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Guidelines for assessing asthma patients, focusing on symptom control and future risk. It covers topics such as identifying asthma symptoms, confirming diagnoses, assessing symptom control, and optimizing treatment. The document emphasizes the importance of regular controller treatment, including inhaled corticosteroids, for achieving good asthma control and minimizing the risk of exacerbations.
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BASED ON THE GLOBAL STRATEGY FOR ASTHMA MANAGEMENT AND PREVENTION
© Global Initiative for Asthma
GINA Board of Directors Chair: J Mark FitzGerald, MD GINA Science Committee Chair: Helen Reddel, MBBS PhD GINA Dissemination and Implementation Committee Chair: Louis-Philippe Boulet, MD GINA Assembly The GINA Assembly includes members from 45 countries, listed on the GINA website www.ginasthma.org. GINA Program Suzanne Hurd, PhD (to Dec 2015); Rebecca Decker, BS, MSJ
Names of members of the GINA Committees are listed on page 28.
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Asthma affects an estimated 300 million individuals worldwide. It is a serious global health problem affecting all age groups, with increasing prevalence in many developing countries, rising treatment costs, and a rising burden for patients and the community. 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. Health care providers managing asthma face different issues around the world, depending on the local context, the health system, and access to resources. The Global Initiative for Asthma (GINA) was established to increase awareness about asthma among health professionals, public health authorities and the community, and to improve prevention and management through a coordinated worldwide effort. GINA prepares scientific reports on asthma, encourages dissemination and implementation of the recommendations, and promotes international collaboration on asthma research. The Global Strategy for Asthma Management and Prevention was extensively revised in 2014 to provide a comprehensive and integrated approach to asthma management that can be adapted for local conditions and for individual patients. It focuses not only on the existing strong evidence base, but also on clarity of language and on providing tools for feasible implementation in clinical practice. The report has been updated each year since then. The GINA 2016 report and other GINA publications listed on page 28 can be obtained from www.ginasthma.org.
The reader acknowledges that this Pocket Guide is a brief summary of the GINA 2016 report for primary health care providers. It does NOT contain all of the information required for managing asthma, for example, about safety of treatments, and it should be used in conjunction with the full GINA 2016 report and with the health professional’s own clinical judgment. GINA cannot be held liable or responsible for healthcare administered with the use of this document, including any use which is not in accordance with applicable local
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Asthma is a common and potentially serious chronic disease that imposes a substantial burden on patients, their families and the community. It causes respiratory symptoms, limitation of activity, and flare-ups (attacks) that sometimes require urgent health care and may be fatal. Fortunately…asthma can be effectively treated , and most patients can achieve good control of their asthma. When asthma is under good control, patients can: Avoid troublesome symptoms during day and night Need little or no reliever medication Have productive, physically active lives Have normal or near normal lung function Avoid serious asthma flare-ups (exacerbations, or attacks) What is asthma? Asthma causes symptoms such as wheezing, shortness of breath, chest tightness and cough that vary over time in their occurrence, frequency and intensity. These symptoms are associated with variable expiratory airflow, i.e. difficulty breathing air out of the lungs due to bronchoconstriction (airway narrowing), airway wall thickening, and increased mucus. Some variation in airflow can also occur in people without asthma, but it is greater in asthma. Factors that may trigger or worsen asthma symptoms include viral infections, domestic or occupational allergens (e.g. house dust mite, pollens, cockroach), tobacco smoke, exercise and stress. These responses are more likely when asthma is uncontrolled. Some drugs can induce or trigger asthma, e.g. beta-blockers, and (in some patients), aspirin or other NSAIDs. Asthma flare-ups (also called exacerbations or attacks) may occur even in people taking asthma treatment. When asthma is uncontrolled, or in some high-risk patients, these episodes are more frequent and more severe, and may be fatal. A stepwise approach to treatment , customized to the individual patient, takes into account the effectiveness of available medications, their safety, and their cost to the payer or patient. Regular controller treatment , particularly with inhaled corticosteroid (ICS)- containing medications, markedly reduces the frequency and severity of asthma symptoms and the risk of having a flare-up. Asthma is a common condition, affecting all levels of society. Olympic athletes, famous leaders and celebrities, and ordinary people live successful and active lives with asthma.
