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Purpose: The aim of this study was to assess whether new-generation shear wave elastography (SWE) is suitable for the characterization of lung subpleural lesions.Methods: In total, 190 consecutive patients with subpleural lung lesions received ultrasonography and SWE. Patients with suspected malignancy underwent ultrasound-guided transthoracic needle biopsy. Final diagnoses were made on the basis of patients’ clinical course, microbiological studies, and histological results. SWE was also performed in 25 healthy volunteers.Results: We found no statistically significant differences in stiffness between lung carcinomas, lung metastases, and pneumonia (P=0.296) or between different histological types of lung cancer (P=0.393). Necrosis was associated with reduced stiffness in pneumonia. Excluding necrotic lesions, pneumonia showed higher stiffness than lung carcinomas (2.95±0.68 m/s vs. 2.60±0.54 m/s, P=0.006). Chronic pneumonia showed increased stiffness (3.03±0.63 m/s), probably due to the presence of fibrotic tissue on histology. Pleural effusion was associated with a statistically significant reduction in stiffness, both in lung carcinomas (P=0.004) and lung metastases (P=0.002). The presence of air in healthy lung tissue may lead to incorrect speed estimates due to shear wave reflection (very high values, 14.64±2.19 m/s).Conclusion: Transthoracic SWE could not distinguish lung malignancy from pneumonia, or between different histological types of lung carcinomas. In particular, SWE seems unable to resolve the clinical dilemma of chronic subpleural consolidations.

Idiopathic pulmonary fibrosis (IPF) is a specific form of chronic, progressive, fibrosing interstitial pneumonia of unknown cause that leads to respiratory failure and death within few years of diagnosis. Pulmonary hypertension (PH) is a common complication in IPF, where it is strongly associated with increased morbidity and mortality. Patients with IPF and PH have particularly poor prognosis, despite current best medical therapies and the anti-fibrotic therapy with pirfenidone or nintedanib. The aim of our study was to assess the clinical and prognostic impact of PH in patients affected by IPF, already treated with pirfenidone or nintedanib. Seventy-four consecutive outpatients with a diagnosis of IPF, in therapy with pirfenidone or nintedanib, were prospectively enrolled in the study. All patients underwent pulmonary and cardiology assessment by clinical exam, spirometry, DLCO test, chest CT, 6MWT and echocardiography performed by a cardiologist experienced in PH in an ambulatory setting under resting conditions. GAP index has been determinate for all patients. During follow-up, all patients were evaluated every 6 months, or less if necessary. Data about mortality were then collected in a 3-year follow-up. Of the seventy-four patients enrolled, 38 were treated with pirfenidone and 36 with nintedanib. The two groups were comparable for age, gender, FVC, DLCO and PAPS. The patients were also divided in four groups, based on presence of mild/moderate/severe PH by echocardiography at baseline. Significant differences were found for DLCO and the GAP index. Severity of PH was significantly associated with a reduction of DLCO and with an increased GAP index. Survival was directly correlated with 6MWT (R = 0.48), DLCO (R = 0.29, p

Continuous positive airway pressure (CPAP) is the "gold-standard" therapy for obstructive sleep apnea (OSA), but the main problem is the poor adherence. Therefore, we have searched for the causes of poor adherence to CPAP therapy by applying predictive machine learning (ML) methods. The study was conducted on OSAs in nighttime therapy with CPAP. An outpatient follow-up was planned at 3, 6, 12 months. We collected several parameters at the baseline visit and after dividing all patients into two groups (Adherent and Non-adherent) according to therapy adherence, we compared them. Statistical differences between the two groups were not found according to baseline characteristics, except gender (P< .01). Therefore, we applied ML to predict CPAP adherence, and these predictive models showed an accuracy and sensitivity of 68.6% and an AUC (area under the curve) of 72.9% through the SVM (support vector machine) classification method. The identification of factors predictive of long-term CPAP adherence is complex, but our proof of concept seems to demonstrate the utility of ML to identify subjects poorly adherent to therapy. Therefore, application of these models to larger samples could aid in the careful identification of these subjects and result in important savings in healthcare spending.

Purpose Patients affected by COVID-19 are assumed to be at high risk of developing swallowing disorders. However, to our best knowledge, data on the characteristics and incidence of dysphagia associated with COVID-19 are lacking, especially in non-intubated patients. Therefore, we investigated the onset of swallowing disorders in patients with laboratory-confirmed COVID-19 infection who have not been treated with invasive ventilation, in order to evaluate how the virus affected swallowing function regardless of orotracheal intubation. Methods We evaluated 41 patients admitted to the COVID department of our Hospital when they had already passed the acute phase of the disease and were therefore asymptomatic but still positive for SARS-CoV-2 RNA by RT-PCR. We examined patients’ clinical history and performed the Volume-Viscosity Swallow Test (VVST). Each patient also answered the Swallowing Disturbance Questionnaire (SDQ). After 6 months, we performed a follow-up in patients with swallowing disorders. Results Eight of 41 patients (20%) presented with dysphagia symptoms during hospitalization and 2 of them (25%) still presented a SDQ high score and swallowing disorders with liquid consistency after 6 months. Conclusion Non-intubated patients can experience various grades of swallowing impairment that probably directly related to pulmonary respiratory function alterations and viral direct neuronal lesive activity. Although these symptoms show natural tendency to spontaneous resolution, their impact on a general physical impaired situation should not be underestimated, since it can adversely affect patients’ recovery from COVID-19 worsening health outcomes.

The prognosis of the coronavirus disease 2019 (COVID-19) patients is variable and depends on several factors. Current data about the impact of chronic obstructive pulmonary disease (COPD) and smoking on the clinical course of COVID-19 are still controversial. This study evaluated the prevalence and the prognosis of COPD patients and smokers in a cohort of 521 patients admitted to four intermediate Respiratory Intensive Care Units (Puglia, Italy) with respiratory failure due to COVID-19 pneumonia. The prevalence of COPD and current smokers was 14% and 13%, respectively. COPD patients had a higher 30-day all-cause mortality than non-COPD patients. Former smokers compared to never smokers and current smokers had higher 30-day all-cause mortality. COPD patients and former smokers had more comorbidities. This study described the prevalence and the outcomes of COPD patients and smokers in a homogenous cohort of COVID-19 patients. The study showed that the prevalence of COPD and current smokers was not high, suggesting that they were not at increased risk of getting the infection. However, when SARS-CoV-2 infection occurred, COPD patients and former smokers were those with the highest all-cause mortality, which seemed to be mainly related to the presence of comorbidities and not to COPD and smoking itself.

