Severe Asthma In Adults Research Articles

T2-low severe asthma clinical spectrum and impact: The Greek PHOLLOW cross-sectional study.

Data on type 2 (T2)-low severe asthma (SA) frequency is scarce, resulting in an undefined unmet therapeutic need in this patient population. Our objective was to assess the frequency and characterize the profile and burden of T2-low SA in Greece. PHOLLOW was a cross-sectional study of adult SA patients. Based on a novel proposed classification system, patients were classified as T2-low if blood eosinophil count (BEC; cells/μL) was <150, fractional exhaled nitric oxide (FeNO)<25 ppb and any allergy status or BEC < 150/FeNO < 50 ppb/no allergy or BEC < 300/FeNO < 25 ppb/no allergy. For patients receiving biologics and/or oral corticosteroids, only those with BEC < 150/FeNO < 25 ppb/no allergy/no response to therapy were classified as T2-low. Secondary outcome measures were: Asthma Control Test (ACTTM), Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), hospital anxiety and depression scale (HADS), and Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire. From 22-Mar-2022 to 15-Mar-2023, 602 eligible SA patients were enrolled. The frequency of T2-low asthma was 20.1%. Of those, 71.1% had experienced ≥1 clinically significant exacerbations in the past year, 62.8% had ACT score <20 (uncontrolled asthma), and 22.3% were biologic-treated. Mini-AQLQ score was <6 (impairment) in 79.5% of patients, HADS-total score was ≥15 (clinically significant emotional distress) in 43.8%, while median percent activity impairment and work productivity loss were 30.0 for both domains. Clinical and patient-reported outcomes were worse among patients with ACT-defined uncontrolled asthma. One-fifth of SA patients present with a T2-low endotype. These patients frequently have uncontrolled disease and experience impairments in their quality of life, emotions and work ability.

Efficacy and safety of magnesium sulfate in the treatment of adult patients with acute severe asthma: a Meta-analysis

To evaluate the efficacy and safety of magnesium sulfate in the treatment of acute severe asthma in adults. Literature searches were conducted on PubMed, Cochrane, CNKI, VIP and Wanfang databases to screen randomized controlled trial (RCT) of magnesium sulfate in the treatment of acute severe asthma in adults, starting from the establishment of the database and ending on May 22, 2024. The control group received conventional treatment. The observation group was given intravenous magnesium sulfate on the basis of routine treatment. The outcome indexes included total effective rate, peak expiratory flow (PEF), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and other pulmonary function indexes, and incidence of adverse reactions. The selection of relevant literature, the collection of data needed for the study and the risk assessment of bias in the included study were all conducted independently by 2 researchers. Stata 12.0 software was used for Meta-analysis, and funnel plot was used to evaluate publication bias. Sixteen RCT studies with a total of 2 601 patients were included. Meta-analysis results showed that the total effective rate in the observation group was significantly higher than that in the control group [risk ratio (RR) = 1.11, 95% confidence interval (95%CI) was 1.03-1.20, P = 0.008]. In pulmonary function examination, PEF [weighted mean difference (WMD) = 0.70, 95%CI was 0.24-1.15, P = 0.003], FEV1 (WMD = 0.48, 95%CI was 0.29-0.68, P = 0.000) and FVC (WMD = 0.72, 95%CI was 0.47-0.97, P = 0.000) were significantly better than those in the control group. There was no significantly difference in the incidence of adverse reactions between the two groups (RR = 0.51, 95%CI was 0.17-1.55, P = 0.419). The funnel plot was drawn for the total effective rate, which showed that each study presented a symmetrical distribution, and the Begg's test (Z = 1.31, P = 0.189) and Egger's test (t = 1.18, P = 0.261) were combined to consider the small possibility of publication bias. Current evidence shows that the use of magnesium sulfate in the treatment of acute severe asthma in adults increases the total response rate and improves lung function without increasing the incidence of adverse reactions. Due to the limited number and quality of included studies, the above conclusions need to be verified by more high-quality studies high-quality studies.

