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A proactive heating method is presented aiming at reducing the energy consumption in a HVAC system while maintaining the thermal comfort of the occupants. The proposed technique fuses time predictions for the zones’ temperatures, based on a deterministic subspace identification method, and zones’ occupancy predictions, based on a mobility model, in a decision scheme that is capable of regulating the balance between the total energy consumed and the total discomfort cost. Simulation results for various occupation-mobility models demonstrate the efficiency of the proposed technique.

Background: Vaccination is vital for achieving population immunity to severe acute respiratory syndrome coronavirus 2, but vaccination hesitancy presents a threat to achieving widespread immunity. Vaccine acceptance in chronic potentially immunosuppressed patients is largely unclear, especially in patients with asthma. The aim of this study was to investigate the vaccination experience in people with severe asthma., Methods: Questionnaires about vaccination beliefs (including the Vaccination Attitudes Examination (VAX) scale, a measure of vaccination hesitancy-related beliefs), vaccination side-effects, asthma control and overall safety perceptions following coronavirus disease 2019 (COVID-19) vaccination were sent to patients with severe asthma in 12 European countries between May and June 2021., Results: 660 participants returned completed questionnaires (87.4% response rate). Of these, 88% stated that they had been, or intended to be, vaccinated, 9.5% were undecided/hesitant and 3% had refused vaccination. Patients who hesitated or refused vaccination had more negative beliefs towards vaccination. Most patients reported mild (48.2%) or no side-effects (43.8%). Patients reporting severe side-effects (5.7%) had more negative beliefs. Most patients (88.8%) reported no change in asthma symptoms after vaccination, while 2.4% reported an improvement, 5.3% a slight deterioration and 1.2% a considerable deterioration. Almost all vaccinated (98%) patients would recommend vaccination to other severe asthma patients., Conclusions: Uptake of vaccination in patients with severe asthma in Europe was high, with a small minority refusing vaccination. Beliefs predicted vaccination behaviour and side-effects. Vaccination had little impact on asthma control. Our findings in people with severe asthma support the broad message that COVID-19 vaccination is safe and well tolerated., Competing Interests: Conflict of interest: A. Bossios reports support from Novartis for attending meetings, outside the submitted work; participation on a data safety monitoring or advisory board for AstraZeneca, GSK, Novartis, Teva and Sanofi, outside the submitted work; and is a member of the Steering Committee of SHARP, Secretary of Assembly 5 (Airway Diseases, Asthma, COPD and Chronic Cough) of the European Respiratory Society and Vice-chair of the Nordic Severe Asthma Network, outside the submitted work. K. Katsoulis reports payment or honoraria for lectures presentations, speakers bureaus, manuscript writing or educational events from GSK, Novartis and AstraZeneca; and support received from Menarini and Novartis for attending meetings and/or travel, outside the submitted work. K. Kostikas reports grants or contracts from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir, outside the submitted work; consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis and Sanofi-Genzyme, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini, Novartis, Sanofi-Genzyme and WebMD, outside the submitted work; and is a member of the GOLD Assembly, disclosures made outside the submitted work. N. Rovina reports receiving honoraria for lectures and presentations from Chiesi, AstraZeneca, Menarini, Gilead and Baxter, outside the submitted work. K. Bieksienė reports receiving lecture honoraria from Berlin-Chemie, AstraZeneca and Norameda, outside the submitted work. A. ten Brinke reports grants from Teva and GSK, outside the submitted work; consulting fees from AstraZeneca, GSK, Novartis, Sanofi-Genzyme and Teva, outside the submitted work; and payment or honoraria for lectures received from AstraZeneca, GSK, Sanofi-Genzyme and Teva, outside the submitted work; and is Chair of the Dutch severe asthma registry RAPSODI, outside the submitted work, and ERS SHARP CRC national lead for the Netherlands. R. Chaudhuri reports grants or contracts from AstraZeneca, outside the submitted work; payment of honoraria for lectures from GSK, AstraZeneca, Teva, Chiesi, Sanofi and Novartis, outside the submitted work; support for attending meetings and/or travel from Chiesi, Sanofi and GSK, outside the submitted work; and participation in advisory board meetings for GSK, AstraZeneca, Teva, Chiesi and Novartis, outside the submitted work. H. Rupani reports grant funding from GSK and AstraZeneca, outside the submitted work; payments for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, GSK, Novartis and Teva, outside the submitted work; and is an associate editor of this journal. P. Howarth is an employee of GSK, disclosure made outside the submitted work. C. Porsbjerg reports grants or contracts from AstraZeneca, GSK, Novartis, Teva, Sanofi, Chiesi and ALK, outside the submitted work; consulting fees from AstraZeneca, GSK, Novartis, Teva, Sanofi, Chiesi and ALK, outside the submitted work; personal honoraria from AstraZeneca, GSK, Novartis, Teva, Sanofi, Chiesi and ALK, outside the submitted work; participation on a data safety monitoring or advisory board for AstraZeneca, GSK, Novartis, Teva, Sanofi, Chiesi and ALK, outside the submitted work. E.H. Bel reports research grants from GSK and Teva, outside the submitted work; and consulting fees from AstraZeneca, GSK, Sterna Biologicals, Chiesi Pharmaceuticals, Sanofi/Regeneron and Teva, outside the submitted work. M.E. Hyland reports grants or contracts from Teva outside the submitted work; and payment received from GSK for writing educational material for respiratory nurses, outside the submitted work. The remaining authors have nothing to disclose., (Copyright ©The authors 2023.)

