E The Global Initiative for Asthma is supported by unrestricted educational grants from: C U D O R P Almirall E R R Boehringer Ingelheim O R Boston Scientific E T L A CIPLA T G O I N N Chiesi A R e O p o D r Clement Clarke t 2 - 0 1 L 4 A GlaxoSmithKline I R E T Merck Sharp & Dohme A M Novartis D E T H GLOBAL STRATEGY FOR Takeda G ASTHMA MANAGEMENT AND PREVENTION I R Y Updated 2015 P O © 2015 Global Initiative for Asthma Visit the GINA website at www.ginaasthma.org C © 2014 Global Initiative for Asthma E C U D O R P E R R O R E T L A T O N O D - L A I R E T A M D E T H G I R Y P O C Global Strategy for Asthma Management and Prevention The GINA reports are available on www.ginasthma.org. E C U Global Strategy for Asthma Management and Prevention (2015 update) D O GINA BOARD OF DIRECTORS* GINA SCIENCE COMMITTEE* GINA PROGRRAM P J. Mark FitzGerald, MD, Chair Helen K. Reddel, MBBS PhD, Chair Suzanne Hurd, PhD University of British Columbia Woolcock Institute of Medical Research Scientific DiErector Vancouver, BC, Canada Sydney, Australia R GRAPHICS ASSISTANCE Eric D. Bateman, MD Eric D. Bateman, MD University of Cape Town Lung Institute University of Cape Town Lung Institute KateR Chisnall Cape Town, South Africa. Cape Town, South Africa. O Louis-Philippe Boulet, MD Allan Becker, MD Université Laval University of Manitoba R Québec, QC, Canada Winnipeg, MB, CANADA E Alvaro A. Cruz, MD Johan C. de Jongste, MD PhD T Federal University of Bahia Erasmus University Medical Center Salvador, BA, Brazil Rotterdam, The Netherlands L A Tari Haahtela, MD Jeffrey M. Drazen, MD (to Dec 2014) Helsinki University Central Hospital Harvard Medical School T Helsinki, Finland Boston, MA, USA O Mark L. Levy, MD J. Mark FitzGerald, MD N The University of Edinburgh University of British Columbia Edinburgh, UK Vancouver, BC, Canada O Paul O'Byrne, MD Hiromasa Inoue, MD McMaster University Kagoshima UnDiversity Hamilton, ON, Canada Kagoshima, Japan - Pierluigi Paggiaro, MD Robert F . Lemanske, Jr., MD L University of Pisa University of Wisconsin Pisa, Italy MadisAon, WI, USA I Soren Erik Pedersen, MD PRaul O'Byrne, MD Kolding Hospital McMaster University Kolding, Denmark EHamilton, ON, Canada T Manuel Soto-Quiroz, MD Soren Erik Pedersen, MD Hospital Nacional de Niños A Kolding Hospital San José, Costa Rica Kolding, Denmark M Helen K. Reddel, MBBS PhD Emilio Pizzichini, MD Woolcock Institute of Medical ReDsearch Universidade Federal de Santa Catarina Sydney, Australia Florianópolis, SC, Brazil E Gary W. Wong, MD T Stanley J. Szefler, MD Chinese University of Hong Kong Children's Hospital Colorado H Hong Kong, ROC Aurora, CO, USA G I R Y P O C * Disclosures for members of GINA Board of Directors and Science Committee can be found at www.ginasthma.com E C U D O R P E R R O R E T L A T O N O D - L A I R E T A M D E T H G I R Y P O C E Preface C U Asthma is a serious global health problem affecting all age groups. Its prevalence is increasing in many countries, D especially among children. Although some countries have seen a decline in hospitalizations and deaths from asthma, O asthma still imposes an unacceptable burden on health care systems, and on society through loss of productivity in the workplace and, especially for pediatric asthma, disruption to the family. R In 1993, the National Heart, Lung, and Blood Institute collaborated with the World Health OrganizatiPon to convene a workshop that led to a Workshop Report: Global Strategy for Asthma Management and Prevention.1 This was followed by E the establishment of the Global Initiative for Asthma (GINA), a network of individuals, organizations, and public health R officials to disseminate information about the care of patients with asthma, and to provide a mechanism to translate scientific evidence into improved asthma care. The GINA Assembly was subsequently initia ted, as an ad hoc group of R dedicated asthma care experts from many countries. The Assembly works with the Science Committee, the Board of O Directors and the Dissemination and Implementation Committee to promote international collaboration and dissemination of information about asthma. The GINA report (“Global Strategy for Asthma Manage ment and Prevention”), has been R updated annually since 2002, and publications based on the GINA reports have been translated into many languages. In 2001, GINA initiated an annual World Asthma Day, raising awareness about theE burden of asthma, and becoming a focus for local and national activities to educate families and health care professionaTls about effective methods to manage and control asthma. L In spite of these efforts, and the availability of effective therapies, internatAional surveys provide ongoing evidence for suboptimal asthma control in many countries. It is clear that if recomm endations contained within this report are to T improve care of people with asthma, every effort must be made to encourage health care leaders to assure availability of, O and access to, medications, and to develop means to implement and evaluate effective asthma management programs. N By 2012, there was increasing awareness of the heterogeneity of asthma, recognition of the spectrum of chronic airways disease, acknowledgement of major issues such as adheren ce and health literacy, and increasing interest in O individualized asthma care. In addition, a strong evidence base had emerged about effective methods for implementation of clinical guidelines. These issues meant that provision Dof a framework for asthma care was not adequate in itself: recommendations needed to be integrated into strategies that would be both clinically relevant and feasible for implementation into busy clinical practice. To this en-d, the major revision of the GINA report published in May 2014, presented recommendations in a user friendly wayL with extensive use of summary tables and flow-charts. For clinical utility, recommendations for clinical practice werAe contained in the core GINA Report, while additional resources and background supporting material were provideId online at www.ginasthma.org. The same approach has been taken with the R 2015 update of the GINA report. E It is a privilege