The role of type 2 diabetes in the severity of adult asthma.

This review summarizes recent basic, translational, and clinical research on type 2 diabetes (T2D) and its relationship with asthma severity in the context of T2D mechanisms and asthma outcomes. Several clinical asthma outcomes, such as lung function and exacerbations, demonstrate a strong association between T2D and asthma and support that T2D contributes to worse asthma outcomes. Multiple mechanisms underlying those observed associations, and their representative biomarkers, have been proposed. However, prospective, controlled human studies in the context of both T2D and asthma are limited. T2D is associated with worse asthma outcomes and more severe asthma. Yet patients with more severe or uncontrolled asthma are also at a higher risk for systemic steroid exposure, which worsens glycemic control and metabolic dysregulation. Preclinical and translational studies point to metabolic dysregulation as a driver of airway inflammation. Addressing these metabolic pathways through T2D treatment may, in turn, directly or indirectly improve clinical asthma outcomes. While additional research is needed to identify biomarkers of risk and treatment response in metabolic asthma, this review highlights the importance of considering T2D as a clinically relevant asthma comorbidity.

Patient-centred composite scores as tools for assesment of response to biological therapy for paediatric and adult severe asthma.

We have previously developed Core Outcome Measures sets for Severe Asthma (COMSA) by multi-stakeholder consensus. There are no patient-centred tools to quantify response to biologics for severe asthma. We aimed to develop paediatric and adult CompOsite iNdexes For Response in asthMa (CONFiRM) incorporating clinical parameters and patient-reported quality of life (QoL). International expert healthcare professionals (HCPs) and patients with severe asthma were invited to: 1) develop consensus levels of clinically relevant changes for each outcome measure within COMSA; 2) use multicriteria decision analysis to develop the CONFiRM scores and 3) assess their internal validity. A separate group of HCPs evaluated CONFiRM's external validity. Five levels of change for each COMSA outcome were agreed. Severe exacerbations and maintenance oral corticosteroids use were rated as most important in determining both paediatric and adult CONFiRM scores. There was strong agreement between HCPs and patients, although patients assigned greater importance to QoL. The CONFiRM score quantified response to a biological from -31 (deterioration) to 69 (best possible response). Paediatric and adult CONFiRMs had good discriminative ability for a sufficient (AUC≥0.92) and a substantial (AUC≥0.95) response to biologics. Both CONFiRMs demonstrated excellent external validity (Spearman correlation coefficients 0.9 and 0.8 for paediatric and adult respectively (p<0.0001)). We have developed novel patient-centred paediatric and adult CONFiRMs which include QoL measures. CONFiRMs should allow a more holistic understanding of response for the patient and a standardised assessment of the effectiveness of biologics between studies. Further research is needed to prospectively validate CONFiRM scores.

The Belgian IgE study: Staphylococcus aureus toxins in adult severe asthma

The Belgian IgE study: Staphylococcus aureus toxins in adult severe asthma

Species-level, metagenomic and proteomic analysis of microbe-immune interactions in severe asthma.

The airway microbiome in severe asthma has not been characterised at species-level by metagenomic sequencing, nor have the relationships between specific species and mucosal immune responses in 'type-2 low', neutrophilic asthma been defined. We performed an integrated species-level metagenomic data with inflammatory mediators to characterise prevalence of dominant potentially pathogenic organisms and host immune responses. Sputum and nasal lavage samples were analysed using long-read metagenomic sequencing with Nanopore and qPCR in two cross-sectional adult severe asthma cohorts, Wessex (n = 66) and Oxford (n = 30). We integrated species-level data with clinical parameters and 39 selected airway proteins measured by immunoassay and O-link. The sputum microbiome in health and mild asthma displayed comparable microbial diversity. By contrast, 23% (19/81) of severe asthma microbiomes were dominated by a single respiratory pathogen, namely H. influenzae (n = 10), M. catarrhalis (n = 4), S. pneumoniae (n = 4) and P. aeruginosa (n = 1). Neutrophilic asthma was associated with H. influenzae, M. catarrhalis, S. pneumoniae and T. whipplei with elevated type-1 cytokines and proteases; eosinophilic asthma with higher M. catarrhalis, but lower H. influenzae, and S. pneumoniae abundance. H. influenzae load correlated with Eosinophil Cationic Protein, elastase and IL-10. R. mucilaginosa associated positively with IL-6 and negatively with FGF. Bayesian network analysis also revealed close and distinct relationships of H. influenzae and M. catarrhalis with type-1 airway inflammation. The microbiomes and cytokine milieu were distinct between upper and lower airways. This species-level integrated analysis reveals central, but distinct associations between potentially pathogenic bacteria and airways inflammation in severe asthma.