Introduction: We evaluated the tobacco odor intensity of cigarettes based on a large consumer panel and explored the differences of odor intensity perception based on sex, age and smoking habits., Methods: The perceived intensity of tobacco odor of cigarettes was evaluated using a consumer group method. A consumer panel of 240 volunteers (80 smokers, 80 ex-smokers and 80 non-smokers) was asked to smell eleven unlit cigarettes and then report their tobacco odor intensity in a specific questionnaire., Results: All volunteers clearly determined the presence of tobacco odor in all cigarettes. There is a general decrease of the perceived odor intensity with age, for both males and females. Moreover, tobacco odor perceived intensity, among all volunteer groups (smokers, non-smokers, ex-smokers), was higher for females than for males. Non-smokers declared the highest perceived tobacco odor intensities, followed by ex-smokers and smokers, who recorded the lowest perceived odor intensity. Perceived odor intensity decreased with age, with a higher rate for females compared to males, but independently of the smoking habits., Conclusions: Regular and untrained consumers confirmed that a tobacco odor of different intensity can be perceived during the smelling of unlit cigarettes. This perceived intensity depends on sex, age and smoking habits., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported., (© 2023 Zervas E. et al.)

Background: An objective of the Severe Heterogeneous Asthma Registry, Patient-centered (SHARP) is to produce real-world evidence on a pan-European scale by linking nonstandardised, patient-level registry data. Mepolizumab has shown clinical efficacy in randomised controlled trials and prospective real-world studies and could therefore serve as a proof of principle for this novel approach. The aim of the present study was to harmonise data from 10 national severe asthma registries and characterise patients receiving mepolizumab, assess its effectiveness on annual exacerbations and maintenance oral glucocorticoid (OCS) use, and evaluate treatment patterns., Methods: In this observational cohort study, registry data (5871 patients) were extracted for harmonisation. Where harmonisation was possible, patients who initiated mepolizumab between 1 January 2016 and 31 December 2021 were examined. Changes of a 12-month (range 11-18 months) period in frequent (two or more) exacerbations, maintenance OCS use and dose were analysed in a privacy-preserving manner using meta-analysis of generalised estimating equation parameters. Periods before and during the coronavirus disease 2019 pandemic were analysed separately., Results: In 912 patients who fulfilled selection criteria, mepolizumab significantly reduced frequent exacerbations (OR 0.18, 95% CI 0.13-0.25), maintenance OCS use (OR 0.75, 95% CI 0.61-0.92) and dose (mean -3.93 mg·day -1 , 95% CI -5.24-2.62 mg·day -1 ) in the pre-pandemic group, with similar trends in the pandemic group. Marked heterogeneity was observed between registries in patient characteristics and mepolizumab treatment patterns., Conclusions: By harmonising patient-level registry data and applying federated analysis, SHARP demonstrated the real-world effectiveness of mepolizumab on asthma exacerbations and maintenance OCS use in severe asthma patients across Europe, consistent with previous evidence. This paves the way for future pan-European real-world severe asthma studies using patient-level data in a privacy-proof manner., Competing Interests: Conflict of interest: Z. Csoma reports lecture honoraria from AstraZenca, Sanofi, Teva and GSK outside the submitted work. A. ten Brinke reports grants and payment for expert testimony from GlaxoSmithKline, AstraZeneca, TEVA and Sanofi-Genzyme Regeneron outside the submitted work. B. Gemicioglu reports support for the present work from GSK; lecture honoraria from GSK, Novartis, Deva, Chiesi, Abdi İbrahim and Sandoz; travel support from GSK, AstraZeneca and Novartis; and leadership positions with SHARP (Turkey Coordinator), GARD (Turkey Coordinator) and Turkish Board of Pulmonology (Chair), outside the submitted work. C.C. Loureiro reports grants from GSK; consulting fees from AstraZeneca, GSK, Novartis and Sanofi; lecture honoraria from AstraZeneca, GSK, Novartis, Sanofi and Teva; and travel support from AstraZeneca, Novartis and Sanofi, outside the submitted work. D. Ramos-Barbón reports honoraria and institutional research funding from GSK, outside the submitted work. E.H. Bel reports grants from GlaxoSmithKline and TEVA; lecture honoraria from GlaxoSmithKline, TEVA, AstraZeneca, Sanofi-Genzyme, Regeneron, Chiesi and Sterna, outside the submitted work. J.A. Kroes