Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial.

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.

Immunosenescence, Immune Fitness and Vaccination Schedule in the Adult Respiratory Patient.

Immunosenescence is the gradual deterioration of the immune system caused by advancing age. It is associated with a reduced ability to respond to infections and develop long-term immune memory. It plays a key role in the development of respiratory diseases that are more common in older people, such as asthma, COPD, diffuse interstitial disease and respiratory infections in the elderly. We call immune fitness the establishment of lifestyle habits that can improve our immune capacity. We now know that good eating habits, good social relationships, not smoking, limiting alcohol consumption, exercising, controlling stress levels and establishing a proper vaccination programme can slow down the process of immunosenescence. Influenza and pneumococcal vaccines (PCV13 and PPSV23 conjugate) are well established in the adult vaccination schedule. The new pneumococcal vaccines PCV15 and PCV20 will help to extend protection against pneumococcal disease in adults. The vaccine against COVID-19 is currently the most useful tool to prevent the disease and reduce its pathogenicity. COPD patients and others with respiratory diseases may benefit from prevention of herpes zoster and Bordetella pertussis through vaccination. Respiratory syncytial virus (RSV) vaccine may be another vaccine to be added to the schedule, pending the results of its studies.

La inmunosenescencia es el deterioro gradual del sistema inmune provocado por el avance de la edad. Se asocia a una menor capacidad para responder a las infecciones y desarrollar memoria inmune a largo plazo. Es parte fundamental en el desarrollo de las enfermedades respiratorias más frecuentes en edades avanzadas, como el asma, la EPOC, la patología intersticial difusa y las infecciones respiratorias del anciano.Llamamos fitness inmunológico al establecimiento de unos hábitos de vida que puedan mejorar nuestra capacidad inmunitaria. Actualmente sabemos que tener buenos hábitos alimentarios, buenas relaciones sociales, no fumar, limitar el consumo de alcohol, hacer ejercicio, controlar los niveles de estrés y establecer un correcto programa de vacunación permiten ralentizar el proceso de inmunosenescencia.Las vacunas de la gripe y las antineumocócicas (la conjugada PCV13 y la PPSV23) están bien establecidas en el calendario vacunal del adulto. Las nuevas vacunas antineumocócicas PCV15 y PCV20 van a servir para ampliar la protección contra la enfermedad neumocócica en el adulto. La vacuna contra la COVID-19 es, en el momento actual, la herramienta más útil para prevenir la enfermedad y disminuir su patogenicidad. Los pacientes con EPOC y otros con enfermedades respiratorias podrían beneficiarse de la prevención del herpes zóster y Bordetella pertussis mediante la vacunación. La vacuna contra el virus respiratorio sincitial (VRS) puede ser otra de las siguientes que formen parte de este calendario, en espera de los resultados de sus estudios.

Elevated levels of arginase activity are related to inflammation in patients with COPD exacerbation.

INTRODUCTION: Within the pathogenesis of the chronic obstructive pulmonary disease (COPD) there are interactions between different inflammatory mediators that are enhanced during an exacerbation. Arginase is present in bronchial epithelial cells, endothelial, fibroblasts and alveolar macrophages, which make it a probable key enzyme in the regulation of inflammation and remodelling. We aimed to find a potential relationship between arginase activity, inflammatory mediators in COPD patients in stable phase and during exacerbations. METHODS: We performed a prospective, observational study of cases and controls, with 4 study groups (healthy controls, stable COPD, COPD during an exacerbation and COPD 3 months after exacerbation). We measured arginase, inflammation markers (IL-6, IL-8, TNF-∝, IFN-γ and C reactive protein), and mediators of immunity: neutrophils, monocytes, total TCD3 + lymphocytes (CD3ζ), CD4 + T cells, CD8 + T cells, NK cells. RESULTS: A total of 49 subjects were recruited, average age of 69.73 years (59.18% male). Arginase activity is elevated during an exacerbation of COPD, and this rise is related to an increase in IL-6 production. The levels of IL-6 and IL-8 remained elevated in patients with COPD at 3 months after hospital exacerbation. We did not find a clear relationship between arginase activity, immunity or with the degree of obstruction in COPD patients. CONCLUSIONS: Arginase activity is elevated during an exacerbation of COPD, and it could be related to an increase in the production of IL-6. Levels of IL-6, IL-8, and arginase activity remain elevated in patients with COPD at 3 months after hospital exacerbation. Arginase activity could contribute to the development of COPD.

Compassionate use of tocilizumab in severe SARS-CoV2 pneumonia.

INTRODUCTION: Tocilizumab (TCZ) is an interleukin-6 receptor antagonist, which has been used for the treatment of severe SARS-CoV-2 pneumonia (SSP), which aims to ameliorate the cytokine release syndrome (CRS) induced acute respiratory distress syndrome (ARDS). However, there are no consistent data about who might benefit most from it. METHODS: We administered TCZ on a compassionate-use basis to patients with SSP who were hospitalized (excluding intensive care and intubated cases) and who required oxygen support to have a saturation >93%. The primary endpoint was intubation or death after 24 h of its administration. Patients received at least one dose of 400 mg intravenous TCZ from March 8, 2020 to April 20, 2020. RESULTS: A total of 207 patients were studied and 186 analyzed. The mean age was 65 years and 68% were male patients. A coexisting condition was present in 68% of cases. Prognostic factors of death were older age, higher IL-6, d-dimer and high-sensitivity C-reactive protein (HSCRP), lower total lymphocytes, and severe disease that requires additional oxygen support. The primary endpoint (intubation or death) was significantly worst (37% vs 13%, p < 0·001) in those receiving the drug when the oxygen support was high (FiO2 >0.5%). CONCLUSIONS: TCZ is well tolerated in patients with SSP, but it has a limited effect on the evolution of cases with high oxygen support needs.