Association of Obesity and Severe Asthma in Adults.

The incidence of obesity and asthma continues to enhance, significantly impacting global public health. Adipose tissue is an organ that secretes hormones and cytokines, causes meta-inflammation, and contributes to the intensification of bronchial hyperreactivity, oxidative stress, and consequently affects the different phenotypes of asthma in obese people. As body weight increases, the risk of severe asthma increases, as well as more frequent exacerbations requiring the use of glucocorticoids and hospitalization, which consequently leads to a deterioration of the quality of life. This review discusses the relationship between obesity and severe asthma, the underlying molecular mechanisms, changes in respiratory function tests in obese people, its impact on the occurrence of comorbidities, and consequently, a different response to conventional asthma treatment. The article also reviews research on possible future therapies for severe asthma. The manuscript is a narrative review of clinical trials in severe asthma and comorbid obesity. The articles were found in the PubMed database using the keywords asthma and obesity. Studies on severe asthma were then selected for inclusion in the article. The sections: 'The classification connected with asthma and obesity', 'Obesity-related changes in pulmonary functional tests', and 'Obesity and inflammation', include studies on subjects without asthma or non-severe asthma, which, according to the authors, familiarize the reader with the pathophysiology of obesity-related asthma.

Unraveling the Molecular Landscape of Neutrophil Extracellular Traps in Severe Asthma: Identification of Biomarkers and Molecular Clusters.

Neutrophil extracellular traps (NETs) play a central role in chronic airway diseases. However, the precise genetic basis linking NETs to the development of severe asthma remains elusive. This study aims to unravel the molecular characterization of NET-related genes (NRGs) in severe asthma and to reliably identify relevant molecular clusters and biomarkers. We analyzed RNA-seq data from the Gene Expression Omnibus database. Interaction analysis revealed fifty differentially expressed NRGs (DE-NRGs). Subsequently, the non-negative matrix factorization algorithm categorized samples from severe asthma patients. A machine learning algorithm then identified core NRGs that were highly associated with severe asthma. DE-NRGs were correlated and subjected to protein-protein interaction analysis. Unsupervised consensus clustering of the core gene expression profiles delineated two distinct clusters (C1 and C2) characterizing severe asthma. Functional enrichment highlighted immune-related pathways in the C2 cluster. Core gene selection included the Boruta algorithm, support vector machine, and least absolute contraction and selection operator algorithms. Diagnostic performance was assessed by receiver operating characteristic curves. This study addresses the molecular characterization of NRGs in adult severe asthma, revealing distinct clusters based on DE-NRGs. Potential biomarkers (TIMP1 and NFIL3) were identified that may be important for early diagnosis and treatment of severe asthma.

Valuing a Reduction in the Risk and Severity of Asthma: A Large Scale Multi-Country Stated Preference Approach