reports grants from AstraZeneca, outside the submitted work. K. Samitas reports lecture honoraria from MSD, GSK, Chiesi, Novartis, AstraZeneca, ELPEN, Menarini, BMS, Specialty Therapeutics, Boehringer and Rontis; travel support from Boehringer; advisory board participation with AstraZeneca, GSK and Specialty Therapeutics; and a leadership position with the Hellenic Thoracic Society, outside the submitted work. L. Pérez de Llano reports support for the present work from AstraZeneca; grants from AstraZeneca, Faes, TEVA and Sanofi; lecture honoraria from AstraZeneca, TEVA, Sanofi, MSD, Leo Pharma, Gebro, GSK, Novartis, Chiesi, Techdow Pharma and Gilead; patents from AstraZeneca, Novartis, Faes, TEVA, GSK, Sanofi and Chiesi; and advisory board participation with AstraZeneca, outside the submitted work. R.W. Jakes reports support for the present work from GSK, as an employee and shareholder. S. Škrgat reports honoraria for lectures and educational events, supported by AstraZeneca, Sanofi, Chiesi, Pliva Teva and Medis; and participation on advisory boards of AstraZeneca, Chiesi and Sanofi, outside the submitted work. A. Bourdin reports support for the present work from GSK; grants from AstraZeneca, GSK and Boehringer Ingelheim; lecture honoraria, nonfinancial support and other support from AstraZeneca, GSK, Boehringer Ingelheim, Novartis, TEVA, Chiesi Farmaceuticals, Actelion, Gilead, Roche and Regeneron, outside the submitted work. B. Dahlén reports grants from Novartis and GSK; and consulting fees from AstraZeneca, Teva and Sanofi, outside the submitted work. E. Zervas reports advisory board fees from Astra, Chiesi, Elpen, GSK, Menarini, MSD and Novartis; honoraria and fees for lectures from Astra, Boehringer, Bristol-Myers, Chiesi, Elpen, GSK, Menarini, MSD and Novartis; travel accommodations and meeting expenses from Astra, Boehringer, Chiezi, Galenica, GSK, Elpen, MSD, Novartis and Roche; and holds a leadership role as Secretary General of Hellenic Thoracic Society, outside the submitted work. E. Heffler reports consulting fees and lecture honoraria from AstraZeneca, Sanofi, Regeneron, Novartis, GSK, Stallergenes-Greer and Circassia outside the submitted work. F. Schleich reports grants from GSK and AstraZeneca; and consulting fees and lecture honoraria from GSK, AstraZeneca and Chiesi, outside the submitted work. K. Eger reports that TEVA sponsored printing their PhD thesis, outside the submitted work. K. Bieksiene reports lecture honoraria from AstraZeneca and Berlin Chemie, outside the submitted work. M. Paula Rezelj reports lecture honoraria from AstraZeneca, Novartis, GSK and Stallergenes, outside the submitted work. M. Masoli reports an investigator-led nonpromotional grant from GlakoSmithKline and an advisory board fee from AstraZeneca outside the submitted work. N. Kwon reports support for the present work from GSK, as an employee and shareholder. P. Howarth reports support for the present work from GSK, as an employee and shareholder. P. Kopač reports lecture honoraria and advisory board participation from AstraZeneca, GSK and Berlin-Chemie outside the submitted work. R. Alfonso-Cristancho reports support for the present work from GSK, as an employee and shareholder. G. Celik reports consulting fees and lecture honoraria from Novartis and GSK outside the submitted work. J.K. Sont reports grants from AstraZeneca; outside the submitted work. All other authors have nothing to disclose., (Copyright ©The authors 2023.)

Despite that COPD remains one of the most common respiratory diseases worldwide, it can be managed effectively with certain treatments and, more importantly, be prevented by the early implementation of various measures. The pathology and pathophysiology of this disease continue to be studied, with new pharmacological and invasive therapies emerging. In this consensus paper, the Working Group of the Hellenic Thoracic Society aimed to consolidate the up-to-date information and new advances in the treatment of COPD. Local and international data on its prevalence are presented, with revised strategies on the diagnostic approach and the evaluation of risk assessment and disease severity classification. Emphasis is placed on the management and therapy of patients with COPD, covering both common principles, specialized modalities, and algorithms to distinguish between home care and the need for hospitalization. Although pharmacological treatment is commonly recognized in COPD, an integrative approach of pulmonary rehabilitation, physical activity, patient education, and self-assessment should be encountered for a comprehensive treatment, prevention of exacerbations, and increased quality of life in patients.