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Box 2. Features used in making the diagnosis of asthma
1. A history of variable respiratory symptoms Typical symptoms are wheeze, shortness of breath, chest tightness, cough - People with asthma generally have more than one of these symptoms - The symptoms occur variably over time and vary in intensity - The symptoms often occur or are worse at night or on waking - Symptoms are often triggered by exercise, laughter, allergens or cold air - Symptoms often occur with or worsen with viral infections 2. Evidence of variable expiratory airflow limitation - At least once during the diagnostic process when FEV 1 is low, document that the FEV 1 /FVC ratio is reduced. The FEV 1 /FVC ratio is normally more than 0.75–0.80 in adults, and more than 0.90 in children. - Document that variation in lung function is greater than in healthy people. For example: o FEV 1 increases by more than 12% and 200mL (in children, >12% of the predicted value) after inhaling a bronchodilator. This is called ‘bronchodilator reversibility’. o Average daily diurnal PEF variability* is >10% (in children, >13%) o FEV 1 increases by more than 12% and 200mL from baseline (in children, by >12% of the predicted value) after 4 weeks of anti- inflammatory treatment (outside respiratory infections) - The greater the variation, or the more times excess variation is seen, the more confident you can be of the diagnosis - Testing may need to be repeated during symptoms, in the early morning, or after withholding bronchodilator medications. - Bronchodilator reversibility may be absent during severe exacerbations or viral infections. If bronchodilator reversibility is not present when it is first tested, the next step depends on the clinical urgency and availability of other tests. - For other tests to assist in diagnosis, including bronchial challenge tests, see Chapter 1 of the GINA 2016 report. *Calculated from twice daily readings (best of 3 each time), as (the day’s highest PEF minus the day’s lowest PEF) divided by the mean of the day’s highest and lowest PEF, and averaged over 1-2 weeks. If using PEF at home or in the office, use the same PEF meter each time.
Physical examination in people with asthma is often normal, but the most frequent finding is wheezing on auscultation, especially on forced expiration.
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Patients with cough as the only respiratory symptom This may be due to chronic upper airway cough syndrome (‘post-nasal drip’), chronic sinusitis, gastroesophageal reflux (GERD), vocal cord dysfunction, or eosinophilic bronchitis, or cough variant asthma. Cough variant asthma is characterized by cough and airway hyperresponsiveness, and documenting variability in lung function is essential to make this diagnosis. However, lack of variability at the time of testing does not exclude asthma. For other diagnostic tests, see Box 2, and Chapter 1 of the GINA 2016 report, or refer the patient for specialist opinion. Occupational asthma and work-aggravated asthma Every patient with adult-onset asthma should be asked about occupational exposures, and whether their asthma is better when they are away from work. It is important to confirm the diagnosis objectively (which often needs specialist referral) and to eliminate exposure as soon as possible. Pregnant women Ask all pregnant women and those planning pregnancy about asthma, and advise them about the importance of asthma treatment for the health of both mother and baby. The elderly Asthma may be under-diagnosed in the elderly, due to poor perception, an assumption that dyspnea is normal in old age, lack of fitness, or reduced activity. Asthma may also be over-diagnosed in the elderly through confusion with shortness of breath due to left ventricular failure or ischemic heart disease. If there is a history of smoking or biomass fuel exposure, COPD or asthma-COPD overlap syndrome (ACOS) should be considered (see Chapter 5 of the GINA 2016 report). Smokers and ex-smokers Asthma and COPD may co-exist or overlap (asthma-COPD overlap syndrome, ACOS), particularly in smokers and the elderly. The history and pattern of symptoms and past records can help to distinguish asthma with fixed airflow limitation from COPD. Uncertainty in diagnosis should prompt early referral, as ACOS has worse outcomes than asthma or COPD alone. Confirming an asthma diagnosis in patients taking controller treatment : For many patients (25–35%) with a diagnosis of asthma in primary care, the diagnosis cannot be confirmed. If the basis of the diagnosis has not already been documented, confirmation with objective testing should be sought.