Abstract Asthma is a non-communicable and non-curable lung disease that affects 10% of children and 4% of adults worldwide and is associated with an array of environmental contaminants and chemicals. This article offers values suitable for use in cost–benefit analyses of the willingness to pay (WTP) for reduced severity of asthma in adults and children and in reduced probability of getting asthma for these two population groups, all in the context of reducing chemical exposures. To this end, an online survey was administered between November 2021 and May 2022 to 12 727 respondents from seven countries of the Organisation for Economic Co-operation and Development (OECD). This article applies two stated preference methods for eliciting WTP: the contingent valuation method for reduced asthma severity and choice experiments for reduced probability of getting asthma of various severities. The context for such elicitations was a set of household products that contain fewer hazardous chemicals than what is currently available in supermarkets but are more expensive. The study finds that the WTP for reducing asthma severity in adults by one step, e.g. from “moderate plus” to “moderate”, is USD2022 529 per year on average. The parental WTP for reducing asthma severity in their children is USD2022 PPP 948 per year and is on average 1.8 times higher than their WTP for themselves. The mean value of a statistical case (VSC) of adult asthma which would be applied to predictions of new cases of asthma avoided by a regulation equals USD2022 280 000, while the mean VSC of childhood asthma equals USD2022 430 000.

Biomarker Predictors of Clinical Efficacy of the Anti-IgE Biologic Omalizumab in Severe Asthma in Adults: Results of the SoMOSA Study.

Background: The anti-IgE monoclonal antibody omalizumab is widely used for severe asthma. This study aimed to identify biomarkers that predict clinical improvement during 1 year of omalizumab treatment. Methods: One-year open-label Study of Mechanisms of action of Omalizumab in Severe Asthma (SoMOSA) involving 216 patients with severe (Global Initiative for Asthma step 4/5) uncontrolled atopic asthma (at least two severe exacerbations in the previous year) taking high-dose inhaled corticosteroids and long-acting β-agonists with or without maintenance oral corticosteroids. It had two phases: 0-16 weeks, to assess early clinical improvement by Global Evaluation of Therapeutic Effectiveness (GETE); and 16-52 weeks, to assess late responses based on ⩾50% reduction in exacerbations or mOCS dose. All participants provided samples (exhaled breath, blood, sputum, urine) before and after 16 weeks of omalizumab treatment. Measurements and Main Results: A total of 191 patients completed phase 1; 63% had early improvement. Of 173 who completed phase 2, 69% had reduced exacerbations by ⩾50% and 57% (37 of 65) taking mOCSs had reduced their dose by ⩾50%. The primary outcomes 2,3-dinor-11-β-PGF2α, GETE score, and standard clinical biomarkers (blood and sputum eosinophils, exhaled nitric oxide, serum IgE) did not predict either clinical response. Five volatile organic compounds and five plasma lipid biomarkers strongly predicted the ⩾50% reduction in exacerbations (receiver operating characteristic areas under the curve of 0.780 and 0.922, respectively) and early responses (areas under the curve of 0.835 and 0.949, respectively). In an independent cohort, gas chromatography/mass spectrometry biomarkers differentiated between severe and mild asthma. Conclusions: This is the first discovery of omics biomarkers that predict improvement in asthma with biologic agent treatment. Prospective validation and development for clinical use is justified.

Obstructive Sleep Apnea: a risk for uncontrolled and more severe asthma in adults that we should keep an eye on.

Background. Asthma control can be influenced by several factors, including obstructive sleep apnea (OSA). The literature reports variable prevalence and magnitude of OSA impact on asthma outcomes. The aim of our study is to analyze the frequency of high-risk for OSA in asthma patients and its impact on disease severity and control. Methods. We conducted a cross-sectional study at an Allergy Department with adult asthma patients recruited while undergoing routine lung function tests. Data on sex, age, body mass index, allergen sensitization, smoking habits, risk of OSA (using the Berlin questionnaire), rhinitis control (through CARAT), asthma severity (based on GINA 2023), asthma control (using the ACT), adherence to asthma treatment (through Treatment Adherence Measure) and pulmonary function test results were collected. Results. We included 216 patients, predominantly women (70.4%), with a median (P25-P75) age of 29.0 (21.0-45.0) years, of whom 28.2% were on GINA treatment levels 4-5. In 75.5% of cases asthma was controlled. High-risk for OSA was identified in 21.8% of patients. Asthma patients with high-risk for OSA were more likely to have uncontrolled [(47.8%; n = 22) vs (15.8%; n = 26); p less than 0.001] and more severe disease [(44.7%; n = 21) vs (23.7%; n = 40), p = 0.006]. In multivariable analysis, high-risk for OSA (OR 2.81 [95%CI 1.1.28-6.17], p = 0.010), sex (women) (OR 5.21 [95% CI 1.70-15.96], p = 0.004), uncontrolled rhinitis (OR 3.65 [95%CI 1.38-9.64], p = 0.009) and GINA asthma treatment steps 4-5 (OR 2.46 [95%CI 1.15-5.26], p = 0.020) were associated with uncontrolled asthma. Conclusions. It is crucial to actively investigate OSA, especially in patients with uncontrolled and more severe forms of asthma.

