruz González Villaescusa,6,7 Jose Maria Echave Sustaeta,8 Esperanza Doña,9 Bernardino Alcázar Navarrete10,11 1Centro de Salud Casar de Cáceres, Casar de Cáceres, Cáceres, Spain; 2Centro de Salud Campo de Belchite, Belchite, Zaragoza, Spain; 3Centro de Salud Ingeniero J Benlloch, Valencia, Spain; 4Red Investigadores SEMERGEN, Madrid, Spain; 5Unidad de Gestión Clínica de Camas, Distrito Sanitario Aljarafe-Sevilla Norte, Camas, Sevilla, Spain; 6Servicio de Neumología, Hospital Clínico Universitario de Valencia, Valencia, Spain; 7Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain; 8Servicio de Neumología, Hospital Universitario Quironsalud, Universidad Europea de Madrid, Madrid, Spain; 9Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Regional Universitario de Málaga, Málaga, Spain; 10Servicio de Neumología, Hospital Universitario Virgen de las Nieves, Granada, Spain; 11Instituto de Investigación Biosanitaria, Ibs- Granada, Granada, SpainCorrespondence: Miguel Turégano-Yedro, Centro de Salud Casar de Cáceres, Casar de Cáceres, C/ Barrionuevo Bajo, 49, Casar de Cáceres, Cáceres, 10190, Spain, Tel +34-927291531, Email tureyedro@gmail.comAbstract: COPD is a typical example of chronic disease. As such, treatment adherence tends to be as low as between 30% and 50%, with specific issues in COPD due to the use of inhaled therapies. Decreased adherence in COPD is associated with worse outcomes, with increased risk for exacerbations and long-term mortality. Factors that impact adherence are multiple, some related to patient, some related to clinicians and finally some related to healthcare system. Among clinician factors, prescription of simplified treatment regimens delivered by an inhaler adapted to the patient’s characteristics is crucial. Although it has been observed a huge improvement in the design and usability of inhaler devices for COPD in the last two centuries, there is still a clear gap in this field. Smart inhalers as well as simplified treatment regimens could improve adherence and therefore improve long-term outcomes in COPD.Plain Language Summary: Treatment adherence in COPD is crucial as in many other chronic diseases, with specific issues due to inhaled route, and many factors involved. Low adherence in COPD has been linked to an increased risk of exacerbations and future mortality. Many interventions have been developed to improve treatment adherence in COPD. This review summarizes the current knowledge and future prospects for this important aspect of COPD treatment.Keywords: COPD, inhaled therapies, adherence, persistence, posology

Bernardino Alcazar-Navarrete,1,2 Antonia Fuster,3 Patricia García Sidro,4 Juan Luis García Rivero,5 Beatriz Abascal-Bolado,6 Abel Pallarés-Sanmartín,7 Eduardo Márquez,2,8 Agustin Valido-Morales,9 Ana Boldova Loscertales,10 Francisco Javier Callejas-Gonzalez,11 Marta Palop,12 Juan Antonio Riesco,2,13 Rafael Golpe,14 Juan Jose Soler-Cataluña,2,15 Marc Miravitlles2,16 1AIG De Medicina. Hospital De Alta Resolución De Loja. Agencia Sanitaria Hospital De Poniente, Loja, Granada, Spain; 2CIBERES. Instituto De Salud Carlos III, Madrid, Spain; 3Servicio De Neumología. Hospital Universitario De Son Llatzer, Palma De Mallorca, Spain; 4Servicio De Neumología. Hospital De La Plana, Castellón, Spain; 5Servicio De Neumología. Hospital De Laredo, Laredo, Spain; 6Servicio De Neumología. Hospital Universitario Marqués De Valdecilla, Santander, Spain; 7Servicio De Neumología. Hospital Universitario Alvaro Cunqueiro, Vigo, Spain; 8Unidad Médico-Quirúrgica De Enfermedades Respiratorias. Hospital Virgen Del Rocío, Sevilla, Spain; 9UGC De Neumología. HU Virgen Macarena, Sevilla, Spain; 10Servicio De Neumología. Hospital Royo Villanova, Zaragoza, Spain; 11Servicio De Neumología. Complejo Hospitalario Universitario De Albacete, Albacete, Spain; 12Servicio De Neumología. Hospital De Sagunto, Sagunto, Spain; 13Servicio De Neumología. Hospital San Pedro De Alcántara, Cáceres, Spain; 14Servicio De Neumología. Hospital Universitario Lucus Augusti, Lugo, Spain; 15Servicio De Neumología. Hospital Arnau De Villanova- Lliria, Valencia, Spain; 16Servicio De Neumología. Hospital Universitari Vall De Hebron/Vall d’Hebron Institut De Recerca, Barcelona, SpainCorrespondence: Bernardino Alcazar-NavarreteHospital De Alta Resolución De Loja. Agencia Sanitaria Hospital De Poniente. Avda Tierno Galván s/n, Loja 18300, Granada, SpainEmail balcazar@telefonica.netBackground: 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< 0.005 for all comparisons) and to clinical criteria (mean differences of − 3.3, − 5-6 and − 4.99 units, respectively, p< 0.005 for all comparisons). The controlled patients also presented a significantly better HRQoL, measured by the EQ5D questionnaire (mean difference 0.13 and 0.10 at V2 by CAT or clinical criteria, respectively, p< 0.05).Conclusion: Clinical control in patients with COPD, whether measured by CAT or by clinical criteria, is associated with a lower symptom load and a better HRQoL.Keywords: control, symptoms, quality of life, impact, COPD