Introduction: Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown., Materials and Methods: The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies., Results: Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity., Conclusion: Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation., Competing Interests: Conflict of interest: L.G. Heaney reports the following relationships outside the submitted work: academic lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma (industrial pharma partners: Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche/Genentech, GlaxoSmithKline and Boehringer Ingelheim); project grant funding from Medimmune, Novartis UK, Roche/Genentech and GlaxoSmithKline; travel funding support to international respiratory meetings received from AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva and GlaxoSmithKline; participated on advisory boards for AstraZeneca, Novartis, GlaxoSmithKline, Chiesi, Teva, Theravance and Vectura. Conflict of interest: B. Dahlén reports the following relationships outside the submitted work: grant received from GSK and Novartis to support Karolinska Severe Asthma Centre; personal consulting fees received from GSK, Novartis, Teva and AstraZeneca; consulting fees, paid to the institution, received from Region Stockholm; personal honoraria received from GSK, Novartis, Teva and AstraZeneca. Conflict of interest: S. Popović-Grle reports the following relationships outside the submitted work: payment for educational events from Abbot, Alkaloid, AstraZeneca, BerlinChemie Menarini, Boehringer Ingelheim, Medis, Novartis, Pliva-Teva, PharmaS, Providens, Salvus, Sandoz, Sanofi-Aventis and SwixxPharma; participation on advisory boards for AstraZeneca, Boehringer Ingelheim, BerlinChemie Menarini, GSK, Novartis, Pliva-Teva, PharmaS, Sanofi-Aventis and SwixxPharma. Conflict of interest: V. Sedlák reports the following relationships outside the submitted work: payment for presentations received from AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi; payment for expert testimony payments received from AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi; payment for participation on a data safety monitoring board or advisory board received from AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi. Conflict of interest: L. Lehtimäki reports the following relationships outside the submitted work: fees for lectures or advisory board meetings received from ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, GSK, Mundipharma, Novartis, Orion Pharma and Sanofi; owner of shares for Ausculthing OY. Conflict of interest: A. Bourdin reports the following relationships outside the submitted work: unrestricted grants received from AstraZeneca and Boehringer Ingelheim; consulting fees received from Astra Zeneca, GSK, Novartis, Sanofi Regeneron, Boehringer Ingelheim and Chiesi; payment or honoraria received for lectures, presentations, speakers bureaus, manuscript writing or educational events received from AstraZeneca, GSK, Novartis, Sanofi Regeneron, Boehringer Ingelheim and Chiesi; support for attending meetings and/or travel received from Astra Zeneca, GSK, Novartis, Sanofi Regeneron, Boehringer Ingelheim and Chiesi. Conflict of interest: S. Korn reports the following relationships outside the submitted work: consulting fees received from AstraZeneca, Novartis, GlaxoSmithKline and Sanofi; payment or honoraria received for lectures and presentations from AstraZeneca, Novartis, GlaxoSmithKline and Sanofi; participation on a data safety monitoring board or advisory board for AstraZeneca, Novartis and GlaxoSmithKline. Conflict of interest: M.W. Butler reports the following relationships outside the submitted work: payment or honoraria received for lectures and presentations from AstraZeneca, Novartis and GlaxoSmithKline; support received for international meeting attendance received from AstraZeneca; participation on Advisory Boards for ALK Abello, AstraZeneca, GlaxoSmithKline and Novartis; Chair of Medical Advisory Group, board member of Asthma Society of Ireland, Ireland member of GINA Assembly, President of Irish Thoracic Society (2022 to present). Conflict of interest: G.W. Canonica reports the following relationships outside the submitted work: payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from AstraZeneca, GSK, Novartis and Sanofi; participation on a data safety monitoring board or advisory board for AstraZeneca, GSK, Novartis and Sanofi; leadership or fiduciary role in other board, society, committee or advocacy group for EAACI Methodology Committee, REG Vice President and SANI Steering Committee. Conflict of interest: K. Beiksiene reports the following relationships outside the submitted work: payment or honoraria received for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from AstraZeneca and Berlin Chemie. Conflict of interest: A. ten Brinke reports the following relationships outside the submitted work: unrestricted grants received from TEVA, GSK and AstraZeneca; consulting fees paid to the