Adult Severe Asthma Registries: A Global and Growing Inventory.

The International Severe Asthma Registry (ISAR; http://isaregistries.org/) uses standardised variables to enable multi-country and adequately powered research in severe asthma. This study aims to look at the data countries within ISAR and non-ISAR countries reported collecting that enable global research that support individual country interests. Registries were identified by online searches and approaching severe asthma experts. Participating registries provided data collection specifications or confirmed variables collected. Core variables (results from ISAR's Delphi study), steroid-related comorbidity variables, biologic safety variables (serious infection, anaphylaxis, and cancer), COVID-19 variables and additional variables (not belonging to the aforementioned categories) that registries reported collecting were summarised. Of the 37 registries identified, 26 were ISAR affiliates and 11 non-ISAR affiliates. Twenty-five ISAR-registries and 4 non-ISAR registries reported collecting >90% of the 65 core variables. Twenty-three registries reported collecting all optional steroid-related comorbidity variables. Twenty-nine registries reported collecting all optional safety variables. Ten registries reported collecting COVID-19 variables. Twenty-four registries reported collecting additional variables including data from asthma questionnaires (10 Asthma Control Questionnaire, 20 Asthma Control Test, 11 Asthma Quality of Life Questionnaire, and 4 EuroQol 5-dimension 5-level Questionnaire). Eight registries are linked to databases such as electronic medical records and national claims or disease databases. Standardised data collection has enabled individual severe asthma registries to collect unified data and increase statistical power for severe asthma research irrespective of ISAR affiliations.

Biologics in severe asthma: A pragmatic approach for choosing the right treatment for the right patient

The development of monoclonal antibody therapies targeting specific components of the pathways relevant to asthma pathophysiology has revolutionized treatment of severe asthma both in adults and children and helped to further unravel the heterogeneity of this disease. However, the availability of multiple agents, often with overlapping eligibility criteria, creates a need for pragmatic guidance for specialists undertaking care of patients with severe asthma. In this review, we provide an overview of the data supporting the clinical efficacy of biologics in distinct asthma phenotypes/endotypes. We also focus on the role of biomarkers and treatable traits, including comorbidities, in the choice of asthma biologics, highlight which treatments have been demonstrated to be steroid sparing in corticosteroid dependent asthma, and provide practical guidance that can drive shared decision making on treatment choice with patients. In addition, we summarize what is known to date regarding long-term safety of these drugs, and lastly, discuss future directions in biologics research.

Tropical high altitude and severe asthma in adults: house dust mite sensitization and phenotypic distribution