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Asthma control means the extent to which the effects of asthma can be seen in the patient, or have been reduced or removed by treatment. Asthma control has two domains: symptom control (previously called ‘current clinical control’) and risk factors for future poor outcomes. Poor symptom control is a burden to patients and a risk factor for flare-ups. Risk factors are factors that increase the patient’s future risk of having exacerbations (flare-ups), loss of lung function, or medication side-effects. Box 4. Assessment of symptom control and future risk A. Level of asthma symptom control
In the past 4 weeks, has the patient had : (^) controlledWell controlled^ Partly^ Uncontrolled Daytime symptoms more than twice/week? Yes No None of these
of these
of these
Any night waking due to asthma? Yes No Reliever needed* more than twice/week? Yes No Any activity limitation due to asthma? Yes No B. Risk factors for poor asthma outcomes Assess risk factors at diagnosis and periodically, particularly for patients experiencing exacerbations. Measure FEV 1 at start of treatment, after 3–6 months of controller treatment to record personal best lung function, then periodically for ongoing risk assessment. Potentially modifiable independent risk factors for exacerbations include:
Having one or more of these risk factors increases the risk of exacerbations even if symptoms are well controlled.
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What is the role of lung function in monitoring asthma? Once asthma has been diagnosed, lung function is most useful as an indicator of future risk. It should be recorded at diagnosis, 3–6 months after starting treatment, and periodically thereafter. Patients who have either few or many symptoms relative to their lung function need more investigation. How is asthma severity assessed? Asthma severity can be assessed retrospectively from the level of treatment (p14) required to control symptoms and exacerbations. Mild asthma is asthma that can be controlled with Step 1 or 2 treatment. Severe asthma is asthma that requires Step 4 or 5 treatment, to maintain symptom control. It may appear similar to asthma that is uncontrolled due to lack of treatment.
Most patients can achieve good asthma control with regular controller treatment, but some patients do not, and further investigation is needed. Box 5. How to investigate uncontrolled asthma in primary care
This flow-chart shows the most common problems first, but the steps can be carried out in a different order, depending on resources and clinical context.
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Asthma treatment is adjusted in a continuous cycle to assess , adjust treatment and review response. The main components of this cycle are shown in Box 6.
Box 6. The control-based asthma management cycle
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For the best outcomes, regular daily controller treatment should be initiated as soon as possible after the diagnosis of asthma is made, because:
Once asthma treatment has been started, ongoing decisions are based on a cycle to assess, adjust treatment and review response. The preferred treatments at each step are summarized below and in Box 7 (p14); for details, see full GINA 2016 report. See Box 8 (p 14 ) for ICS dose categories. STEP 1 : As-needed SABA with no controller (this is indicated only if symptoms are rare, there is no night waking due to asthma, no exacerbations in the last year, and normal FEV 1 ). Other options : regular low dose ICS for patients with exacerbation risks. STEP 2: Regular low dose ICS plus as-needed SABA Other options : LTRA are less effective than ICS; ICS/LABA leads to faster improvement in symptoms and FEV 1 than ICS alone but is more expensive and the exacerbation rate is similar. For purely seasonal allergic asthma, start ICS immediately and cease 4 weeks after end of exposure. STEP 3: Low dose ICS/LABA either as maintenance treatment plus as- needed SABA, or as ICS/formoterol maintenance and reliever therapy For patients with ≥1 exacerbation in the last year, low dose BDP/formoterol or BUD/formoterol maintenance and reliever strategy is more effective than maintenance ICS/LABA with as-needed SABA. Other options : Medium dose ICS Children (6–11 years) : Medium dose ICS. Other options: low dose ICS/LABA STEP 4: Low dose ICS/formoterol maintenance and reliever therapy, or medium dose ICS/LABA as maintenance plus as-needed SABA Other options : Add-on tiotropium by mist inhaler for patients ≥12 years with a history of exacerbations; high dose ICS/LABA, but more side-effects and little extra benefit; extra controller, e.g. LTRA or slow-release theophylline (adults) Children (6–11 years): Refer for expert assessment and advice. STEP 5: Refer for expert investigation and add-on treatment Add-on treatments include tiotropium by mist inhaler for patients with a history of exacerbations (age ≥12 years), omalizumab (anti-IgE) for severe allergic asthma, and mepolizumab (anti-IL5) for severe eosinophilic asthma (age ≥12 years). Sputum-guided treatment, if available, improves outcomes. Other options : Some patients may benefit from low dose OCS but long-term
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How often should patients with asthma be reviewed? Patients should preferably be seen 1–3 months after starting treatment and every 3–12 months after that, except in pregnancy when they should be reviewed every 4–6 weeks. After an exacerbation, a review visit within 1 week should be scheduled. The frequency of review depends on the patient’s initial level of control, their response to previous treatment, and their ability and willingness to engage in self-management with an action plan. Stepping up asthma treatment Asthma is a variable condition, and periodic adjustment of controller treatment by the clinician and/or patient may be needed.