Introduction Obstructive sleep apnoea (OSA) is an underdiagnosed condition frequently associated with glycaemic control impairment in patients with type 2 diabetes. Aim To assess the relationship between glycometabolic parameters and OSA in obese non-diabetic subjects. Methods Ninety consecutive subjects (mean age 44.9 ± 12 years, mean BMI 42.1 ± 9 kg/m2) underwent polysomnography and a 2-h oral glucose tolerance test (OGTT). Results OSA was identified in 75% of subjects, with a higher prevalence of males compared to the group of subjects without OSA (62% vs 32%, p = 0.02). Patients with OSA had comparable BMI (42.8 kg/m2 vs 39.4 kg/m2), a higher average HbA1c (5.8% vs 5.4%, p p = 0.009) and diastolic blood pressure (81.1 mmHg vs 76.2 mmHg, p = 0.046) than obese subjects without OSA. HbA1c and 2 h-PG were found to be correlated with the apnoea-hypopnoea index (AHI; r = 0.35 and r = 0.42, respectively) and with percent of sleep time with oxyhaemoglobin saturation r = 0.44 and r = 0.39, respectively). Further, in a linear regression model, ST90 and AHI were found to be the main determinants of 2 h-PG (β = 0.81, p β = 0.75, p = 0.02, respectively) after controlling for age, sex, waist circumference, physical activity, and C-reactive protein. Similarly, ST90 and AHI persisted as independent determinants of HbA1c (β = 0.01, p = 0.01 and β = 0.01, p = 0.01, respectively). Conclusion Beyond the traditional clinical parameters, the presence of a normal-high value of 2 h-PG and HbA1c should raise suspicion of the presence of OSA in obese subjects.

Asthma inflammation may feature an imbalance between oxidative stress and antioxidant defenses. Oxidative stress induces propagation of airways inflammation and corticosteroid insensitivity contributing to poor asthma control, and frequent severe acute exacerbations. This study assessed inflammation and oxidative stress in severe asthmatic subjects and evaluated the possible correlations between inflammatory and oxidative stress markers investigated and asthma severity.Fifty-three patients with severe asthma, 11 patients with mild-moderate asthma and 12 healthy subjects were enrolled and underwent fractional exhaled nitric oxide (FENO) analysis and blood and sputum count cell collection. The content of mitochondrial DNA (MtDNA) and nuclear DNA (nDNA) was measured in exhaled breath condensate (EBC) by Real Time PCR and the ratio between MtDNA/nDNA was calculated. We detected MtDNA/nDNA in the EBC of severe asthmatics.We found higher exhaled MtDNA/nDNA in severe asthmatics respectively compared to mild-moderate ones and to healthy controls (10.4±2.2 vs 7.9±2.5, p0.05 and 10.4±2.2 vs 6.51±0.21, p0.05). The level of exhaled MtDNA/nDNA was significantly higher in Non-T2 endotype severe asthmatics than T2 (14.07±10. 8 vs 6.5±5.5, p0.05).Oxidative stress marker (MtDNA/nDNA) is increased significantly with asthma severity and may be useful for endotyping severe asthma.

Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS), which worsen patients’ health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics, but not optimally controlled by omalizumab. We retrospectively enrolled uncontrolled severe asthmatic patients who switched from OMA to MEP during the last two years. Information included blood eosinophil count, asthma control test (ACT), spirometry, serum IgE, fractional exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, visits and diagnostic exams. Within the perspective of Italian National Health System, a pre- and post-MEP 12-month standardized total cost per patient was calculated. 33 patients were enrolled: five males, mean age 57 years, disease onset 24 years. At OMA discontinuation, 88% were OCS-dependent with annual mean rate of 4.0 clinically significant exacerbations, 0.30 exacerbations needing emergency room visits or hospitalization; absenteeism due to disease was 10.4 days per patient. Switch to MEP improved all clinical outcomes, reducing total exacerbation rate (RR = 0.06, 95% CI 0.03–0.14), OCS-dependent patients (OR = 0.02, 95% CI 0.005–0.08), and number of lost working days (Δ = − 7.9, 95% CI − 11.2 to − 4.6). Pulmonary function improved, serum IgE, FeNO and eosinophils decreased. Mean annual costs were €12,239 for OMA and €12,639 for MEP (Δ = €400, 95% CI − 1588–2389); the increment due to drug therapy (+ €1,581) was almost offset by savings regarding all other cost items (− €1,181). Patients with severe eosinophilic asthma, not controlled by OMA, experienced comprehensive benefits by switching to MEP with only slight increases in economic costs.

Introduction Several studies have previously demonstrated that long-term exposure to outdoor pollution present airway inflammation in term of an increase of sputum neutrophils. Aim and methods The aim of our study was to evaluate the level of airway inflammation by induced sputum in a group of 15 non-professionally exposed population of well-characterized COPD patients, residing in urban areas with high rate of outdoor pollution, compared to a control group of 13 individuals with COPD, living in rural areas with a low pollution rate. All participants underwent spirometry and sputum induction. Results A statistically significant increase in the percentage of neutrophil cell count was found among the residents in urban areas compared to those living in rural regions (89.1 vs 79.0, p Conclusions In conclusion, we showed that non-professionally exposed patients with COPD residing in highly-polluted urban areas had greater airway inflammation in terms of sputum neutrophils compared to a population with very similar characteristics, living in rural areas with lower outdoor pollution. The results of this pilot study may be relevant for the long term effect of environmental outdoor pollution in vulnerable patients like those with COPD.

Tuberculosis (TB) is a severe infectious disease that still represents a major cause of mortality and morbidity worldwide. For these reasons, clinicians and radiologists should use all the available diagnostic tools in the assessment of the disease in order to provide precise indications about starting an anti-tubercular treatment and reduce risk of TB transmission and complications especially in developing countries where the disease is still endemic. As TB mycobacteria are mainly transmitted through respiratory droplets, the pulmonary parenchyma is usually the first site of infection. As a result, chest imaging plays a central role in the diagnostic process. Thoracic ultrasound (TUS) is a portable, non-invasive, radiation-free, and cost-contained technology which could be easily available in resource-limited settings. This perspective article focuses on the potential role of TUS in the diagnosis and management of patients with pulmonary TB. Unfortunately, there are still insufficient evidence and too contrasting data to judge TUS as an appropriate diagnostic method for the screening of the disease. Despite this, TUS may have a useful role in identifying pleural and anterior pericardial effusions or in the identification of abscesses of the anterior chest wall and paraspinal collections in low- and middle-income settings. In addition, TUS seems to have a milestone role in guiding minimally invasive interventional procedures, such as placement of chest tubes, drainage of loculated collections, thoracentesis and pericardiocentesis, and percutaneous biopsy of subpleural pulmonary consolidations or pleural plaques.

