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Real-world evidence is important to help unravel unanswered problems in severe asthma and is valuable to better understand the patient experience and common clinical practice. The Severe Heterogeneous Asthma Registry, Patient-centred (SHARP) Clinical Research Collaboration is created as a network of national registries and severe asthma centres that work together to perform registry based real-world research and clinical studies on a pan-European scale. Such collaboration requires a new, innovative design to overcome the many issues that arise with large-scale data collection across national borders. SHARP has developed a platform that offers a federated analysis approach where national registry data are transformed and integrated into a common data model (CDM). The CDM then allows a local analysis of de-identified patient data and subsequent aggregate (meta-)analysis. To facilitate an easily accessible way to set up new registries, SHARP enables new registries to take part in a central database, based on already proven technology. Next to being economical, this linkage ensures data from different SHARP central members to be comparable. Technological advancements lead to an ever-expanding rate of patient data that will be collected; with the collective effort of the pan-European severe asthma research community SHARP hopes to ensure that they are well equipped to enter a new era of medical research, with the ultimate goal to positively impact the lives of patients with severe asthma., Competing Interests: Conflict of interest: J.J.M.H. van Bragt has nothing to disclose. Conflict of interest: S. Hansen has nothing to disclose. Conflict of interest: R. Djukanovic reports receiving fees for lectures at symposia organised by Novartis, AstraZeneca and TEVA, consultation for TEVA and Novartis as member of advisory boards, and participation in a scientific discussion about asthma organised by GlaxoSmithKline. He is a co-founder and current consultant, and has shares in Synairgen, a University of Southampton spin out company. Conflict of interest: E.H.D. Bel reports grants and personal fees from GlaxoSmithKline, AstraZeneca, Novartis and Teva, and personal fees from Sanofi/Regeneron, Sterna and Chiesi, outside the submitted work. Conflict of interest: A. ten Brinke reports grants outside the submitted work from AstraZeneca, GSK and TEVA, institutional fees from Lectures from AstraZeneca, GSK, TEVA and Sanofi, and institutional fees from Research Advisory Boards from GSK, Sanofi, TEVA and AstraZeneca. Conflict of interest: S.S. Wagers reports consulting fees for work done on the SHARP project from the European Respiratory Society (ERS); and consulting fees from Kings College Hospital NHS Foundation Trust, Academic Medical Research, AMC Medical Research BV, Asthma UK, Athens Medical School, Boehringer Ingelheim International GmbH, CHU de Toulouse, CIRO, DS Biologicals Ltd, École Polytechnique Fédérale de Lausanne, ERS, FISEVI, Fluidic Analytics Ltd, Fraunhofer IGB, Fraunhofer ITEM, GlaxoSmithKline Research & Development Ltd, Holland & Knight, Karolinska Institutet Fakturor, KU Leuven, Longfonds, the National Heart & Lung Institute, Novartis Pharma AG, Owlstone Medical Limited, PExA AB, UCB Biopharma SPRL, UCB Biosciences GmbH, Umeå University, University Hospitals Southampton NHS Foundation Trust, Università Campus Bio-Medico di Roma, Universita Cattolica Del Sacro Cuore, Universität Ulm, the University of Bern, the University of Edinburgh, the University of Hull, the University of Leicester, the University of Loughborough, the University of Luxembourg, the University of Manchester, the University of Notthingham, Vlaams Brabant, Dienst Europa, Imperial College London, Boehringer Ingelheim, Breathomix, Gossamer Bio, AstraZeneca, CIBER, OncoRadiomics, the University of Leiden, the University of Wurzburg, Chiesi Pharmaceutical, the University of Liege, Teva Pharmacauticals and Sanofi, outside the submitted work. Conflict of interest: A.H. Maitland-van der Zee has received research grants outside the submitted work from GSK, Boehringer Ingelheim and Vertex, she is the PI of a P4O2 (Precision Medicine for more Oxygen) public–private partnership sponsored by Health Holland involving many private partners that contribute in cash and/or in kind (Boehringer Ingelheim, Breathomix, Fluidda, Ortec Logiqcare, Philips, Quantib-U, Smartfish, SODAQ, Thirona, TopMD and Novartis), and she has served in advisory boards for AstraZeneca, GSK and Boehringer Ingelheim with money paid to her institution. Conflict of interest: C. Porsbjerg has nothing to disclose., (Copyright ©The authors 2021.)