institution from GSK, Sanofi, TEVA, AstraZeneca and Boehringer Ingelheim; payments for lectures, paid to the institution, received from GSK, TEVA, AstraZeneca and Sanofi; participation on research advisory boards for GSK, Sanofi, AstraZeneca, Boehringer Ingelheim and TEVA; Chair of Dutch severe asthma registry RAPSODI. Conflict of interest: P. Kuna reports the following relationships outside the submitted work: personal fees received for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from Adamed, AstraZeneca, Boehringer Ingelheim, Berlin Chemie Menarini, Alvogen, Glenmark, Novartis, GSK, Chiesi, Polpharma and Teva. Conflict of interest: C. Chaves Loureiro reports the following relationships outside the submitted work: Consulting fees received from AstraZeneca and GSK. Payment for r presentations and speakers bureaus received from AstraZeneca, GSK, Novartis and Sanofi-Aventis. Support for attending meetings received from AstraZeneca, Novartis, Nippon, Sanofi-Aventis, Tecnifarma and VitalAire. Participation on Advisory Boards for AstraZeneca, GSK, Novartis and Sanofi-Aventis. Conflict of interest: Z. Lazic reports the following relationships outside the submitted work: payment or honoraria for educational events received from AstraZeneca, BerlinChemie Menarini, Boehringer Ingelheim, Novartis, PharmaS, Providens, Sandoz and Actavis-Teva Serbia; participation on Advisory Boards for AstraZeneca, Boehringer Ingelheim, BerlinChemie Menarini, Novartis and Actavis-Teva Serbia. Conflict of interest: S. Škrgat reports the following relationships outside the submitted work: honoraria received for lectures and educational events from Astra Zeneca, Pliva Teva, Berlin Chemie, Chiesi and Medis; participation on local advisory boards organized by AstraZeneca. Conflict of interest: J. Leuppi reports the following relationships outside the submitted work: J. Leuppi is supported by grants from the Swiss National Science Foundation (SNF 160072 and 185592) and by Swiss Personalised Health Network (SPHN 2018DR108); J. Leuppi has also received unrestricted grants from AstraZeneca AG Switzerland, Boehringer Ingelheim GmbH Switzerland, GSK AG Switzerland, and Novartis AG Switzerland. Conflict of interest: B. Gemicioglu reports the following relationships outside the submitted work: grants or contracts received from AstraZeneca, Novartis, GlaxoSmithKline and Sanofi; payment or honoraria received for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from Novartis; support for attending meetings received from Novartis; participation on a data safety monitoring board or advisory board for GlaxoSmithKline. Conflict of interest: A. Bossios reports the following relationships outside the submitted work: payment or honoraria received for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from Astra Zeneca, GSK and TEVA; support for attending meetings and/or travel received from Novartis; participation on a data safety monitoring board or advisory board for AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi; member of the steering committee of SHARP, Secretary of Assembly 5 (Airway diseases, asthma, COPD and chronic cough), European Respiratory Society; vice-chair of Nordic Severe Asthma Network (NSAN). Conflict of interest: C.M. Porsbjerg reports the following relationships outside the submitted work: grants or contracts, paid to the institution, received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK; consulting fees received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK; participation on a data safety monitoring board or advisory board for AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK. Conflict of interest: E.H. Bel reports the following relationships outside the submitted work: research grants received from GSK and Teva; consulting fees received from Teva, Sanofi, AstraZeneca, GSK, Sterna and Chiesi; participation on a data safety monitoring board or advisory board for AstraZeneca. Conflict of interest: R. Djukanovic reports the following relationships outside the submitted work: funding received for the SHARP CRC from ERS, TEVA, GSK, Novartis, Sanofi and Chiesi; consultancy fees paid to the author received from Synairgen plc, Sanofi-Genzyme Corporation and Galapagos; honorarium for lectures paid to the author received from GlaxoSmithKline, Congress of Interasma, AstraZeneca and Airways Vista, Seoul; personal shares owned for Synairgen. Conflict of interest: L. Renaud reports receiving support for the present manuscript from SHARP CRC supported by GSK, Novartis, Sanofi, Chiesi and Teva. The following relationships are reported outside the submitted work: grants or contracts received from GSK, AZ and Chiesi; consulting fees received from AZ and Sanofi; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events, received from AZ, GSK and Chiesi; patents planned, issued or pending WO 2017/050527 A1 “Method for the diagnosis of airway disease inflammatory subtype”. Conflict of interest: The remaining authors have nothing to disclose., (Copyright ©The authors 2022.)