Background There is a lack of information on house dust mite (HDM) sensitization and phenotype distribution in patients with severe asthma (SA) living permanently at high-altitude (HA) in tropical regions, which may be different. Objective The aim of this study was to characterize adults with SA in a tropical high altitude city (2,640 m): Bogotá, Colombia. Material and Methods This observational cross-sectional study included severe asthmatic outpatients (n = 129) referred to the ASMAIRE program of the Fundación Neumológica Colombiana in Bogotá (2,640 m). Clinical history, spirometry, total IgE, blood eosinophils, and skin prick test (SPT), including HDM allergens, were performed. Phenotype definitions: Allergic/atopic (AA): IgE ≥100 IU/mL and/or at least one positive SPT; eosinophilic (EOS): blood eosinophils ≥300 cells/µL; type 2-high: AA and/or EOS phenotype; type 2-low: non-AA/non-EOS phenotype (IgE <100 IU/mL, negative SPT, and blood eosinophils <300 cells/µL). Results A total of 129 adults with SA were included, 79.8% female. Phenotype distribution: AA: 61.2%; EOS: 37.2%; type 2-high: 72.1%; type 2-low: 27.9%. Among AA patients, HDM sensitization was present in 87% and 34.9% were non-eosinophilic. There was a significant overlap between the phenotypes. Conclusions In contrast to non-tropical high-altitude regions, we found a high frequency of HDM sensitization in patients with AA phenotype living in a tropical high-altitude city. We also found a discrete lower frequency of EOS phenotype with no other significant differences in the phenotypic distribution compared to that described at low altitudes. We propose that tropical location may modify the effect of high altitude on HDM concentrations and allergenicity.

Response to Biologics and Clinical Remission in the Adult German Asthma Net Severe Asthma Registry Cohort.

Recently, criteria for evaluation of response to biologics have been proposed and the concept of clinical remission has gained attention as a possible goal even in severe asthma. To analyze the response and remission in the German Asthma Net severe asthma registry cohort. We included adults not using a biologic at baseline (V0) and compared patients treated between V0 and 1-year visit (V1) without using a biologic (group A) to patients starting with a biologic after V0 and continuing it up to V1 (group B). We applied the Biologics Asthma Response Score to quantify composite response in good, intermediate, or insufficient. We defined clinical remission (R) as absence of significant symptoms (Asthma Control Test score ≥ 20 at V1) in the absence of exacerbations and oral corticosteroid therapy. Group A included 233 and group B 210 patients, the latter receiving omalizumab (n= 33), mepolizumab (n= 40), benralizumab (n= 81), reslizumab (n= 1), or dupilumab (n= 56). At baseline, group B had less often an allergic phenotype (35.2% vs 41.6%), lower Asthma Control Test score (median, 12 vs 14), more exacerbations in the past year (median, 3 vs 2), and more often high-dose inhaled corticosteroid treatment (71.4% vs 51.5%) than group A. After 1 year of treatment, rates of response (good: 61.4% vs 34.8%; intermediate: 26.7% vs 42.9%; insufficient: 11.9% vs. 22.3%) and/or clinical remission (37.6% vs 17.2%) were higher in group B than in group A. Despite more severe asthma at baseline, patients treated with biologics had a markedly higher probability of achieving good clinical response and/or remission than patients treated without biologics.

Prevalence and management of severe asthma in the Nordic countries: findings from the NORDSTAR cohort.

Real-life evidence on prevalence and management of severe asthma is limited. Nationwide population registries across the Nordic countries provide unique opportunities to describe prevalence and management patterns of severe asthma at population level. In nationwide register data from Sweden, Norway and Finland, we examined the prevalence of severe asthma and the proportion of severe asthma patients being managed in specialist care. This is a cross-sectional study based on the Nordic Dataset for Asthma Research (NORDSTAR) research collaboration platform. We identified patients with severe asthma in adults (aged ≥18 years) and in children (aged 6-17 years) in 2018 according to the European Respiratory Society/American Thoracic Society definition. Patients managed in specialist care were those with an asthma-related specialist outpatient contact (only available in Sweden and Finland). Overall, we identified 598 242 patients with current asthma in Sweden, Norway and Finland in 2018. Among those, the prevalence of severe asthma was 3.5%, 5.4% and 5.2% in adults and 0.4%, 1.0%, and 0.3% in children in Sweden, Norway and Finland, respectively. In Sweden and Finland, 37% and 40% of adult patients with severe asthma and two or more exacerbations, respectively, were managed in specialist care; in children the numbers were 56% and 41%, respectively. In three Nordic countries, population-based nationwide data demonstrated similar prevalence of severe asthma. In children, severe asthma was a rare condition. Notably, a large proportion of patients with severe asthma were not managed by a respiratory specialist, suggesting the need for increased recognition of severe asthma in primary care.