Molecular profiling of exhaled breath by electronic nose (eNose) might be suitable as a noninvasive tool that can help in monitoring of clinically unstable COPD patients. However, supporting data are still lacking. Therefore, as a first step, this study aimed to determine the accuracy of exhaled breath analysis by eNose to identify COPD patients who recently exacerbated, defined as an exacerbation in the previous 3 months. Data for this exploratory, cross-sectional study were extracted from the multicentre BreathCloud cohort. Patients with a physician-reported diagnosis of COPD (n=364) on maintenance treatment were included in the analysis. Exacerbations were defined as a worsening of respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both. Data analysis involved eNose signal processing, ambient air correction and statistics based on principal component (PC) analysis followed by linear discriminant analysis (LDA). Before analysis, patients were randomly divided into a training (n=254) and validation (n=110) set. In the training set, LDA based on PCs 1-4 discriminated between patients with a recent exacerbation or no exacerbation with high accuracy (receiver operating characteristic (ROC)-area under the curve (AUC)=0.98, 95% CI 0.97-1.00). This high accuracy was confirmed in the validation set (AUC=0.98, 95% CI 0.94-1.00). Smoking, health status score, use of inhaled corticosteroids or vital capacity did not influence these results. Exhaled breath analysis by eNose can discriminate with high accuracy between COPD patients who experienced an exacerbation within 3 months prior to measurement and those who did not. This suggests that COPD patients who recently exacerbated have their own exhaled molecular fingerprint that could be valuable for monitoring purposes., Competing Interests: Conflict of interest: J.J.M.H. van Bragt reports an unrestricted research grant from Boehringer Ingelheim during the conduct of the study. Conflict of interest: P. Brinkman has nothing to disclose. Conflict of interest: R. de Vries is COO of and has a considerable interest in the start-up company Breathomix BV. Conflict of interest: S.J.H. Vijverberg has nothing to disclose. Conflict of interest: E.J.M. Weersink has nothing to disclose. Conflict of interest: E.G. Haarman has nothing to disclose. Conflict of interest: F.H.C. de Jongh has nothing to disclose. Conflict of interest: S. Kester has nothing to disclose. Conflict of interest: A. Lucas has nothing to disclose. Conflict of interest: J.C.C.M. in 't Veen reports faculty grants from Boehringer Ingelheim, Teva and Chiesi, and personal fees for an international advisory board from Sanofi, outside the submitted work. Conflict of interest: P.J. Sterk reports being scientific advisor to and having a formally inconsiderable interest in the start-up company Breathomix BV. Conflict of interest: E.H.D. Bel reports grants and personal fees from AstraZeneca, GSK, Novartis, and Teva, and personal fees from Sanofi/Regeneron, Boehringer Ingelheim, Vectura, and Sterna, outside the submitted work. Conflict of interest: A.H. Maitland-van der Zee reports personal fees for advisory boards from AstraZeneca and Boehringer Ingelheim, and unrestricted research grants from Boehringer Ingelheim and GSK, during the conduct of the study., (Copyright ©ERS 2020.)

Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m -2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day -1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day -1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries., Competing Interests: Conflict of interest: J.J.M.H. van Bragt has nothing to disclose. Conflict of interest: I.M. Adcock has nothing to disclose. Conflict of interest: E.H.D. Bel reports grants and personal fees from AstraZeneca, GSK and Novartis, grants from Teva, and personal fees from Boehringer Ingelheim, Sanofi/Regeneron, Vectura and Sterna, outside the submitted work. Conflict of interest: G-J. Braunstahl reports grants from GSK, Novartis, AstraZeneca and Chiesi, outside the submitted work. Conflict of interest: A. Ten Brinke reports institutional fees for research advisory boards and lectures from GSK, Teva and AstraZeneca, institutional fees for research advisory boards from Sanofi, Novartis and Boehringer Ingelheim, outside the submitted work. Conflict of interest: J. Busby has nothing to disclose. Conflict of interest: G.W. Canonica reports personal fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, GSK, MSD, Novartis, Roche, Sanofi-Aventis and Teva, during the conduct of the study. Conflict of interest: H. Cao is an employee of Novartis, which is