Background: At the beginning of the pandemic, there have been considerable concerns regarding coronavirus disease 2019 (COVID-19) severity and outcomes in patients with severe asthma treated with biologics., Objective: To prospectively observe a cohort of severe asthmatics treated with biologics for the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and disease severity during the COVID-19 pandemic., Methods: Physicians from centers treating patients with severe asthma all over Greece provided demographic and medical data regarding their patients treated with biologics. Physicians were also asked to follow up patients during the pandemic and to perform a polymerase chain reaction test in case of a suspected SARS-Cov-2 infection., Results: Among the 591 severe asthmatics (63.5% female) included in the study, 219 (37.1%) were treated with omalizumab, 358 (60.6%) with mepolizumab, and 14 (2.4%) with benralizumab. In total, 26 patients (4.4%) had a confirmed SARS-CoV-2 infection, 9 (34.6%) of whom were admitted to the hospital because of severe COVID-19, and 1 required mechanical ventilation and died 19 days after admission. Of the 26 infected patients, 5 (19.2%) experienced asthma control deterioration, characterized as exacerbation that required treatment with systemic corticosteroids. The scheduled administration of the biological therapy was performed timely in all patients with the exception of 2, in whom it was postponed for 1 week according to their doctors' suggestion., Conclusion: Our study confirms that despite the initial concerns, SARS-CoV-2 infection is not more common in asthmatics treated with biologics compared with the general population, whereas the use of biologic treatments for severe asthma during the COVID-19 pandemic does not seem to be related to adverse outcomes from severe COVID-19., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Recently, the Patras Immunotherapy Score (PIOS) has been developed to estimate the survival benefit of patients with advanced non-small-cell lung cancer (aNSCLC) treated with nivolumab or pembrolizumab. The aim of this study was to validate the clinical value of PIOS in an external cohort of aNSCLC patients., Methods: PIOS is a baseline formula produced by the combination of performance status, body mass index, age and line of treatment. In this multicentre study, 626 patients with confirmed NSCLC pathology, who had been treated with nivolumab or pembrolizumab, as well as 444 patients with aNSCLC, who had been managed with chemotherapy alone, were retrospectively enrolled. Predictive and prognostic values of PIOS were finally evaluated., Results: Patients treated with immunotherapy and higher PIOS score had an improved progression-free survival not only in univariate [hazard ratio (HR) = 0.621, p = 0.001], but also in multivariable analysis (HR = 0.651, p = 0.003). In addition, improved overall survival with increasing PIOS score was also observed (HR = 0.608, p < 0.001) with this association remaining statistically significant after adjusting for programmed-cell death ligand 1 (PD-L1) expression (HR = 0.620, p < 0.001). In addition, patients with disease progression (PD) had lower scores compared to those with stable disease (SD), partial response (PR) or complete response (CR) in a two-tier model ( p < 0.001) as well as in a four-tier model (PD, SD, PR and CR; p < 0.001). Prognostic significance of PIOS score also persisted using a binary logistic regression analysis, adjusted for disease stage and PD-L1 status ( p = 0.002, odds ratio: 0.578). Contrarily, PIOS had no prognostic significance in the chemotherapy group; however, upon combined analysis of the two cohorts, PIOS was found to have a significant interaction with the type of treatment (HR = 0.066 with p < 0.001), confirming its predictive value for immunotherapy., Conclusions: This study provides further validation of PIOS in aNSCLC patients treated with anti-PD-1 monotherapy., Competing Interests: Competing interests: The authors declare that there is no conflict of interest., (© The Author(s), 2022.)

The Tobacco Products Directive (TPD) defines enhanced reporting obligations applying to 15 priority additives added to cigarettes and roll-your-own tobacco. A consortium of 12 international tobacco companies submitted 14 reports that were reviewed by an independent scientific body within the Joint Action on Tobacco Control (JATC). The reports were evaluated in accordance with the TPD with regard to their comprehensiveness, methodology and conclusions. Here we present their significant identified methodological limitations. The toxicological and chemical evaluation in the industry reports was mainly based on comparative testing, which lacks discriminative power for products with high toxicity and variability, like cigarettes. The literature reviews were biased, the comparative chemical studies did not assess previously identified pyrolysis products, the toxicological evaluation did not include the assessment of inhalation toxicity, and pyrolysis products were not assessed in terms of toxicity, including their genotoxic and carcinogenic potential. For both chemistry and toxicity testing, the statistical approach applied to test the difference between test and additive-free control cigarettes resulted in a high chance of false negatives. The clinical study for inhalation facilitation and nicotine uptake had limitations concerning study design and statistical analysis, while addictiveness was not assessed. Finally, the methodology used to assess characterizing flavors was flawed. In conclusion, there are significant limitations in the methodology applied by the industry. Therefore, the provided reports are of insufficient quality and are clearly not suitable to decide whether a priority additive should be banned in tobacco products according to the TPD., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported., (© Bolling A. K. et al.)