for us to acknowledge the superlative work of all who have contributed to the success of the GINA T program, and the many people who participated in the present project. We particularly appreciate the outstanding and dedicated work by Drs Suzanne HurAd (Scientific Director) and Claude Lenfant (Executive Director) over the many years since GINA was first established.M The work of GINA is now supp orted only by income generated from the sale of materials based on the report. The D members of the GINA Committees are solely responsible for the statements and conclusions presented in this publication. They receive no honorariaE or expenses to attend the twice-yearly scientific review meetings, nor for the many hours spent reviewing the literature and contributing substantively to the writing of the report. T We hope you find thiHs report to be a useful resource in the management of asthma and that, in using it, you will recognize the need to individGualize the care of each and every asthma patient you see. I R J Mark FitzGerald, MD Helen K Reddel, MBBS PhD Y Chair, GINA Board of Directors Chair, GINA Science Committee P O C i E C U TABLE OF CONTENTS D O Methodology ...................................................................................................................................................................... vi R What’s new in GINA 2015? ................................................................................................................................................. ix P SECTION 1. ADULTS, ADOLESCENTS AND CHILDREN 6 YEARS AND OLDER ............................................................... 1 E Chapter 1. Definition, description, and diagnosis of asthma ............................................................................................. 1 R Definition of asthma .................................................................................................................................................... 2 R Description of asthma .................................................................................................................................................. 2 O Making the initial diagnosis ......................................................................................................................................... 3 R Differential diagnosis ................................................................................................................................................... 8 E Making the diagnosis of asthma in special populations .............................................................................................. 9 T Chapter 2. Assessment of asthma .................................................................L................................................................... 13 A Overview .................................................................................................................................................................... 14 T Assessing asthma symptom control .......................................................................................................................... 15 O Assessing future risk of adverse outcomes................................................................................................................ 19 N Role of lung function in assessing asthma control .................................................................................................... 19 O Assessing asthma severity ......................................................................................................................................... 21 D Chapter 3. Treating asthma to control symptoms and minimize risk .............................................................................. 23 - Part A. General principles of asthma managemen t ....................................................................................................... 24 L Long-term goals of asthma management ....A.............................................................................................................. 24 The patient-health care provider partnerIship ........................................................................................................... 25 R Control-based asthma management E......................................................................................................................... 26 T Part B. Medications and strategies for symptom control and risk reduction ............................................................... 28 A Asthma medications .................................................................................................................................................. 29 M Reviewing response and adjusting treatment ........................................................................................................... 35 D Treating other modifiable risk factors ....................................................................................................................... 38 E Non-pharmacological interventions .......................................................................................................................... 39 T Indications for reHferral for expert advice ................................................................................................................... 41 Part C. Guided aGsthma self-management education and skills training ........................................................................ 42 I Overview .................................................................................................................................................................... 42 R Skills tYraining for effective use of inhaler devices ..................................................................................................... 42 P Adherence with medications and other advice ......................................................................................................... 43 O C ii E C U Asthma information ................................................................................................................................................... 