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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.)