The European Union Tobacco Products Directive (EU TPD) mandates enhanced reporting obligations for tobacco manufacturers regarding 15 priority additives. Within the Joint Action on Tobacco Control (JATC), a review panel of independent experts was appointed for the scientific evaluation of the additive reports submitted by a consortium of 12 tobacco manufacturers. As required by the TPD, the reports were evaluated based on their comprehensiveness, methodology and conclusions. In addition, we evaluated the chemical, toxicological, addictive, inhalation facilitating and flavoring properties of the priority additives based on the submitted reports, supplemented by the panel's expert knowledge and some independent literature. The industry concluded that none of the additives is associated with concern. Due to significant methodological limitations, we question the scientific validity of these conclusions and conclude that they are not warranted. Our review demonstrates that many issues regarding toxicity, addictiveness and attractiveness of the additives have not been sufficiently addressed, and therefore concerns remain. For example, menthol facilitates inhalation by activation of the cooling receptor TRPM8. The addition of sorbitol and guar gum leads to a significant increase of aldehydes that may contribute to toxicity and addictiveness. Titanium dioxide particles (aerodynamic diameter <10 µm) are legally classified as carcinogenic when inhaled. For diacetyl no report was provided. Overall, the industry reports were not comprehensive, and the information presented provides an insufficient basis for the regulation of most additives. We, therefore, advise MS to consider alternative approaches such as the precautionary principle., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported., (© Havermans A. et al.)

Background: The coronavirus disease 2019 (COVID-19) pandemic has put pressure on healthcare services, forcing the reorganisation of traditional care pathways. We investigated how physicians taking care of severe asthma patients in Europe reorganised care, and how these changes affected patient satisfaction, asthma control and future care., Methods: In this European-wide cross-sectional study, patient surveys were sent to patients with a physician-diagnosis of severe asthma, and physician surveys to severe asthma specialists between November 2020 and May 2021., Results: 1101 patients and 268 physicians from 16 European countries contributed to the study. Common physician-reported changes in severe asthma care included use of video/phone consultations (46%), reduced availability of physicians (43%) and change to home-administered biologics (38%). Change to phone/video consultations was reported in 45% of patients, of whom 79% were satisfied or very satisfied with this change. Of 709 patients on biologics, 24% experienced changes in biologic care, of whom 92% were changed to home-administered biologics and of these 62% were satisfied or very satisfied with this change. Only 2% reported worsening asthma symptoms associated with changes in biologic care. Many physicians expect continued implementation of video/phone consultations (41%) and home administration of biologics (52%)., Conclusions: Change to video/phone consultations and home administration of biologics was common in severe asthma care during the COVID-19 pandemic and was associated with high satisfaction levels in most but not all cases. Many physicians expect these changes to continue in future severe asthma care, though satisfaction levels may change after the pandemic., Competing Interests: Conflict of interest: A. Bourdin reports receiving grants or contracts outside the submitted work from AstraZeneca and Boeringher Ingelheim; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events as well as support for attending meetings and/or travel from AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Chiesi and Amgen, outside the submitted work. Z. Csoma reports receiving honoraria for presentations from Astra/Zeneca, TEVA and Sanofi/Aventis (Hungary) outside the submitted work. E. Heffler reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, Sanofi-Genzyme, Regeneron, Novartis, GSK, Circassia; Stallergenes-Greer and Nestlè Purina outside the submitted work. G.W. Canonica reports receiving consulting fees from AstraZeneca GSK, Novartis, Sanofi and Stallergenes Greer; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, GSK, Novartis, Sanofi, Stallergenes Greer, Menarini, Chiesi and Mylan; participation on data safety monitoring or advisory boards for AstraZeneca, GSK, Novartis, Sanofi, Stallergenes Greer and Chiesi; all disclosures made outside the submitted work. G-J. Braunstahl reports grants or contracts from GSK, AstraZeneca and ALK Abello; consulting fees from GSK, Sanofi, ALK Abello, AstraZeneca and Novartis; payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing or educational events from GSK, Sanofi, ALK Abello, AstraZeneca and Novartis; and is on the scientific board of the Dutch Lung Foundation, task force Asthma NVALT and editorial board NTVAAKI; all disclosures made outside the submitted work. S. van der Sar reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca and GSK; and support received from ALK for attending meetings and/or travel; all disclosures made outside the submitted work. N. Nenasheva reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca plc., Sanofi S.A., Teva Pharmaceuticals, Novartis International AG and Chiesi Farmaceutici S.p.A., outside the submitted work. A. Bossios reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AZ, GSK