44 D Training in guided asthma self-management ............................................................................................................ 45 O Part D. Managing asthma with comorbidities and in special populations ................................................................ 47 R Managing comorbidities ............................................................................................................................................ 47 P Managing asthma in special populations or settings ...........................................................E..................................... 50 R Chapter 4. Management of worsening asthma and exacerbations ................................................................................. 57 Overview .....................................................................................................................R............................................... 59 O Diagnosis of exacerbations ........................................................................................................................................ 59 Self-management of exacerbations with a written asthma action plan ........R........................................................... 60 Management of asthma exacerbations in primary care ............................E............................................................... 63 T Management of asthma exacerbations in the emergency department ................................................................... 66 L Chapter 5. Diagnosis of asthma, COPD and asthma-COPD overlap synAdrome (ACOS) .................................................... 73 Objective ..................................................................................... ............................................................................... 74 T Background to diagnosing asthma, COPD and ACOS ...........O..................................................................................... 74 Definitions ........................................................................N.......................................................................................... 75 Stepwise approach to diagnosis of patients with resOpiratory symptoms ................................................................. 76 Future research.....................................................D..................................................................................................... 82 SECTION 2. CHILDREN 5 YEARS AND YOUNGER .. .......................................................................................................... 83 - Chapter 6. Diagnosis and management of asthLma in children 5 years and younger ...................................................... 83 A Part A. Diagnosis ............................................................................................................................................................ 84 I R Asthma and wheezing in young children ................................................................................................................... 84 E Clinical diagnosis of asthma ....................................................................................................................................... 85 T Tests to assist in diagnosis ......................................................................................................................................... 87 A Differential diagnosis .......M.......................................................................................................................................... 88 Part B. Assessment and m anagement ........................................................................................................................... 90 D Goals of asthma management ................................................................................................................................... 90 E Assessment of aTsthma ............................................................................................................................................... 90 H Medications for symptom control and risk reduction ............................................................................................... 92 G Reviewing response and adjusting treatment ........................................................................................................... 96 I R Choice of inhaler device ............................................................................................................................................ 96 Y Asthma self-management education for carers of young children ........................................................................... 97 P Part C. Management of worsening asthma and exacerbations in children 5 years and younger ................................. 98 O C iii E C U Diagnosis of exacerbations ........................................................................................................................................ 98 D Initial home management of asthma exacerbations ................................................................................................. 99 O Primary care or hospital management of acute asthma exacerbations.................................................................. 101 R Chapter 7. Primary prevention of asthma ...................................................................................................................... 105 P Factors contributing to the development of asthma ................................................................E.............................. 106 R Prevention of asthma in children ............................................................................................................................ 106 Advice about primary prevention of asthma ...................................................................R........................................ 108 SECTION 3. TRANSLATION INTO CLINICAL PRACTICE ....................................................O............................................. 109 Chapter 8. Implementing asthma management strategies into health systems ......... .................................................. 