The prevalence of asthma in Italy is estimated to be around 4%; it affects approximately 2,000,000 citizens, and up to 80-90% of patients have mild-to-moderate asthma. Despite the clinical relevance of mild-to-moderate asthma, longitudinal observational data are very limited, including data on disease progression (worsening vs. improvement), the response to treatment, and prognosis. Studies are needed to develop long-term, observational, real-life research in large cohorts. The primary outcomes of this study will be based on prospective observation and the epidemiological evolution of mild and moderate asthma. Secondary outcomes will include patient-reported outcomes, treatments over time, disease-related functional and inflammatory patterns, and environmental and life-style influences.This study, called the Mild/Moderate Asthma Network of Italy (MANI), is a research initiative launched by the Italian Respiratory Society and the Italian Society of Allergology, Asthma and Clinical Immunology. MANI is a cluster-based, real world, cross-sectional, prospective, observational cohort study that includes 20,000 patients with mild-to-moderate asthma. (ClinicalTrials.gov Identifier: NCT04796844).Despite advances in asthma care, several research gaps remain to be addressed through clinical research. This study will add important new knowledge about long-term disease history, the transferability of clinical research results to daily practice, the efficacy of currently recommended strategies, and their impact on the burden and evolution of the disease.MANI:Mild/Moderate Asthma Network of ItalySANI:Severe Asthma Network ItalyGINA:Global Initiative for AsthmaSABA:short acting β2-agonistsICS:inhaled corticosteroidsCRF:Case Report Form.

The pandemic spread of the new Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has raised the necessity to identify an appropriate imaging method for early diagnosis of coronavirus disease 2019 (COVID-19). Chest Computed Tomography (CT) has been regarded as the mainstay of imaging evaluation for pulmonary involvement in the early phase of the pandemic. However, due to the poor specificity of the radiological pattern and the disruption of Radiology Centers functionality linked to an excessive demand for exams, the American College of Radiology (ACR) has advised against CT use for a screening purpose. Lung ultrasound (LUS) is a point-of care imaging tool that is fast available and easy to disinfect. These advantages have determined a “pandemic” increase of its use for early detection of COVID-19 pneumonia in Emergency Departments. However, LUS findings in COVID-19 patients are even less specific than those detectable on CT scan. The scope of this perspective article is to discuss about the great number of diseases and pathologic conditions that may mimic COVID-19 pneumonia on LUS examination.

Background: In the current coronavirus disease-2019 (COVID-19) pandemic, lung ultrasound (LUS) has been extensively employed to evaluate lung involvement and proposed as a useful screening tool for early diagnosis in the emergency department (ED), prehospitalization triage, and treatment monitoring of COVID-19 pneumonia. However, the actual effectiveness of LUS in characterizing lung involvement in COVID-19 is still unclear. Our aim was to evaluate LUS diagnostic performance in assessing or ruling out COVID-19 pneumonia when compared with chest CT (gold standard) in a population of SARS-CoV-2-infected patients.Methods: A total of 260 consecutive RT-PCR confirmed SARS-CoV-2-infected patients were included in the study. All the patients underwent both chest CT scan and concurrent LUS at admission, within the first 6–12 h of hospital stay.Results: Chest CT scan was considered positive when showing a “typical” or “indeterminate” pattern for COVID-19, according to the RSNA classification system. Disease prevalence for COVID-19 pneumonia was 90.77%. LUS demonstrated a sensitivity of 56.78% in detecting lung alteration. The concordance rate for the assessment of abnormalities by both methods increased in the case of peripheral distribution and middle-lower lung location of lesions and in cases of more severe lung involvement. A total of nine patients had a “false-positive” LUS examination. Alternative diagnosis included chronic heart disease (six cases), bronchiectasis (two cases), and subpleural emphysema (one case). LUS specificity was 62.50%. Collateral findings indicative of overlapping conditions at chest CT were recorded also in patients with COVID-19 pneumonia and appeared distributed with increasing frequency passing from the group with mild disease (17 cases) to that with severe disease (40 cases).Conclusions: LUS does not seem to be an adequate tool for screening purposes in the ED, due to the risk of missing some lesions and/or to underestimate the actual extent of the disease. Furthermore, the not specificity of LUS implies the possibility to erroneously classify pre-existing or overlapping conditions as COVID-19 pneumonia. It seems more safe to integrate a positive LUS examination with clinical, epidemiological, laboratory, and radiologic findings to suggest a “virosis.” Viral testing confirmation is always required.

In patients presenting with classical features of CAP (i.e., new peripheral pulmonary consolidations and symptoms including fever, cough, and dyspnea), a clinical response to the appropriate therapy occurs in few days. When clinical improvement has not occurred and chest imaging findings are unchanged or worse, a more aggressive approach is needed in order to exclude other non-infective lesions (including neoplasms). International guidelines do not currently recommend the use of transthoracic ultrasound (TUS) as an alternative to chest X-ray (CXR) or chest computed tomography (CT) scan for the diagnosis of CAP. However, a fundamental role for TUS has been established as a guide for percutaneous needle biopsy (US-PNB) in pleural and subpleural lesions. In this retrospective study, we included 36 consecutive patients whose final diagnosis, made by a US-guided percutaneous needle biopsy (US-PTNB), was infectious organizing pneumonia (OP). Infective etiology was confirmed by additional information from microbiological and cultural studies or with a clinical follow-up of 6–12 months after a second-line antibiotic therapy plus corticosteroids. All patients have been subjected to a chest CT and a systematic TUS examination before biopsy. This gave us the opportunity to explore TUS performance in assessing CT findings of infective OP. TUS sensitivity and specificity in detecting air bronchogram and necrotic areas were far lower than those of CT scan. Conversely, TUS showed superiority in the detection of pleural effusion. Although ultrasound findings did not allow the characterization of chronic subpleural lesions, TUS confirmed to be a valid diagnostic aid for guiding percutaneous needle biopsy of subpleural consolidations.