and Teva; support for attending meetings and/or travel received from Novartis; and participation on a data safety monitoring or advisory boards for AZ, GSK, Novartis, Teva and Sanofi; and is a member of the steering Committee of SHARP, Secretary of Assembly 5 (Airway diseases, asthma, COPD and chronic cough) of the European Respiratory Society and vice-chair of Nordic Severe Asthma Network; all disclosures made outside the submitted work. D. Aronsson reports receiving grants or contracts from ALK-Abello outside the submitted work. A. Egesten reports receiving honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, outside the submitted work. L. Ahlbeck reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca; and participation on data safety monitoring or advisory boards for AstraZeneca, Sanofi and GSK; all disclosures made outside the submitted work. S. Škrgat reports receiving honoraria for lectures and educational events supported by GSK, AstraZeneca, Sanofi, Chiesi, Pliva Teva and Medis; and participation on advisory boards of GSK, AstraZeneca, Chiesi and Sanofi; all disclosures made outside the submitted work. N. Edelbaher reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from GSK, Astra Zeneca, Chiesi, Pliva Teva, Krka, Novartis, Boehringer Ingelheim and Sanofi; and participation on advisory boards of GSK, Astra Zeneca, Chiesi, Novartis and Boehringer Ingelheim; all disclosures made outside the submitted work. J. Rüdiger reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from the Education of Swiss Emergency physicians; and participation on a data safety monitoring board or board for Boehringer Ingelheim; and is a member of the Board of the Swiss Society of Pneumology and President of the Thorax section of the Swiss Ultrasound Society; all disclosures made outside the submitted work. N. Pavlov reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from GSK, Novartis and OM Pharma; support for attending meetings and/or travel received from Boehringer Ingelheim; participation on data safety monitoring or advisory boards for AstraZeneca, GSK, Novartis and Sanofi; all disclosures made outside the submitted work. P. Gianella reports participation on an advisory board for Novartis about Xolair for nasal polyps, outside the submitted work. F. Charbonnier reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Sanofi, Novartis, Mundipharma, AstraZeneca and GSK; participation on data safety monitoring or advisory boards for Sanofi, Novartis, Mundipharma, AstraZeneca and GSK; all disclosures made outside the submitted work. R. Chaudhuri reports receiving grants or contracts from AstraZeneca; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from GSK, AstraZeneca, Teva, Chiesi, Sanofi and Novartis; support for attending meetings and/or travel received from Chiesi, Napp, Sanofi, Boehringer, GSK and AZ; and participation on data safety monitoring or advisory boards for GSK, AstraZeneca, Teva, Chiesi and Novartis; all disclosures made outside the submitted work. S.J. Smith is supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement number 831434 for Taxonomy, Targets, Treatment, and Remission; the JU receives support from the European Union's Horizon 2020 research and innovation programme, and the European Federation of Pharmaceutical Industries and Associates; all disclosures made outside the submitted work. S. Doe reports receiving support for attending meetings and/or travel from GSK and Sanofi, outside the submitted work. L. Heaney reports grants or contracts from Medimmune, Novartis UK, Roche/Genentech Inc., GlaxoSmithKline, Amgen, Genentech/Hoffman la Roche, AstraZeneca, Medimmune, Aerocrine and Vitalograph; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events for Novartis, Hoffman la Roche/Genentech Inc., Sanofi, GlaxoSmithKline, AstraZeneca, Teva and Circassia; support for attending meetings and/or travel from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK and Napp Pharmaceuticals; participation on data safety monitoring or advisory board for Novartis, Hoffman la Roche/Genentech Inc., Sanofi, Evelo Biosciences, GlaxoSmithKline, AstraZeneca, Teva, Theravance and Circassia; all disclosures made outside the submitted work. M. Masoli reports receiving grants or contracts from ERS SHARP to support the study “The burden of severe asthma on HRQoL across Europe”, outside the submitted work. P. Howarth is an employee of GSK. R. Djukanovic reports support for the present manuscript received from ERS, TEVA, GSK, Novartis, Sanofi and Chiesi; consulting fees from Synairgen for which the author is a co-founder and consultant and owns shares, outside the submitted work; and participation on a data safety monitoring or advisory board for Kymab (Cambridge), outside the submitted work. E. Bel reports support for the present manuscript from the ERS; grants or contracts received from GlaxoSmithKline and Teva, outside the submitted work; consulting fees received from AstraZeneca, GlaxoSmithKline, Sanofi, Sterna and Chiesi, outside the submitted work; honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events received from Teva; participation on a data safety monitoring or advisory board for AstraZeneca, outside the submitted work; and leadership or fiduciary roles, unpaid, for SHARP-CRC and RAPSODI (Dutch registry), outside the submitted work. M. Hyland reports receiving grants or contracts from TEVA; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events for GSK; all disclosures made outside the submitted work. The remaining authors have nothing to disclose., (Copyright ©The authors 2022.)