one of the funding pharmaceutical companies of SHARP. Conflict of interest: K.F. Chung has received honoraria for participating in advisory board meetings from GSK, AstraZeneca, Novartis, Merck, Boehringer Ingelheim and Teva regarding treatments for asthma and chronic obstructive pulmonary disease and has also been remunerated for speaking engagements. Conflict of interest: Z. Csoma has nothing to disclose. Conflict of interest: B. Dahlén reports advisory board membership for Teva, GSK and Sanofi, personal fees for lectures from AstraZeneca, outside the submitted work. Conflict of interest: E. Davin has nothing to disclose. Conflict of interest: S. Hansen has nothing to disclose. Conflict of interest: E. Heffler reports personal fees from AstraZeneca, Sanofi Genzyme, Teva, Novartis, GSK, Circassia and Nestle Purina, outside the submitted work. Conflict of interest: I. Horvath reports personal fees from AstraZeneca, Boehringer Ingelheim, GSK, Chiesi, Berlin-Chemie, Roche, MSD, CSL and Sager Pharma, outside the submitted work. Conflict of interest: S. Korn reports personal fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Teva and Roche, grants and personal fees from GSK and Novartis, during the conduct of the study. Conflict of interest: M. Kots is a full time Chiesi Famaceutici SpA employee, Global clinical development department. Conflict of interest: P. Kuna reports personal fees for lectures and advisory board work from AstraZeneca and Novartis, personal fees for lectures and nonfinancial support for meeting attendance from Berlin-Chemie, Menarini and Boehringer Ingelheim, outside the submitted work. Conflict of interest: N. Kwon is an employee of GSK. Conflict of interest: R. Louis reports grants and personal fees for advisory board work from GSK, AstraZeneca and Novartis, grants from Chiesi, outside the submitted work. Conflict of interest: V. Plaza reports grants, personal fees and nonfinancial support from Chiesi, grants and personal fees from AstraZeneca, personal fees from ALK, Mundipharma and Sanofi, grants from Menarini, outside the submitted work. Conflict of interest: C. Porsbjerg has nothing to disclose. Conflict of interest: D. Ramos-Barbon has nothing to disclose. Conflict of interest: L.B. Richards has nothing to disclose. Conflict of interest: S. Škrgat reports personal fees for lectures and scientific discussion at symposia from Teva and Boehringer, personal fees for lectures and advisory boards from AstraZeneca, Glaxo, Berlin-Chemie and Chiesi, outside the submitted work. Conflict of interest: J.K. Sont has nothing to disclose. Conflict of interest: S.J.H. Vijverberg has nothing to disclose. Conflict of interest: E.J. Weersink has nothing to disclose. Conflict of interest: V. Yasinska has nothing to disclose. Conflict of interest: S.S. Wagers reports consultancy fees from the European Respiratory Society, during the conduct of the study; consultancy fees from King's College Hospital NHS Foundation Trust, Academic Medical Research, AMC Medical Research BV, Asthma UK, Athens Medical School, Boehringer Ingelheim International GmbH, CHU de Toulouse, CIRO, DS Biologicals Ltd, École Polytechnique Fédérale de Lausanne, European Respiratory Society, FISEVI, Fluidic Analytics Ltd, Fraunhofer IGB, Fraunhofer ITEM, GSK R&D Ltd, Holland and Knight, Karolinska Institutet Fakturor, KU Leuven, Longfonds, National Heart and Lung Institute, Novartis Pharma AG, Owlstone Medical Ltd, PExA AB, UCB Biopharma SPRL, UCB Biosciences GmbH, Umeå University, University Hospital Southampton NHS Foundation Trust, Università Campus Bio-Medico di Roma, Universita Cattolica Del Sacro Cuore, Universität Ulm, University of Bern, University of Edinburgh, University of Hull, University of Leicester, University of Loughborough, University of Luxembourg, University of Manchester, University of Nottingham, Vlaams Brabant, Dienst Europa, Imperial College London, Boehringer Ingelheim, Breathomix, Gossamer Bio, AstraZeneca and CIBER, outside the submitted work. Conflict of interest: R. Djukanovic reports receiving fees for lectures at symposia organised by Novartis, AstraZeneca and Teva, consultation for Teva and Novartis as member of advisory boards, and participation in a scientific discussion about asthma organised by GSK; and is a co-founder and current consultant, and has shares in Synairgen, a University of Southampton spin out company. Conflict of interest: A.H. Maitland-van der Zee reports personal fees for participating in an advisory board from AstraZeneca and Boehringer Ingelheim, unrestricted research grants from Boehringer Ingelheim and GSK., (Copyright ©ERS 2020.)