Bronchial eosinophils, neutrophils, and CD8 + T cells influence asthma control and lung function in schoolchildren and adolescents with severe treatment-resistant asthma

Studies in adult severe treatment-resistant asthma (STRA) have demonstrated heterogeneous pathophysiology. Studies in the pediatric age group are still scarce, and few include bronchial tissue analysis. We investigated 6-18-year-old patients diagnosed with STRA in Sao Paulo, Brazil, by characterizing the different lung compartments and their correlations with asthma control and lung function. Inflammatory profiles of 13 patients with a confirmed diagnosis of STRA were analyzed using blood, induced sputum, bronchoalveolar lavage, viral and bacterial screens and endobronchial biopsy. Inflammatory cells, cytokines, and basement membrane thickening were tested for correlations with the asthma control test (ACT) and spirometry and plethysmography parameters. Endobronchial biopsy specimens from 11 patients were viable for analysis. All biopsies showed eosinophilic infiltration. Submucosal (SM) eosinophils and neutrophils were correlated with worse lung function (pre-BD FEV1), and SM neutrophils were correlated with fixed obstruction (post-BD FEV1). Intraepithelial (IE) neutrophils were positively correlated with lung function (pre-BD sGaw). CD8 + T cells had the highest density in the IE and SM layers and were positively correlated with ACT and negatively correlated with the cytokines IL1β, IL2, IL5, IL7, IL10, IL12, IL17, GCSF, MCP-1, INF-δ, and TNFα in sputum supernatant. The ASM chymase + mast cell density correlated positively with quality-of-life score (pAQLQ) and ACT. Eosinophils and SM neutrophils correlated with worse lung function, while IE neutrophils correlated with better lung function. Most importantly, CD8 + T cells were abundant in bronchial biopsies of STRA patients and showed protective associations, as did chymase + mast cells.

EE6 Economic Burden of Severe Asthma in Adults and Children Treated With Omalizumab From 2012 to 2019

Uncontrolled asthma is a condition associated with high morbidity and healthcare costs. We described healthcare resource use (HCRU) and related costs in asthma adults and children treated with omalizumab (OMA) before and after OMA initiation (T0).

Correct treatment regimen and inhalation technique are the components of success in bronchial asthma in the era of COVID-19

The goal of Asthma treatment is to achieve a controlled condition, that is, to minimize the burden of symptoms and the risk of exacerbations. Many factors hinder the achievement of this goal: non-compliance with recommendations for drug therapy, the influence of concomitant diseases, the impact of triggers, low patient adherence to prescribed treatment, violation of inhalation technique. In general, there is no significant difference in the risk of hospitalization or mortality due to COVID-19 in patients with Asthma. At the same time, studies show that non-allergic Asthma, severe Asthma, Asthma in combination with obesity, lack of adequate basic therapy can create the greatest risk of infection and severe clinical outcomes of COVID-19. Asthma can be a predictor of a prolonged intubation period in severe respiratory failure during COVID-19, especially in people younger than 65 years. GINA experts agree that during a pandemic, it is especially important that patients with Asthma continue taking basic therapy, including inhaled corticosteroids (ICS), as prescribed by the recommendations. ICS therapy in combination with long-acting β2-agonists (LABA) is the main pharmacological method of treating moderate and severe Asthma in adolescents and adults. A single inhaler regimen with the use of a combination of ICS/formoterol is associated with a lower risk of severe exacerbations compared with supportive treatment of ICS/LABA in combination with SABA on demand. Studies show that the technique of inhalation maneuver can significantly affect the success of therapy. A wide variety of DPI causes problems with the choice and use by patients.

Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA).

Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) working group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies. COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult, and paediatric clinicians, pharmaceutical representatives and health regulators from across Europe. Evidence included a systematic review of development, validity, and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients' and carers' views about outcome measures. It was discussed using a modified GRADE Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria. Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV1) as z scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire, and Asthma Control Test (ACT) or Childhood-ACT while the adult COM includes the Severe Asthma Questionnaire and the Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately). This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.