José Luis López-Campos,1,2 Bernardino Alcázar Navarrete,3 Juan Antonio Riesco Miranda,2,4 Borja G Cosío,2,5 Juan P de-Torres,6 Bartolomé Celli,7 Carlos A Jiménez-Ruiz,8 Ciro Casanova Macario9 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Sevilla, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; 3Hospital de Loja, Loja, Granada, Spain; 4Hospital Universitario de Cáceres, Cáceres, Spain; 5Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain; 6Respirology Division, Queen’s University, Kingston, ON, Canada; 7Brigham and Women’s Hospital, Harvard Medical School Boston, Boston, MA, USA; 8Unidad Especializada en Tabaquismo, Hospital Clínico San Carlos, Madrid, Spain; 9Servicio de Neumología-Unidad de Investigación, Hospital Universitario La Candelaria, Universidad de La Laguna, La Laguna, SpainCorrespondence: José Luis López-CamposHospital Universitario Virgen del Rocio, Avda. Manuel Siurot, S/N, Sevilla 41013, SpainTel +34955013166Email lcampos@separ.esIntroduction: 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 < 66%.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.Keywords: chronic obstructive pulmonary disease, LABA/LAMA, LABA/ICS, bronchodilator agents, inhaled corticosteroids, triple therapy, statements, Delphi consensus

Introduction: Non-small cell lung cancer (NSCLC) is the most common type of lung neoplasm. Despite surgical resection, it has a high relapse rate, accounting for 30-55% of all cases. Next-generation sequencing (NGS) based on a customized gene panel and the analysis of circulating tumor cells (CTCs) can help identify heterogeneity, stratify high-risk patients, and guide treatment decisions. In this descriptive study involving a small prospective cohort, we focus on the phenotypic characterization of CTCs, particularly concerning EZH2 expression (a member of the Polycomb Repression Complex 2), as well as on the mutation profiles of the tissue using a customized gene panel and their association with poor outcomes in NSCLC., Methods: Isolation and characterization of EZH2 on CTCs were evaluated before surgical resection (CTC1) and one month after surgery (CTC2) in resectable NSCLC patients. Targeted NGS was performed using a customized 50-gene panel on tissue samples from a subset of patients., Results: 76 patients with resectable NSCLC were recruited. The top mutated genes in the cohort included TP53, FLT1, MUC5AC, EGFR, and NLRP3. Pair of genes that had mutually exclusive mutations was TP53-RIN3, and pairs of genes with co-occurring mutations were CD163-TLR4, FGF10-FOXP2, ADAMTSL3-FLT1, ADAMTSL3-MUC5AC and MUC5AC-NLRP3. CTCs decreased significantly between the two time points CTC1 and CTC2 (p<0.0001), and CTCs+ patients with high EZH2 expression had an 87% increased risk of death (p=0.018)., Conclusions: Integrating molecular profiling of tumors and CTC characterization can provide valuable insights into tumor heterogeneity and improve patient stratification for resectable NSCLC., (Copyright © 2024 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Intrathecal drug delivery (IDD) is part of the fourth analgesic step. Evidence on the quality of life of patients with refractory chronic non-cancer pain (CNCP) using these devices and their long-term outcomes is scarce. This study aims to evaluate patients with IDD to assess their HRQoL. Additionally, the study seeks to understand the patients' satisfaction with the treatment and changes in pain magnitude over time. Methods: Adult patients with CNCP and intrathecal drug delivery systems (IDDS) were included. The study population was divided into two groups: less than and more than 15 years of treatment. HRQoL was analyzed using validated questionnaires. Pain reduction was assessed using the visual analog scale (VAS), and treatment satisfaction was evaluated using the Patient Global Impression of Improvement scale. Results: The results indicate a poor HRQoL in IDD patients, with better scores in the group with ≥15 years of treatment. Pain reduction was similar in both groups, and patients reported a positive satisfaction level with the treatment. Conclusions: HRQoL in CNCP patients is severely affected. Long-term IDD patients have a similar or even better HRQoL in some respects compared to those with shorter follow-ups. IDD patients experienced pain reduction, with most feeling better or much better.