109 R Introduction .....................................................................................................E........................................................ 110 Adapting and implementing asthma clinical practice guidelines ...............T............................................................. 110 L Barriers and facilitators............................................................................................................................................ 112 A Evaluation of the implementation process ...................................... ........................................................................ 112 T How can GINA help with implementation? ...............................O.............................................................................. 112 REFERENCES .................................................................................N................................................................................... 113 O D - L A I R E T A M D E T H G I R Y P O C iv E C U TABLES AND FIGURES D Box 1-1. Diagnostic flowchart for clinical practice – initial presentation ....................................................O......................... 4 Box 1-2. Diagnostic criteria for asthma in adults, adolescents, and children 6–11 years .................................................. 5 R Box 1-3. Differential diagnosis of asthma in adults, adolescents and children 6–11 years ............................................... 8 Box 1-4. Confirming the diagnosis of asthma in a patient already taking controller treatment .......P................................. 10 Box 1-5. How to step down controller treatment to help confirm the diagnosis of asthma .............................................. 11 E Box 2-1. Assessment of asthma in adults, adolescents, and children 6–11 years .......................................................... 15 Box 2-2. GINA assessment of asthma control in adults, adolescents and children 6–11 yeaRrs ...................................... 17 Box 2-3. Specific questions for assessment of asthma in children 6–11 years ................. .............................................. 18 Box 2-4. Investigating a patient with poor symptom control and/or exacerbations despitRe treatment ............................. 22 Box 3-1. Communication strategies for health care providers ......................................................................................... 25 O Box 3-2. The control-based asthma management cycle .................................................................................................. 26 Box 3-3. Population level versus patient level decisions about asthma treatment . ......................................................... 27 R Box 3-4. Recommended options for initial controller treatment in adults and adolescents ............................................. 30 Box 3-5. Stepwise approach to control symptoms and minimize future risk .....E............................................................... 31 Box 3-6. Low, medium and high daily doses of inhaled corticosteroids........................................................................... 32 T Box 3-7. Options for stepping down treatment once asthma is well controlled ............................................................... 37 Box 3-8. Treating modifiable risk factors to reduce exacerbations ..........L........................................................................ 38 Box 3-9. Non-pharmacological interventions - Summary ......................A........................................................................... 39 Box 3-10. Indications for considering referral for expert advice, where available .............................................................. 41 Box 3-11. Strategies to ensure effective use of inhaler devices .......T................................................................................. 42 Box 3-12. Poor medication adherence in asthma .............................................................................................................. 44 O Box 3-13. Asthma information ............................................................................................................................................ 45 Box 3-14. Investigation and management of severe asthma ...N.......................................................................................... 55 Box 4-1. Factors that increase the risk of asthma-related death ..................................................................................... 59 Box 4-2. Self-management of worsening asthma in adultOs and adolescents with a written asthma action plan ............. 61 Box 4-3. Management of asthma exacerbations in primary care (adults, adolescents, children 6–11 years) ................ 64 D Box 4-4. Management of asthma exacerbations in acute care facility, e.g. emergency department .............................. 67 Box 4-5. Discharge management after hospital or emergency department care for asthma .......................................... 72 Box 5-1. Current definitions of asthma and COPD-, and clinical description of ACOS..................................................... 75 Box 5-2a. Usual features of asthma, COPD andL ACOS .................................................................................................... 77 Box 5-2b. Features that if present favor asthmAa or COPD ................................................................................................ 77 Box 5-3. Spirometric measures in asthma, COPD and ACOS ........................................................................................ 79 I Box 5-4. Summary of syndromic approacRh to diseases of chronic airflow limitation ....................................................... 81 Box 5-5. Specialized investigations sometimes used in distinguishing asthma and COPD ............................................ 82 Box 6-1. Probability of asthma diagnoEsis or response to asthma treatment in children 5 years and younger ................ 