Limited data on myoglobin and infectious diseases are available. In this study, we evaluate the potential role of myoglobin in predicting poor outcome in patients with Sars-Cov2 pneumonia.One hundred and twenty-one Sars-Cov 2 patients with an average age of 69.9 ± 13.2 years, and symptoms duration of 8.8 ± 7.9 days were enrolled in the study. At the admission, the serum levels of myoglobin, erythrocyte sedimentation rate, C reactive protein (CRP), procalcitonin, ferritin, creatine phosphokinase, creatinine, fibrinogen, d-dimers, lactic dehydrogenase, troponin (Tn-I), creatine kinase myocardial band (CK-MB), complement fractions C3 and C4, immunoglobulins, interleukin 6 were evaluated. We also assessed the patients' complete clinical history and performed a thorough physical examination including age, disease history, and medications.Twenty-four (20%) patients died, and 18 (15%) patients required intensive care. The mean time between symptoms onset and death was 12.4 days ± 9.1. Univariate analysis of the patients' data highlighted some independent risk factors for mortality in COVID-19, including higher neutrophils rate (HR: 1.171), lower lymphocyte rate (HR: 0.798), high CK-MB serum levels (HR: 1.6), high Tn-I serum levels (HR: 1.03), high myoglobin serum levels (HR: 1.014), Alzheimer (HR 5.8), and higher CRP values (HR: 1.011). Cox regression analysis model revealed that higher serum values of myoglobin (HR 1.003; 95%CI: 1.001-1.006; p = 0.01), and CRP (HR 1.012; 95% CI: 1.001-1.023; p = 0.035) could be predictors of mortality in COVID-19 patients. The value of the myoglobin level for predicting 28 days-mortality using ROC curve was 121.8 ng/dL. Lower survival rate was observed in patients with serum levels of myoglobin121.8 ng/dL (84% vs 20% respectively, p = 0.0001).Our results suggest that higher serum levels of myoglobin could be a considerable and effective predictor of poor outcomes in COVID-19 patients; a careful follow-up in these patients is strongly suggested. The possibility of enhancing these findings in other cohorts of COVID-19 patients could validate the clinical value of myoglobin as a biomarker for worse prognosis in COVID-19.

Background Asthma and bronchiectasis are different conditions that frequently coexist. The prevalence of bronchiectasis rises considerably in subjects with severe asthma (25%-51%). Objective We evaluated the clinical and biological efficacy of mepolizumab on our pilot population of severe uncontrolled asthmatics with bronchiectasis not related to other pathologies. Patients and methods Four patients with severe uncontrolled asthma and diagnosed as bronchiectasis were recruited and started biological treatment with mepolizumab. Standard investigations were performed in all four patients at baseline (T0), after 3 months (T1) and after 1 year (T2) of treatment. Results After 1 year (T2) of therapy with mepolizumab, patients showed a significant increment of asthma control test value (12±1.1 vs 24.5±0.3, P

Introduction: Obstructive sleep apnea syndrome has become an important public health concern. Polysomnography is traditionally considered an established and effective diagnostic tool providing information on the severity of obstructive sleep apnea syndrome and the degree of sleep fragmentation. However, the numerous steps in the polysomnography test to diagnose obstructive sleep apnea syndrome are costly and time consuming. This study aimed to test the efficacy and clinical applicability of different machine learning methods based on demographic information and questionnaire data to predict obstructive sleep apnea syndrome severity. Materials and methods: We collected data about demographic characteristics, spirometry values, gas exchange (PaO2, PaCO2) and symptoms (Epworth Sleepiness Scale, snoring, etc.) of 313 patients with previous diagnosis of obstructive sleep apnea syndrome. After principal component analysis, we selected 19 variables which were used for further preprocessing and to eventually train seven types of classification models and five types of regression models to evaluate the prediction ability of obstructive sleep apnea syndrome severity, represented either by class or by apnea–hypopnea index. All models are trained with an increasing number of features and the results are validated through stratified 10-fold cross validation. Results: Comparative results show the superiority of support vector machine and random forest models for classification, while support vector machine and linear regression are better suited to predict apnea–hypopnea index. Also, a limited number of features are enough to achieve the maximum predictive accuracy. The best average classification accuracy on test sets is 44.7 percent, with the same average sensitivity (recall). In only 5.7 percent of cases, a severe obstructive sleep apnea syndrome (class 4) is misclassified as mild (class 2). Regression results show a minimum achieved root mean squared error of 22.17. Conclusion: The problem of predicting apnea–hypopnea index or severity classes for obstructive sleep apnea syndrome is very difficult when using only data collected prior to polysomnography test. The results achieved with the available data suggest the use of machine learning methods as tools for providing patients with a priority level for polysomnography test, but they still cannot be used for automated diagnosis.

Background. Low molecular weight heparins (LMWHs) are administered routinely to COVID-19 patients. Systemic reactions to LMWHs (both IgE-mediated and non IgE-mediated) are considered rare. Particularly, a single case of drug-related reaction with eosinophilia and systemic symptoms (DRESS) due to enoxaparin has been described in the literature. Here, we report on the first case of DRESS related to administration of fondaparinux.Case presentation. An elderly woman was diagnosed with COVID-19, during the “first wave” of the pandemics in Italy, and treated with enoxaparin (for anti-coagulation). A DRESS syndrome developed after two weeks (RegiSCAR score = 7). Enoxaparin was considered the culprit drug and replaced with the fully synthetic LMWH fondaparinux. At the same time, high-dosage prednisone was added to the therapy. The DRESS slowly subsided and the patient survived. Upon recovery and corticosteroid washout, a lymphocyte proliferation test for both LMWHs was performed, yielding a positive response not only for enoxaparin but also for fondaparinux. Conclusions. By lymphocyte proliferation test we demonstrated that both enoxaparin and fondaparinux were implicated in this case of DRESS, occurring in an elderly COVID-19 patient. In retrospect, the choice of using a sustained high-dose corticosteroid treatment while maintaining anti-coagulation by fondaparinux proved to be right. Ultimately, the patient recovered from both DRESS and COVID-19.

Due to the high prevalence of obstructive sleep apnea (OSA), it is recommended to use in-laboratory polysomnography (PSG) or a home sleep apnea test (HSAT) in uncomplicated adult subjects at high risk of OSA. The aims of the present study were to compare a HSAT device, a wrist worn peripheral arterial tone signal device (WatchPAT™-200 [WP]) with PSG and respiratory polygraphy (RP) in a low-risk population of OSA. A total of 47 adult subjects at low risk of OSA were simultaneously examined with the three different approaches in a single night. The sleep studies were scored independently and in a blinded fashion, then the results and the parameters (Respiratory Disturbance Index, apnea-hypopnea index [AHI] and oxygen desaturation index of 3%) were compared with several statistical analyses. The agreement between the sleep tools and correlation for the assessed parameters were analysed and compared with Bland and Altman plots and Pearson's coefficient (WP versus PSG, r = 0.86). For the severity of OSA ranked according to PSG, the Cohen's k was 0.60 and 0.82 for WP and RP, respectively. Specificity was higher for RP compared to WP for identifying the presence of OSA (AHIPSG cut-off ≥5 events/hr: 0.85 versus 0.73), while was quite similar in identifying patients who were more likely to be treated (AHIPSG cut-off ≥15 events/hr: 0.94 versus 0.96). Assessing the costs and the simplicity of the examination, the results of our present study demonstrate the usefulness of WP compared to PSG, especially in screening and follow-up for the ability to exclude subjects from treatment with continuous positive airway pressure (AHI

