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      Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes

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          Abstract

          The Global Initiative for Asthma (GINA) Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances (e.g., medication availability). This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes.

          GINA recommends that asthma in adults and adolescents should not be treated solely with short-acting β 2-agonist (SABA), because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids (ICS). Large trials show that as-needed combination ICS–formoterol reduces severe exacerbations by ⩾60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function, and inflammatory outcomes as daily ICS plus as-needed SABA.

          Key changes in GINA 2021 include division of the treatment figure for adults and adolescents into two tracks. Track 1 (preferred) has low-dose ICS–formoterol as the reliever at all steps: as needed only in Steps 1–2 (mild asthma), and with daily maintenance ICS–formoterol (maintenance-and-reliever therapy, “MART”) in Steps 3–5. Track 2 (alternative) has as-needed SABA across all steps, plus regular ICS (Step 2) or ICS–long-acting β 2-agonist (Steps 3–5). For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting muscarinic antagonists and azithromycin, with add-on biologic therapies for severe asthma. For children 6–11 years, new treatment options are added at Steps 3–4.

          Across all age groups and levels of severity, regular personalized assessment, treatment of modifiable risk factors, self-management education, skills training, appropriate medication adjustment, and review remain essential to optimize asthma outcomes.

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          International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma.

          Severe or therapy-resistant asthma is increasingly recognised as a major unmet need. A Task Force, supported by the European Respiratory Society and American Thoracic Society, reviewed the definition and provided recommendations and guidelines on the evaluation and treatment of severe asthma in children and adults. A literature review was performed, followed by discussion by an expert committee according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach for development of specific clinical recommendations. When the diagnosis of asthma is confirmed and comorbidities addressed, severe asthma is defined as asthma that requires treatment with high dose inhaled corticosteroids plus a second controller and/or systemic corticosteroids to prevent it from becoming "uncontrolled" or that remains "uncontrolled" despite this therapy. Severe asthma is a heterogeneous condition consisting of phenotypes such as eosinophilic asthma. Specific recommendations on the use of sputum eosinophil count and exhaled nitric oxide to guide therapy, as well as treatment with anti-IgE antibody, methotrexate, macrolide antibiotics, antifungal agents and bronchial thermoplasty are provided. Coordinated research efforts for improved phenotyping will provide safe and effective biomarker-driven approaches to severe asthma therapy.
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            Interpretative strategies for lung function tests.

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              An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice.

              The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.
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                Author and article information

                Journal
                Am J Respir Crit Care Med
                Am J Respir Crit Care Med
                ajrccm
                American Journal of Respiratory and Critical Care Medicine
                American Thoracic Society
                1073-449X
                1535-4970
                18 October 2021
                01 January 2022
                18 October 2021
                : 205
                : 1
                : 17-35
                Affiliations
                [ 1 ]The Woolcock Institute of Medical Research and The University of Sydney, Sydney, Australia;
                [ 2 ]Monroe Carell Jr. Children’s Hospital at Vanderbilt, Vanderbilt University Medical Center, Nashville, Tennessee;
                [ 3 ]Department of Medicine, University of Cape Town, Cape Town, South Africa;
                [ 4 ]Leicester National Institute for Health Research Biomedical Research Centre, University of Leicester, Leicester, United Kingdom;
                [ 5 ]Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium;
                [ 6 ]Departments of Epidemiology and Respiratory Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands;
                [ 7 ]Pulmonary Department, Mainz University Hospital, Mainz, Germany;
                [ 8 ]Federal University of Bahia, Salvador, Bahia, Brazil;
                [ 9 ]Department of Pediatrics, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands;
                [ 10 ]Divisions of Medical Communication and Pulmonary Medicine, Department of Medicine, Brigham and Woman’s Hospital, Boston, Massachusetts;
                [ 11 ]Harvard Medical School, Boston, Massachusetts;
                [ 12 ]University of British Columbia, Vancouver, British Columbia, Canada;
                [ 13 ]Imperial College London, London, United Kingdom;
                [ 14 ]Kagoshima University, Kagoshima, Japan;
                [ 15 ]The Chinese University of Hong Kong, Hong Kong;
                [ 16 ]Breathe Chicago Center, University of Illinois Chicago, Chicago, Illinois;
                [ 17 ]Locum General Practitioner, London, United Kingdom;
                [ 18 ]China–Japan Friendship Hospital, Peking University, Beijing, China;
                [ 19 ]Department of Respiratory Medicine, Liverpool University Hospitals National Health Service Foundation Trust, United Kingdom;
                [ 20 ]Department of Medicine, University of Cambridge, Cambridge, United Kingdom;
                [ 21 ]Pediatric Respiratory Division, Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil;
                [ 22 ]Usher Institute, University of Edinburgh, Edinburgh, United Kingdom;
                [ 23 ]Department of Pulmonology, Celal Bayar University, Manisa, Turkey; and
                [ 24 ]Institut universitaire de cardiologie et de pneumologie de Québec and
                [ 25 ]Département de médecine, Université Laval, Québec, Québec, Canada
                Author notes
                Correspondence and requests for reprints should be addressed to Helen K. Reddel, M.B. B.S., Ph.D., Woolcock Institute of Medical Research, 431 Glebe Point Road, Glebe, NSW 2037, Australia. E-mail: helen.reddel@ 123456sydney.edu.au .
                Author information
                https://orcid.org/0000-0002-6695-6350
                https://orcid.org/0000-0003-0432-2704
                https://orcid.org/0000-0002-5064-5849
                https://orcid.org/0000-0002-9345-4903
                https://orcid.org/0000-0001-7021-8505
                https://orcid.org/0000-0001-6731-9452
                https://orcid.org/0000-0003-2715-9890
                https://orcid.org/0000-0002-5367-5226
                https://orcid.org/0000-0002-7268-7433
                https://orcid.org/0000-0001-8080-3812
                https://orcid.org/0000-0001-8454-0087
                https://orcid.org/0000-0001-5525-4778
                https://orcid.org/0000-0002-1807-3246
                https://orcid.org/0000-0002-0228-572X
                https://orcid.org/0000-0002-8118-8871
                https://orcid.org/0000-0001-7319-1133
                https://orcid.org/0000-0001-7022-3056
                https://orcid.org/0000-0002-4032-0944
                https://orcid.org/0000-0003-3485-9393
                Article
                202109-2205PP
                10.1164/rccm.202109-2205PP
                8865583
                34658302
                760c6a96-c24d-4b80-92fc-72ca9abb13c3
                Copyright © 2022 by the American Thoracic Society

                This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0. For commercial usage and reprints, please e-mail Diane Gern ( dgern@ 123456thoracic.org ).

                History
                : 27 September 2021
                : 18 October 2021
                Page count
                Figures: 6, Tables: 1, References: 96, Pages: 19
                Funding
                Funded by: Global Initiative for Asthma (GINA)
                Categories
                Pulmonary Perspective

                asthma,asthma diagnosis,asthma management,asthma prevention

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