85 Box 6-2. Features suggesting a diaTgnosis of asthma in children 5 years and younger................................................... 86 Box 6-3. Common differential diagnoses of asthma in children 5 years and younger ..................................................... 89 A Box 6-4. GINA assessment of asthma control in children 5 years and younger .............................................................. 91 Box 6-5. Stepwise approach toM long-term management of asthma in children 5 years and younger ............................. 95 Box 6-6. Low daily doses of inhaled corticosteroids for children 5 years and younger ................................................... 96 Box 6-7. Choosing an inhDaler device for children 5 years and younger........................................................................... 97 Box 6-8. Primary care management of acute asthma or wheezing in children 5 years and younger ............................ 100 Box 6-9. Initial assessmEent of acute asthma exacerbations in children 5 years and younger ...................................... 101 Box 6-10. IndicationsT for immediate transfer to hospital for children 5 years and younger ............................................. 102 Box 6-11. Initial management of asthma exacerbations in children 5 years and younger ............................................... 103 H Box 7-1. Advice about primary prevention of asthma in children 5 years and younger ................................................. 108 Box 8-1. ApproGach to implementation of the Global Strategy for Asthma Management and Prevention ...................... 111 Box 8-2. Essential elements required to implement a health-related strategy ............................................................... 111 I Box 8-3. ERxamples of barriers to the implementation of evidence-based recommendations ........................................ 112 Y P O C v E C U Methodology D O GINA SCIENCE COMMITTEE R The GINA Science Committee was established in 2002 to review published research on asthma management and prevention, to evaluate the impact of this research on recommendations in GINA documents, and to pProvide yearly updates to these documents. The members are recognized leaders in asthma research and clinical practice with the E scientific expertise to contribute to the task of the Committee. They are invited to serve for a limited period and in a R voluntary capacity. The Committee is broadly representative of adult and pediatric disciplines as well as from diverse geographic regions. The Science Committee meets twice yearly in conjunction with the Amer ican Thoracic Society R (ATS) and European Respiratory Society (ERS) international conferences, to review asthma-related scientific literature. O Statements of interest for Committee members are found on the GINA website www.ginasthma.org. R PROCESSES E For each meeting of the GINA Science Committee, a PubMed search is performed using search fields established by the Committee: 1) asthma, all fields, all ages, only items with abstracts, clinicalT trial, human; and 2) asthma and meta- analysis, all fields, all ages, only items with abstracts, human. Publications frLom July 1 to December 30 are reviewed during the following ATS meeting, and those from January 1 to June 30 duAring the following ERS meeting. The respiratory community is also invited to submit to the Chair of the GINA Science Committee any other peer-reviewed T publications that they believe should be considered, providing an abstract and the full paper are submitted in (or translated into) English; however, because of the comprehensive prOocess for literature review, such ad hoc submissions have rarely resulted in substantial changes to the report. N Each abstract identified by the above search is allocated to at least two Committee members, but all members receive a O copy of all of the abstracts and have the opportunity to provide comments. Members evaluate the abstract and, by his/her judgment, the full publication, and answer four writDten questions about whether the scientific data impact on GINA recommendations, and if so, what specific changes should be made. A list of all publications reviewed by the Committee is posted on the GINA website. - L During Committee meetings, each publication that was assessed by at least one member to potentially impact on the A GINA report is discussed. Decisions to modify the report or its references are made by consensus by the full Committee, I or, if necessary, by an open vote of the full Committee. The Committee makes recommendations for therapies that have R been approved for asthma by at least one regulatory agency, but decisions are based on the best available peer- E reviewed evidence and not on labeling directives from government regulators. In 2009, after carrying out two sample reviews using the GRADE system,2 GINTA decided not to adopt this methodology for its general processes because of the major resource challenges that it Awould present. This decision also reflected that, unique among evidence based recommendations in asthma, and mMost other therapeutic areas, GINA conducts an ongoing twice-yearly update of the evidence base for its recommendations. As with all previous GINA reports, levels of evidence are assigned to management recommendationDs where appropriate. A description of the current criteria is found in Table A. Updates of the Global Strategy for Asthma Management and Prevention are generally issued in December of each year, based on E evaluation of publications from July 1 of the previous year through June 30 of the year the update was completed. T GINA 2014 H GINA 2014 represeGnted the first major revision of the strategy report since 2006. It was developed in the context of major changes in our understanding of airways disease, a focus on risk reduction as well as on symptom control, I widespread inteRrest in personalized asthma treatment, and extensive evidence about how to effectively translate and implement eYvidence into changes in clinical practice.3,4 P O C vi Methodology
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