Introduction: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/μL., Methods: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92μg/umeclidinium (UMEC) 55μg/vilanterol (VI) 22μg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia., Results: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026., Conclusions: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial., (Copyright © 2024 The Authors. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction: Mortality from COPD has decreased in Spain in recent years, but it is unknown whether this decline has been homogeneous among the different regions., Methods: From the Statistical Portal of the Ministry of Health of Spain we obtained the age-adjusted mortality rates/100,000 inhabitants for men and women in Spain and the Autonomous Communities for the years 1999-2019, using the coding of the International Classification of Diseases (ICD 10, sections J40-J44). With the adjusted rates we performed a jointpoint regression analysis to estimate an annual percentage change (APC), as well as identify possible points of trend change. Statistical significance was considered for a value of p<0.05., Results: During the study period, COPD mortality rates adjusted in Spain decreased from 28.77 deaths/100,000 inhabitants in 1999 to 12.14 deaths/100,000 inhabitants in 2019. We observed a linear decline in COPD mortality in men at national level of -3.67% per year (95% CI -4.1 to -3.4; p<0.001), with differences between the Autonomous Communities. Mortality in women also experienced a decrease in mortality in two phases, with a first period from 1999 to 2006 with a fall of -6.8% per year (95% CI -8.6 to -5.0; p<0.001) and a second period from 2006 to 2019 with a decrease in mortality of -2.1% (95% CI -2.8 to -1.3; p<0.001), with again differences between the Autonomous Communities., Conclusion: Mortality rates from COPD have decreased heterogeneously among the different Autonomous Communities in both men and women., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)

Objective: The aim of this analysis was to describe the patterns of inhaled maintenance therapy according to risk level and to explore the determinants associated with the decision to prescribe inhaled corticosteroids (ICS) in addition to bronchodilator therapy according to risk level as strategy in the follow-up of COPD in daily clinical practice., Methods: EPOCONSUL 2021 is a cross-sectional audit that evaluated the outpatient care provided to patients with a diagnosis of chronic obstructive pulmonary disease (COPD) in respiratory clinics in Spain with prospective recruitment between April 15, 2021 and January 31, 2022., Results: 4225 patients from 45 hospitals in Spain were audited. Risk levels were analyzed in 2678 patients. 74.5% of patients were classified as high risk and 25.5% as low risk according to GesEPOC criteria. Factors associated with the prescription of ICS in low-risk COPD were symptoms suggestive of asthma [OR: 6.70 (3.14-14.29), p<0.001], peripheral blood eosinophilia>300mm 3 [OR: 2.16 (1.10-4.24), p=0.025], and having a predicted FEV1%<80% [OR: 2.17 (1.15-4.08), p=0.016]. In high-risk COPD, factors associated with triple therapy versus dual bronchodilator therapy were a mMRC dyspnea score of ≥2 [OR: 1.97 (1.41-2.75), p<0.001], symptoms suggestive of asthma [OR: 6.70 (3.14-14.29), p<0.001], and a predicted FEV1%<50% [OR: 3.09 (1.29-7.41), p<0.011]., Conclusions: Inhaled therapy in the follow-up of COPD does not always conform to the current guidelines. Few changes in inhaled therapy are made at follow-up visits. The use of ICS is common in COPD patients who meet low-risk criteria in their follow-up and triple therapy in high-risk COPD patients is used as an escalation strategy in patients with high clinical impact. However, a history of exacerbations and eosinophil count in peripheral blood were not factors predicting triple therapy., (Copyright © 2023 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.)