Idiopathic pulmonary fibrosis (IPF) is a chronic debilitating fibrotic lung disease leading to respiratory failure and ultimately to death. Noninvasive biomarkers, for the early diagnosis, differential diagnosis, prognosis, and prediction of therapeutic response, are needed. Previous studies support a role for periostin in lung fibrosis. The aim of our study was to analyze periostin levels in the airways of patients with IPF and to investigate its role as a useful predictive biomarker of the disease. We enrolled 30 IPF patients and 5 control subjects. All subjects underwent all standard radiological, functional, and biological examinations for IPF diagnosis and staging and exhaled breath condensate (EBC) collection. Periostin was assessed by an enzyme-linked immunosorbent assay kit on EBC. Periostin was dosable in the EBC of all subjects enrolled. We found higher exhaled periostin levels in IPF patients than healthy controls (65.5 ± 23.5 pg/mL vs. 33 ± 21.4 pg/mL

Background: Extracellular vesicles (EVs) are secreted by cells from their membrane within circulation and body fluids. Knowledge of the involvement of EVs in pathogenesis of lung diseases is increasing. The present study aimed to evaluate the expression of exosomal surface epitopes in a cohort of idiopathic pulmonary fibrosis (IPF) patients followed in two Italian Referral Centres for Interstitial Lung Diseases, comparing them with a group of healthy volunteers. Materials and Methods: Ninety IPF patients (median age and interquartile range (IQR) 71 (66–75) years, 69 males) were selected retrospectively. Blood samples were obtained from patients before starting antifibrotic therapy. A MACSPlex Exosome Kit, human, (Miltenyi Biotec, Bergisch-Gladbach, Germany), to detect 37 exosomal surface epitopes, was used. Results: CD19, CD69, CD8, and CD86 were significantly higher in IPF patients than in controls (p = 0.0023, p = 0.0471, p = 0.0082, and p = 0.0143, respectively). CD42a was lower in IPF subjects than in controls (p = 0.0153), while CD209, Cd133/1, MCSP, and ROR1 were higher in IPF patients than in controls (p = 0.0007, p = 0.0050, p = 0.0139, and p = 0.0335, respectively). Kaplan–Meier survival analysis for IPF patients: for median values and a cut-off of 0.48 for CD25, the two subgroups showed a significant difference in survival rate (p = 0.0243, hazard ratio: 0.52 (95%CI 0.29–0.92), the same was true for CD8 (cut-off 1.53, p = 0.0309, hazard ratio: 1.39 (95%CI 0.75–2.53). Conclusion: Our multicenter study showed for the first time the expression of surface epitopes on EVs from IPF patients, providing interesting data on the communication signatures/exosomal profile in serum from IPF patients and new insights into the pathogenesis of the disease and a promising reliability in predicting mid-term survival of IPF patients.

Background and Objectives: The potential role of lung ultrasound (LUS) in characterizing lung involvement in Coronavirus disease 2019 (COVID-19) is still debated. The aim of the study was to estimate sensitivity of admission LUS for the detection of SARS-CoV-2 lung involvement using Chest-CT (Computed Tomography) as reference standard in order to assess LUS usefulness in ruling out COVID-19 pneumonia in the Emergency Department (ED). Methods: Eighty-two patients with confirmed COVID-19 and signs of lung involvement on Chest-CT were consecutively admitted to our hospital and recruited in the study. Chest-CT and LUS examination were concurrently performed within the first 6–12h from admission. Sensitivity of LUS was calculated using CT findings as a reference standard. Results: Global LUS sensitivity in detecting COVID-19 pulmonary lesions was 52%. LUS sensitivity ranged from 8% in case of focal and sporadic ground-glass opacities (mild disease), to 52% for a crazy-paving pattern (moderate disease) and up to 100% in case of extensive subpleural consolidations (severe disease), although LUS was not always able to detect all the consolidations assessed at Chest-CT. LUS sensitivity was higher in detecting a typical Chest-CT pattern (60%) and abnormalities showing a middle-lower zone predominance (79%). Conclusions: As admission LUS may result falsely negative in most cases, it should not be considered as a reliable imaging tool in ruling out COVID-19 pneumonia in patients presenting in ED. It may at least represent an expanded clinical evaluation that needs integration with other diagnostic tests (e.g., nasopharyngeal swab, Chest-CT).

Transthoracic ultrasound (TUS) is a readily available imaging tool that can provide a quick real-time evaluation. The aim of this preliminary study was to establish a complementary role for this imaging method in the approach of interstitial lung diseases (ILDs). TUS examination was performed in 43 consecutive patients with pulmonary fibrosis and TUS findings were compared with the corresponding high-resolution computed tomography (HRCT) scans. All patients showed a thickened hyperechoic pleural line, despite no difference between dominant HRCT patterns (ground glass, honeycombing, mixed pattern) being recorded (p > 0.05). However, pleural lines’ thickening showed a significant difference between different HRCT degree of fibrosis (p < 0.001) and a negative correlation with functional parameters. The presence of >3 B-lines and subpleural nodules was also assessed in a large number of patients, although they did not demonstrate any particular association with a specific HRCT finding or fibrotic degree. Results allow us to suggest a complementary role for TUS in facilitating an early diagnosis of ILD or helping to detect a possible disease progression or eventual complications during routine clinical practice (with pleural line measurements and subpleural nodules), although HRCT remains the gold standard in the definition of ILD pattern, disease extent and follow-up.

Background: Severe eosinophilic asthma decreases lung function and causes worsen symptoms, often forcing recurrent maintenance corticosteroid use. The aim of our real-life study was to evaluate the effectiveness of an add-on treatment with benralizumab in patients with severe eosinophilic asthma, paying particular attention to the impact on their quality of life (QoL).Materials and methods: In this prospective study, 10 outpatients with severe eosinophilic asthma were added-on with benralizumab and followed-up in our severe asthma clinic after 12 and 24 weeks. At each patient visit, pre-bronchodilator FEV1 and inflammatory markers were recorded. Variations in asthma symptoms control and QoL perception was assessed by validated questionnaires.Results: All the subjects experienced a marked reduction of nocturnal and diurnal symptoms over time and were able to stop using OCS, as documented by the improvement in Asthma control test (ACT) and Asthma Control Questionnaire score. Similarly, we recorded a statistically significant increase in patient’s QoL perception in EQ-VAS, EQ-5D-3L and Asthma Quality of Life Questionnaire (AQLQ) assessment (p < 0.05). Simultaneously we recorded a significant reduction in eosinophilic inflammation, an improvement in pre-bronchodilator FEV1. These results appear to be in line with those already obtained in the previous randomized controlled trials (RCTs).Conclusion: Our 24-weeks real life experience supports the effectiveness of an add-on treatment with benralizumab in reducing eosinophilic inflammation and OCS-use, increasing lung function and improving control of nocturnal and diurnal symptoms, as well as restoring severe asthma patients to a better QoL.