[SEPAR Recommendations for COVID-19 Vaccination in Patients With Respiratory Diseases]. / Recomendaciones SEPAR sobre la vacuna COVID-19 en las enfermedades respiratorias.

The Spanish Society of Pneumonology and Thoracic Surgery (SEPAR) has elaborated this document of recommendations for COVID-19 vaccination in patients with respiratory diseases aimed to help healthcare personnel make decisions about how to act in case of COVID-19 vaccination in these patients.The recommendations have been developed by a group of experts in this field after reviewing the materials published up to March 7, 2021, the information provided by different scientific societies, drug agencies and the strategies of the governmental bodies up to this date.We can conclude that COVID-19 vaccines are not only safe and effective, but also prior in vulnerable patients with chronic respiratory diseases. In addition, an active involvement of healthcare professionals, who manage these diseases, in the vaccination strategy is the key to achieve good adherence and high vaccination coverage.

Do not do in COPD: consensus statement on overuse.

Background: To identify practices that do not add value, cause harm, or subject patients with chronic obstructive pulmonary disease (COPD) to a level of risk that outweighs possible benefits (overuse). Methods: A qualitative approach was applied. First, a multidisciplinary group of healthcare professionals used the Metaplan technique to draft and rank a list of overused procedures as well as self-care practices in patients with stable and exacerbated COPD. Second, in successive consensus-building rounds, description files were created for each "do not do" (DND) recommendation, consisting of a definition, description, quality of supporting evidence for the recommendation, and the indicator used to measure the degree of overuse. The consensus group comprised 6 pulmonologists, 2 general practitioners, 1 nurse, and 1 physiotherapist. Results: In total, 16 DND recommendations were made for patients with COPD: 6 for stable COPD, 6 for exacerbated COPD, and 4 concerning self-care. Conclusion: Overuse poses a risk for patients and jeopardizes care quality. These 16 DND recommendations for COPD will lower care risks and improve disease management, facilitate communication between physicians and patients, and bolster patient ability to provide self-care.

Executive summary of the SEPAR recommendations for the diagnosis and treatment of non-small cell lung cancer. / Sumario ejecutivo de las recomendaciones SEPAR de diagnóstico y tratamiento del cáncer de pulmón de células no pequeñas.

The Thoracic Surgery and Thoracic Oncology groups of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) have backed the publication of a handbook on recommendations for the diagnosis and treatment of non-small cell lung cancer. Due to the high incidence and mortality of this disease, the best scientific evidence must be constantly updated and made available for consultation by healthcare professionals. To draw up these recommendations, we called on a wide-ranging group of experts from the different specialties, who have prepared a comprehensive review, divided into 4 main sections. The first addresses disease prevention and screening, including risk factors, the role of smoking cessation, and screening programs for early diagnosis. The second section analyzes clinical presentation, imaging studies, and surgical risk, including cardiological risk and the evaluation of respiratory function. The third section addresses cytohistological confirmation and staging studies, and scrutinizes the TNM and histological classifications, non-invasive and minimally invasive sampling methods, and surgical techniques for diagnosis and staging. The fourth and final section looks at different therapeutic aspects, such as the role of surgery, chemotherapy, radiation therapy, a multidisciplinary approach according to disease stage, and other specifically targeted treatments, concluding with recommendations on the follow-up of lung cancer patients and surgical and endoscopic palliative interventions in advanced stages.

Spontaneous Hemothorax in a Patient With von Recklinghausen's Disease.

Type I neurofibromatosis (NF-1) is a rare autosomal dominant disease. It can affect any organ system including vascular tissues. A 53 years old man, with a past medical history of NF-1, retinitis pigmentosa and hypertension attended to the emergency department for chest pain and palpitations and was discharged 2 days after acute coronary syndrome was ruled out. During this admission an echocardiogram was performed which showed a left ventricular hypertrophy with normal ejection fraction and a chest X-ray which revealed no pathologic images. No invasive procedures were preformed. Three days after discharge, he returned to our hospital for sudden onset of oppressive chest pain in the right arm, irradiated to the ipsilateral shoulder, chest and back. After several tests, a diagnosis of hemothorax was made. Hemoglobin levels declined during the first 2 days of admission from 12.1 to 9.6 g/dL, although the patient remained hemodynamic stable. An arteriography was performed, which showed the presence of bleeding from a branch of the right subclavian artery, which was selectively catheterized and embolized with coils. Afterwards, a video-assisted thoracoscopy was made, in order to drain the hemothorax and to carry out a visual review of the pleural cavity. The patient had a good clinical and radiologic progression and was discharged after few days. After a year of follow-up, the patient has remained clinically asymptomatic with no further episodes of active bleeding.