Objective: Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. While two approved fixed-dose inhaled corticosteroid/long-acting muscarinic antagonist (LAMA)/long-acting β 2 -agonist (LABA) triple therapies reduce all-cause mortality (ACM) versus dual LAMA/LABA therapy in patients with COPD, head-to-head studies have not compared the effects of these therapies on ACM. We compared ACM in adults with moderate-to-very severe COPD receiving budesonide/glycopyrrolate/formoterol fumarate (BGF) in ETHOS versus fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in IMPACT using a matching-adjusted indirect comparison (MAIC)., Methods: A systematic literature review identified two studies (ETHOS [NCT02465567]; IMPACT [NCT02164513]) of ≥52 weeks reporting ACM as an efficacy endpoint in patients receiving triple therapy. As ETHOS and IMPACT lack a common comparator, an unanchored MAIC compared ACM between licensed doses of BGF (320/18/9.6 μg) from ETHOS and FF/UMEC/VI (100/62.5/25 μg) from IMPACT in patients with moderate-to-very severe COPD. Using on- and off-treatment data from the final retrieved datasets of the intention-to-treat populations, BGF data were adjusted according to aggregate FF/UMEC/VI data using 11 baseline covariates; a supplementary unadjusted indirect treatment comparison was also conducted. P -values for these post-hoc analyses are not adjusted for Type I error., Results: ACM over 52 weeks was statistically significantly reduced by 39% for BGF versus FF/UMEC/VI in the MAIC (hazard ratio [HR] [95% CI]: 0.61 [0.38, 0.95], p  = 0.030) and unadjusted analysis (HR [95% CI]: 0.61 [0.41, 0.92], p  = 0.019)., Conclusion: In this MAIC, which adjusted for population heterogeneity between ETHOS and IMPACT, ACM was significantly reduced with BGF versus FF/UMEC/VI in patients with moderate-to-very severe COPD.

Introduction: The aim of our work has been to describe the results of the clinical audit carried out in 2021 and to compare the results with 2015 EPOCONSUL audit., Methods: EPOCONSUL 2021 is a cross-sectional audit that evaluated the outpatient care provided to patients with a diagnosis of chronic obstructive pulmonary disease (COPD) in respiratory clinics in Spain with prospective recruitment between April 15, 2021, and January 31, 2022., Results: A total of 45 hospitals participated in the 2021 audit and 4.225 clinical records of patients were evaluated. Clinical phenotype according to the Spanish National Guidelines for COPD care (GesEPOC) was reported in 63.1% of the audited patients, and the COPD type assessment for the Global initiative for chronic Obstructive Lung Disease (GOLD) was present in 38.3%. There was an improved compliance with clinical practice guideline (CPG) recommendations in the 2021 audit with respect to the 2015 audit. There was an increase in the proportion of cases with alfa-1-antitrypsin serum level testing available (audit 1: 18.9%; audit 2: 38.7%, p<0.001) and 6-min walk test carried out (audit 1: 24%; audit 2: 45.2%, p<0.001). However, these significant variations adherence to CPG recommendations were not reached for the clinical evaluation and therapeutic intervention category when adjusting for patient and resource variables., Conclusions: The 2021 EPOCONSUL audit showed increased adherence to recommendations although they seem to be related to the availability of resources for care. These results should be taken into account in order to establish improvements in resources to achieve a better quality of care., (Copyright © 2023 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.)

Background: 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., Research Question: Do COPD patients in Spain initiating SITT vs MITT have improved persistence, exacerbations, and health care resource utilization?, Study Design and Methods: 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., Results: 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 < .001), reduced risk of exacerbations (HR = 0.68; 95% CI = 0.61-0.77; P = .001), and lower all-cause mortality risk (HR = 0.67; 95% CI = 0.63-0.71, P = .027), compared with MITT patients. SITT was associated with significantly reduced health care resource use (mean annual cost savings: €403 vs MITT). For both SITT and MITT, persistence was associated with improved exacerbation rates vs nonpersistence, and substantial adjusted mean annual cost savings (€2,115 and €2,700, respectively)., Interpretation: 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., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

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 prospective, multicenter, observational study and followed up for 1 year, during which BEC were analysed 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<.05., 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 FEV 1 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=.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=.183) but FeNO predicted severe episodes more accurately than BEC (AUC 0.607 vs 0.539, P<.05). Combining the two biomarkers enhanced the detection of moderate and severe COPD exacerbations., 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., (Copyright © 2021 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2020 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., Trial Registration: ClinicalTrials.gov NCT04326400; https://clinicaltrials.gov/ct2/show/NCT04326400., (©Joan B Soriano, Esteve Fernández, Álvaro de Astorza, Luis A Pérez de Llano, Alberto Fernández-Villar, Dolors Carnicer-Pont, Bernardino Alcázar-Navarrete, Arturo García, Aurelio Morales, María Lobo, Marcos Maroto, Eloy Ferreras, Cecilia Soriano, Carlos Del Rio-Bermudez, Lorena Vega-Piris, Xavier Basagaña, Josep Muncunill, Borja G Cosio, Sara Lumbreras, Carlos Catalina, José María Alzaga, David Gómez Quilón, Carlos Alberto Valdivia, Celia de Lara, Julio Ancochea. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 21.09.2020.)

The emergence of a fixed-dose combination (FDC) of a long-acting ß 2 -agonist (LABA), a long-acting muscarinic antagonist (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 the way towards more personalized treatment., (Copyright © 2019 The Author(s). Published by Elsevier España, S.L.U. All rights reserved.)