Background. The highly variable manifestation of the COVID-19 disease, from completely asymptomatic to fatal, is both a clinical and a public health issue. The criteria for discharge of hospitalized patients have been based so far on the negative result of Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) tests, but the persistence of viral fragments may exceed that of the integral virus by weeks. The aim of our study was to verify the clearance of the virus at viral culture in patients hospitalized for COVID-19 that have clinically recovered but are still positive on nasopharyngeal swab. Methods. The study was conducted in hospitalized patients with positive RT-PCR on nasopharyngeal swab. Patients included were from asymptomatic to severe cases and performed nasopharyngeal control swabbing on day 14 for asymptomatic patient or at least three days after remission of symptoms. RT-PCR positive specimens were sent to a biosafety level 3 laboratory for viral culture. Results. We performed a combined analysis of RT-PCR and a highly sensitive in vitro culture from 84 samples of hospitalized patients. The average age was 46 &plusmn, 20.29, and 40.5% of the subjects had radiologically confirmed pneumonia, with average PaO2 of 72.35 &plusmn, 12.12and P/F ratio of 315 &plusmn, 83.15. Ct values for the N gene were lower in the first swab than in the control one (p &lt, 0.001). The samples from 83 patients were negative at viral culture, and RT-PCR on the respective supernatants always confirmed the absence of viral growth. Conclusions. Our preliminary results demonstrate that patients clinically recovered for at least three days show the viral clearance at viral culture, and presumably they continued to not be contagious.

Raffaele Campisi,1 Claudia Crimi,1 Santi Nolasco,2 Bianca Beghè,3 Leonardo Antonicelli,4 Gabriella Guarnieri,5 Nicola Scichilone,6 Morena Porto,2 Luigi Macchia,7 Giulia Scioscia,8 Maria Pia Foschino Barbaro,8 Alberto Papi,9 Nunzio Crimi1,2 1Respiratory Medicine Unit, A.O.U. Policlinico “G. Rodolico -San Marco”, Catania, Italy; 2Department of Clinical and Experimental Medicine, Section of Respiratory Diseases, University of Catania, Catania, Italy; 3Respiratory Medicine Unit, Department of Medicine, University of Modena and Reggio Emilia, Modena, Italy; 4Allergy Unit, Department of Internal Medicine, Ancona University Hospital, Ancona, Italy; 5Department of Cardiac, Thoracic and Vascular Sciences, University-City Hospital of Padova, Padova, Italy; 6University of Palermo, PROMISE Department, University of Palermo, Palermo, Italy; 7Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari, Bari, Italy; 8Department of Medical and Surgical Sciences, Institute of Respiratory Diseases, University of Foggia, Foggia, Italy; 9Respiratory Medicine Unit, S. Anna University Hospital, Ferrara, ItalyCorrespondence: Claudia CrimiRespiratory Medicine Unit, A.O.U. Policlinico “G. Rodolico - San Marco”, Catania, ItalyEmail dott.claudiacrimi@gmail.comIntroduction: Dupilumab is a monoclonal antibody targeting IL-4Rα recently licensed for severe asthma (SA). A Named Patients Program (NPP) was created in Italy before its commercial availability for SA patients with no other available therapeutic options. We aimed to assess the real-world effectiveness of dupilumab in patients with SA and unmet needs.Methods: We performed a multicentre retrospective study, including SA patients admitted to the NPP treated with dupilumab for 12 months. Data on the number of exacerbations, Asthma Control Test (ACT), pre-bronchodilator FEV1%, oral corticosteroids (OCSs) use, FeNO and eosinophils count in peripheral blood were recorded at baseline and after 3, 6, and 12 months.Results: We included 18 SA patients (mean age 53.3± 12.4 years, 66.7% female). Eleven (61.1%) were OCSs dependent. Five patients (27.8%) received previous anti-IgE and/or anti-IL-5 agents. A significant improvement in ACT score (from 15.7± 5.1 to 18.8± 4.8, p=0.023), OCSs intake [10 (5– 25) mg/day to 0 (0– 5) mg/day, p=0.0333] and FeNO [from 25 (20– 80) ppb to 21 (10.9– 55.3) ppb, p=0.0190] was already detected after 3 months of treatment. After 12 months, a statistically significant decrease in the number of exacerbations from 2 (0– 3) to 0 (0– 1) (p< 0.0068) and increase in FEV1% from 73.5± 19.5% to 87.1± 19.2% (p=0.0407) and ACT to a mean value of 22.4± 1.7 (p< 0.0001) and the interruption of OCSs in all the patients (p< 0.0001) was observed. A transient increase in the eosinophil count was observed in five patients (above 1000 cells/μL in 2 cases) after 3 months, without any clinical effect.Conclusion: Dupilumab improved all the explored clinical outcomes after 12 months, and the transient hypereosinophilia did not modify treatment response. These real-world data confirm the results reported in randomized controlled trials and provide an important opportunity to characterize the clinical impact of the treatment in a non-trial setting. Further real-world studies with a larger cohort of patients are needed to confirm these findings.Keywords: severe asthma, Named Patient Program, oral corticosteroids, real-world, dupilumab

Sleep disorders have emerged as highly prevalent conditions, and along with improved understanding of such disorders, increased attention has gained the evidence that perturbation in sleep architecture and continuity may initiate, exacerbate, or modulate the phenotypic expression of multiple diseases including cancer. Furthermore, obstructive sleep apnea (OSA) has recently been implicated in increased incidence and more adverse prognosis of cancer in humans. This study was designed to confirm the high prevalence of OSA in human malignancies and assess its prognostic relevance in metastatic colorectal carcinomas (mCRCs). A prospective cohort of 52 subjects, affected by solid histologically confirmed metastatic malignancies, was analyzed, and among them, 29 mCRCs were studied for the prognostic role of OSA. OSA was diagnosed in 34.6% (18/52) of patients with a statistically significant difference in apnea-hyponea index between OSA and non-OSA subgroups (14.2 ± 12.2 vs. 2.1 ± 1.5, p < 0.01 ). Consistently, OSA was diagnosed in 34.5% (10/29) of mCRCs with lower rates of first-line therapy disease control in OSA compared to non-OSA patients (60% in OSA vs. 94.7% in non-OSA, p = 0.03 ). Of note, progression-free and overall survival rates were significantly shorter in OSA (respectively, 9 and 22 months) compared non-OSA (20 and 40 months) mCRC patients (HR = 2.63; 95% CI 0.88–7.84, p = 0.01 for PFS; HR = 3.93; 95% CI 1.13–13.73, p < 0.001 for OS). Finally, the multivariate analysis showed that OSA is an independent prognostic factor for PFS p = 0.0076 and OS p = 0.0017 in this cohort. Altogether, these data suggest that OSA is a potential clinical marker predictor of poor prognosis in patients with mCRC.