Consider stepping down treatment once good asthma control has been achieved and maintained for 3 months, to find the lowest treatment that controls both symptoms and exacerbations, and minimizes side-effects.
Exacerbation risk can be minimized by optimizing asthma medications, and by identifying and treating modifiable risk factors. Some examples of risk modifiers with consistent high quality evidence are:
In addition to medications, other therapies and strategies may be considered where relevant, to assist in symptom control and risk reduction. Some examples with consistent high quality evidence are:
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Pregnancy : asthma control often changes during pregnancy. For baby and mother, the advantages of actively treating asthma markedly outweigh any potential risks of usual controller and reliever medications. Down-titration has a low priority in pregnancy. Exacerbations should be treated aggressively. Rhinitis and sinusitis often coexist with asthma. Chronic rhinosinusitis is associated with more severe asthma. For some patients with allergic rhinitis, treatment with intranasal corticosteroids improves asthma control. Obesity : to avoid over- or under-treatment, it is important to document the diagnosis of asthma in the obese. Asthma is more difficult to control in obesity. Weight reduction should be included in the treatment plan for obese patients with asthma; even 5–10% weight loss can improve asthma control. The elderly : comorbidities and their treatment should be considered and may complicate asthma management. Factors such as arthritis, eyesight, inspiratory flow, and complexity of treatment regimens should be considered when choosing medications and inhaler devices. Gastroesophageal reflux (GERD) is commonly seen in asthma. Symptomatic reflux should be treated for its general health benefits, but there is no benefit from treating asymptomatic reflux in asthma. Anxiety and depression : these are commonly seen in people with asthma, and are associated with worse symptoms and quality of life. Patients should be assisted to distinguish between symptoms of anxiety and of asthma. Aspirin-exacerbated respiratory disease (AERD): a history of exacerbation following ingestion of aspirin or other NSAIDs is highly suggestive. Patients often have severe asthma and nasal polyposis. Confirmation of the diagnosis of AERD requires challenge in a specialized center with cardiopulmonary resuscitation facilities, but avoidance of NSAIDs may be recommended on the basis of a clear history. ICS are the mainstay of treatment, but OCS may be required. Desensitization under specialist care is sometimes effective. Food allergy and anaphylaxis : food allergy is rarely a trigger for asthma symptoms. It must be assessed with specialist testing. Confirmed food allergy is a risk factor for asthma-related death. Good asthma control is essential; patients should also have an anaphylaxis plan and be trained in appropriate avoidance strategies and use of injectable epinephrine. Surgery : whenever possible, good asthma control should be achieved pre- operatively. Ensure that controller therapy is maintained throughout the peri- operative period. Patients on long-term high dose ICS, or having more than 2 weeks’ OCS in the past 6 months, should receive intra-operative hydrocortisone to reduce the risk of adrenal crisis.
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