Background: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids, which worsen patients’ health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab to mepolizumab in patients eligible for both biologics, but not optimally controlled by omalizumab.Methods: We retrospectively enrolled uncontrolled severe asthmatic patients, referred to seven asthma clinics in Italy, who switched from omalizumab to mepolizumab during the last two years. Clinical, functional, and laboratory information included blood eosinophil count, asthma control test, spirometry, serum IgE, fractional exhaled nitric oxide, oral corticosteroids intake, use of controller and rescue drugs, exacerbations/hospitalizations, visits and diagnostic exams. Within the perspective of Italian National Health System, a pre- and post-mepolizumab 12-month standardized total cost per patient was calculated.Results: 33 patients were enrolled: 5 males and 28 females, mean age 57 years, mean disease onset 24 years. At omalizumab discontinuation, 88% were oral corticosteroids-dependent with annual mean rate of 4.0 clinically significant exacerbations, 0.30 exacerbations needing emergency room visits or hospitalization; absenteeism due to disease was 10.4 days per patient. Switch to mepolizumab improved all clinical outcomes, reducing total exacerbation rate (RR = 0.06, 95% CI 0.03 to 0.14), oral corticosteroids -dependent patients (OR = 0.02, 95% CI 0.005 to 0.08), and the number of lost working days because of uncontrolled disease (Δ = -7.9, 95% CI -11.2 to -4.6). Pulmonary function improved, as well as serum IgE, fractional exhaled nitric oxide and eosinophils decreased. Mean annual costs were € 12,239 for omalizumab and € 12,639 for mepolizumab (Δ = € 400, 95% CI -1,588 to 2,389); the increment due to drug therapy (+ € 1,581) was almost offset by savings regarding all other cost items (- € 1,181). Conclusions: Patients with severe eosinophilic asthma, not controlled by omalizumab, experienced comprehensive benefits in asthma control by switching to mepolizumab. These relevant improvements were burdened by only very slight increases in economic costs.

Background: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ quality of life and increased healthcare spending. Objectives: To assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics but not optimally controlled with OMA. Methods: Uncontrolled patients referred to 6 asthma clinics in south of Italy switched from OMA to MEP, were enrolled and followed-up to Jan 2020. Clinical information included blood eosinophil count, asthma control test (ACT), pulmonary function, IgE, exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, visits and exams. A 12-months standardized total cost per patient pre and post MEP was calculated in the perspective of Italian National Health System. Results: 33 patients were enrolled: 5 male, median age 59 years, disease onset 24 years. At OMA discontinuation, 89% were OCS-dependent with annual mean rate of 3.1 exacerbations. The switch to MEP reduced both exacerbation (-2.8) and OCS-dependent patients (-76%). Pulmonary function improved and both IgE, FENO and eosinophils serum decreased. Annual cost was €11,277 with OMA and €12,498 with MEP (p=0.2041), the increment due to biologic (+€1,673) was partially offset by the saving due to all other cost items (-€452). Conclusions: Patients with severe eosinophilic asthma not controlled by OMA experienced a clinically benefit in asthma control switching to MEP with a slight economic impact.

Severe eosinophilic asthma causes airways hyperresponsiveness, worsening symptoms and decreasing lung function, often forcing to recurrent or maintenance corticosteroids use and deeply conditioning patients quality of life (QoL). The aim of our study was to determine if and how an add-on treatment with benralizumab may improve the QoL of patients with severe eosinophilic asthma. 10 outpatients with severe eosinophilic asthma (7 female and 3 male, aged 54±8.8) were added-on with benralizumab and followed-up in our accredited outpatient clinic for severe asthma at 12 and 24 weeks. During each visit, QoL was assessed by Asthma Quality of Life Questionnaire (AQLQ), EuroQol-visual analogue scales (EQ-VAS) and EuroQol-5Dimensions-3Levels (EQ-3D-5L). Simultaneously with a significant reduction in eosinophilic inflammation, exacerbations, and gaining in pre-bronchodilator FEV1 and symptoms control, all the subjects enrolled experienced a marked improvement in AQLQ [from 3.65±0.56 (baseline) to 4.61±0.67 (12 weeks) (p=0.003) and to 5.17±0.87 (24 weeks) (p=0.0002)], that covered all of the four health domains (symptoms perception, activity limitation, emotional function and environmental stimuli) investigated (p Our real life experience confirms the effectiveness of benralizumab as an add-on treatment in restoring patients with severe eosinophilic asthma to a better QoL perception already after 12 weeks of treatment.

Background: High-resolution computed tomography (HRCT) is the gold standard in the diagnosis and follow-up of interstitial lung diseases (ILDs), however it is associated with high radiation exposure. Aim of the study: Since Transthoracic Ultrasound (TUS) is a safe radiation-free diagnostic procedure, the aim of this study was to establish a complementary role for this imaging method in the approach of ILDs. Methods: TUS examination was performed in 43 consecutive patients (32 males and 11 females, aged 70.77±8.32 years) with pulmonary fibrosis (28 UIP/IPF, 4 CPFE, 2 NSIP, 4 HP and 5 ILD waiting for diagnostic definition). Ultrasound findings were compared with the corresponding HRTC scans and the ultrasound thickness of the hyperechoic pleural was correlated with functional parameters, whose impairment indicates the severity of the lung disease. Results: All patients showed a thickening of the hyperechoic pleural line with no difference between dominant HRTC patterns (ground glass, honeycombing, mixed pattern) (p=NS) and between IPF patients with a different stage of disease assessed by the GAP index (p=NS). However we found a correlation between the thickness of the hyperechoic pleural line and the impairment in functional parameters (FVC%, DLCO%, meters traveled and Nadir value of SaO2% during 6mWT). Conclusion: TUS may be an useful complementary tool in the assessment of an early peripheral interstitium involvement in ILDs, essentially represented by the findings of a thickened and irregular hyperechoic pleural line and of subpleural nodules/cysts, although HRCT remains the gold standard in the definition of ILD pattern, disease’s extent and follow-up.

Background: Idiopathic Pulmonary Fibrosis (IPF) is a lung degenerative interstitial lung disease with poor prognosis and a bad quality of life once the diagnosis is made. In the last decade many features of the disease have been investigated to better understand the pathological steps that lead to the onset of the disease and, moreover, different types of biomarkers have been tested to find valid diagnostic, prognostic and therapy response predictive ones. In the complexity of IPF, a decisive boost has been given to microRNA investigation. Aim: We compared the expression of 5 miRNA (-21;-210;-26a;Let-7d;-16), which we suppose have a role in the pathogenesis of IPF: between 61 patients (51M; 68±6.33 ys; FVC 70,8±16%; DLCO 48±13) and 15 healthy control matched for age, with the aim of evaluating a possible different expression of it. Method: Starting from serum sample, the total RNA containing miRNA was extracted from exosomes, by using the classic technique of TRIzol reagent. The analysis was performed by western blot after retro transcription. The relative expression levels for the target miRNA were normalized against miR-222 and calculated using the comparative 2−DDCt method Result: Our study revealed let-7d (0.64 vs 3.84) and miR-16 (0.82 vs 3) were significative down-regulated (p value Conclusion: Our result shows that mi-RNA seems have a role in pathogenesis of IPF, in particular let-7d and -16, both knows as anti-fibrotic, were down regulated in patients with IPF. Those findings could help the individuation of previously unknown key players in the pathophysiology of IPF and, most interestingly, more specific target for the development of effective medications.

Background: considering high prevalence and burden of obstructive sleep apnoea (OSA), effective diagnostic and treatment strategies are needed to minimize the negative health impacts and to maximize cost–effectiveness (Lugo VM et al. PLoS ONE 14(10):e0224069). Aims: to compare the costs, in terms of health expenditure, of home Continuous Positive Airway Pressure (CPAP) titration with a telemedicine system with respect to a hospital procedure. Methods: we conducted a prospective study on 31 patients (pts) affected by moderate or severe OSA (AHI>15), matched for anthropometric and clinical parameters. They were divided into 2 groups: pts who underwent home CPAP titration using a telemedicine system (group A), and pts referred to an inpatient sleep lab titration (group B). For each group we evaluated costs related to the titration procedure. Variables were compared with Student’s T-Test. Results: 15 pts were included in group A and 16 pts in group B. For home CPAP titration we considered costs related to equipment (APAP device with a remote monitoring system and material replacements), procedures (polysomnography) and working hours dedicated to the pts by the medical staff involved, for a total of 294.12€ per patient. For hospital titration, the total cost per patient was calculated based on the Diagnosis-Related Group (DRG) number 73 (annex 1, decree of the Ministry of Health, 18 October 2012, Italian National Health Service) and it amounts to about 1186€. Comparison between the groups showed a net saving of 75% in the home CPAP titration group. Conclusions: telemedicine is a useful tool for OSA management, facilitating access to healthcare and reducing expenditures.

Background: Asthma severity differs according to gender, in adult women, there is higher prevalence and severity of asthma than in men, and it coincides with changes in sex hormones. Recently, a new phonotype of asthma has been identified that appears after menopause, and it may be associated with decreased estrogen levels. Our goal was to study the 17&beta, estradiol (E2) concentrations in the blood and airways of women affected by asthma onset after menopause, evaluating its possible role in the severity of the disease. Methods: We enrolled 33 consecutive women with a diagnosis of postmenopausal asthma, recruited from the outpatient pulmonary clinic: 18 with severe (SA) and 15 with mild-to-moderate (MMA) asthma. We also included 30 age-matched healthy menopausal women as controls (HS). All subjects enrolled underwent blood and sputum collection (IS), and E2 concentrations were determined in plasma and sputum supernatant samples using an enzyme-linked immunosorbent assay (ELISA) kit. Results: Significantly higher serum concentrations of E2 were found in postmenopausal SA compared to MMA and HS, respectively (33 &plusmn, 5.5 vs. 24 &plusmn, 6.63 vs. 7.79 &plusmn, 1.54 pg/mL, p &lt, 0.05). Similar results were found in the IS: significantly higher levels of E2 were detected in patients with postmenopausal SA compared with MMA and HS, respectively (0.34 &plusmn, 0.17 vs. 0.26 &plusmn, 0.13 vs. 0.07 &plusmn, 0.06 pg/mL, p &lt, 0.05). We found positive correlations between IS E2 concentrations and sputum neutrophil levels in SA group (&rho, = 0.52, p &lt, 0.05). Conclusions: Our findings showed the possibility to measure E2 in the airways, and it has increased in postmenopausal asthmatic patients, especially in those with SA. Airways E2 levels may serve as a suitable biomarker of postmenopausal SA to help to phenotype SA patients with neutrophil inflammation.

Obstructive sleep apnoea (OSA) syndrome, the most frequent sleep‐disordered breathing, is a comorbidity of asthma, whose prevalence covers about 49.5% of asthmatic adult patients. A 61‐year‐old female patient, affected by severe allergic asthma and obesity, started treatment with omalizumab and underwent polysomnography showing a severe OSA pattern (apnoea/hypopnoea index (AHI): 72.7). After six months, she showed functional improvement and good asthma symptoms control and underwent a new polygraphy for the persistence of the night symptoms which showed an ameliorated, despite still severe, OSA pattern (AHI: 31.9). The patient obtained complete polygraphic normalization after adequate positive airway pressure (PAP) titration. While bronchodilator efficacy in chronic obstructive pulmonary disease (COPD)/OSA overlap syndrome has been proven in raising nocturnal oxygen saturation, there is no such evidence about biological therapy in patients affected by severe asthma and OSA. This is the first documented case report that demonstrates a possible role of omalizumab in improving the OSA pattern in a patient affected by severe asthma and OSA., We report the case of a 61‐year‐old severe allergic asthmatic woman (body mass index (BMI): 38) who was followed up by our outpatient clinic for one year. She started treatment with omalizumab and underwent polysomnography showing a severe obstructive sleep apnoea (OSA) pattern (apnoea/hypopnoea index (AHI): 72.7). After six months, she showed functional improvement and good asthma symptoms control and underwent a new polygraphy for the persistence of the night symptoms which showed an ameliorated, despite still severe, OSA pattern (AHI: 31.9). The patient obtained complete polygraphic normalization after adequate positive airway pressure (PAP) titration. This is the first documented case report that demonstrates a possible role of omalizumab in improving the OSA pattern in a patient affected by severe asthma and OSA.

Background: Adherence to medications is crucial in patients with severe asthma in light of the negative clinical impact and costs of non-adherence. Adherence to omalizumab has not been well studied in real-world settings. The aim of this study was to assess adherence to omalizumab and evaluate treatment effectiveness in relation to adherence. Methods: This was a retrospective, observational, and multicenter real-world study. Omalizumab dose, timing of administration, and duration of treatment ( 4 years) were analyzed. Adherence was evaluated by examining rates of expected and missing doses. Good adherence (10% doses missed) were determined. For effectiveness in relation to adherence of omalizumab we considered asthma exacerbations, hospitalizations, asthma control test (ACT), and Forced Expiratory Volume in 1 s (FEV1). Results: A total of 196 patients were evaluated, and 161 were suitable for data analyses. Good adherence was shown in 90.7% of patients and poor adherence in 9.3%. Considering adherence in relation to treatment duration: 4 years, 100% were adherent (expected doses, 6120; missed doses, none). Indices of efficacy between pre- and post-treatment showed significant improvement (p