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Making the diagnosis of asthma

  • The diagnosis of asthma should be confirmed and, for future reference, the evidence documented in the patient’s notes. Depending on clinical urgency and access to resources, this should preferably be done before starting controller treatment. Confirming the diagnosis of asthma is more difficult after treatment has been started

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 forced expiratory volume in the first second (FEV1) is low, document that the FEV1/forced vital capacity (FVC) ratio is reduced. The FEV1/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:
    • FEV1 increases by more than 12% and 200 ml (in children, >12% of the predicted value) after inhaling a bronchodilator. This is called ‘bronchodilator reversibility’
    • average daily diurnal peak expiratory flow (PEF) variability* is >10% (in children,>13%)
    • FEV1 increases by more than 12% and 200 ml 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 of asthma
  • 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 2017 report

*Calculated from twice daily readings (best of three 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

Diagnostic flow-chart for asthma in clinical practice

Algorithm for the diagnosis of asthma 1280x1524

Diagnosing asthma in special populations

Patients with cough as the only respiratory symptom

  • This may be due to chronic upper airway cough syndrome (‘post-nasal drip’), chronic sinusitis, gastro-oesophageal reflux (GORD), 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 Chapter 1 of the GINA 2017 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, chronic obstructive pulmonary disease (COPD) or asthma–COPD overlap should be considered (see below)

Smokers and ex-smokers

  • Asthma and COPD may co-exist or overlap (asthma–COPD overlap), 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 asthma–COPD overlap has worse outcomes than asthma or COPD alone. Asthma–COPD overlap is not a single disease, but is likely caused by several different mechanisms. There is little good-quality evidence about how to treat these patients, as they are often excluded from clinical trials

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. If standard criteria for asthma are not met, consider other investigations. For example, if lung function is normal, repeat reversibility testing after withholding medications for >12 hours. If the patient has frequent symptoms, consider a trial of step-up in controller treatment and repeat lung function testing after 3 months. If the patient has few symptoms, consider stepping down controller treatment; ensure the patient has a written asthma action plan, monitor them carefully, and repeat lung function testing

Assessing a patient with asthma

  • Take every opportunity to assess patients with a diagnosis of asthma, particularly when they are symptomatic or after a recent exacerbation, but also when they ask for a prescription refill. In addition, schedule a routine review at least once a year

How to assess a patient with asthma

  • 1. Asthma control—assess both symptom control and risk factors:
    • assess symptom control over the last 4 weeks (see Table 1, below)
    • identify any other risk factors for poor outcomes (see Table 1, below)
    • measure lung function before starting treatment, 3–6 months later, and then periodically, e.g. at least yearly in most patients

Table 1: Assessment of symptom control and future risk

A. Level of asthma symptom control
In the past 4 weeks, has the patient had:Well controlledPartly controlledUncontrolled

Daytime symptoms more than twice/week? Yes ▢ No ▢

None of these

1–2 of these

3–4 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 outcome

Assess risk factors at diagnosis and periodically, at least every 1–2 years, particularly for patients experiencing exacerbations.

Measure FEV1 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:

  • uncontrolled asthma symptoms (as above)

  • ICS not prescribed; poor ICS adherence; incorrect inhaler technique

  • high SABA use (with increased mortality if >1 x 200-dose canister/month)

  • low FEV1, especially if <60% predicted

  • major psychological or socioeconomic problems

  • exposures: smoking; allergen exposure if sensitized

  • comorbidities: obesity; rhinosinusitis; confirmed food allergy

  • sputum or blood eosinophilia; elevated FENO in allergic adults

  • pregnancy

Other major independent risk factors for flare-ups (exacerbations) include:

  • ever being intubated or in intensive care for asthma

  • having one or more severe exacerbations in the last 12 months

Having one or more of these risk factors increases the risk of exacerbations even if symptoms are well controlled

Risk factors for developing fixed airflow limitation include lack of ICS treatment; exposure to tobacco smoke, noxious chemicals or occupational exposures; low FEV1; chronic mucus hypersecretion; and sputum or blood eosinophilia

Risk factors for medication side-effects include:

  • Systemic: frequent OCS; long-term, high dose and/or potent ICS; also taking P450 inhibitors

  • Local: high-dose or potent ICS; poor inhaler technique

† Excludes reliever taken before exercise. For children 6–11 years, also refer to the full GINA strategy for specific risk reduction strategies.
FEV1 =forced expiratory volume in the first second; ICS=inhaled corticosteroids; SABA=short-acting beta2 agonists; FENO=fractional exhaled nitric oxide.
  • 2. Treatment issues:
    • record the patient’s treatment, and ask about side-effects
    • watch the patient using their inhaler, to check their technique
    • have an open empathic discussion about adherence
    • check that the patient has a written asthma action plan
    • ask the patient about their attitudes and goals for their asthma
  • 3. Are there any comorbidities?
    • these include rhinitis, rhinosinusitis, GORD, obesity, obstructive sleep apnea, depression and anxiety
    • comorbidities should be identified as they may contribute to respiratory symptoms and poor quality of life. Their treatment may complicate asthma management

How to investigate uncontrolled asthma in primary care

Algorithm for investigating uncontrolled asthma 1280x1007

How to assess asthma control

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. Most patients should have lung function measured at least every 1–2 years, more often in children and those at higher risk of flare-ups or lung function decline. 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 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

Initial controller treatment

  • For the best outcomes, regular daily controller treatment should be initiated as soon as possible after the diagnosis of asthma is made, because:
    • early treatment with low dose inhaled corticosteroids (ICS) leads to better lung function than if symptoms have been present for more than 2–4 years
    • patients not taking ICS who experience a severe exacerbation have lower long-term lung function than those who have started ICS
    • in occupational asthma, early removal from exposure and early treatment increase the probability of recovery
  • Regular low dose ICS is recommended for all patients with a diagnosis of asthma and any of the following:
    • asthma symptoms more than twice a month
    • waking due to asthma more than once a month
    • any asthma symptoms plus any risk factor(s) for exacerbation (e.g. needing oral corticosteroid [OCS] for asthma within the last 12 months; low FEV1; ever in intensive care unit for asthma)
  • Consider starting at a higher step (e.g. medium/high dose ICS, or ICS/long-acting beta2 -agonists [LABA]) if the patient has troublesome asthma symptoms on most days; or is waking from asthma once or more a week, especially if there are any risk factors for exacerbations. Step down after asthma has been well-controlled for 3 months
  • If the initial asthma presentation is with severely uncontrolled asthma, or with an acute exacerbation, give a short course of OCS and start regular controller treatment (e.g. high dose ICS, or medium dose ICS/LABA)
  • Low, medium, and high dose categories for different ICS medications are shown in Table 2 (below)
  • Before starting initial controller treatment:
    • record evidence for the diagnosis of asthma, if possible
    • document symptom control and risk factors
    • assess lung function, when possible
    • train the patient to use the inhaler correctly, and check their technique
    • schedule a follow-up visit
  • After starting initial controller treatment:
    • review response after 2–3 months, or according to clinical urgency
    • see stepwise approach to asthma treatment algorithm for ongoing treatment and other key management issues
    • consider step down when asthma has been well-controlled for 3 months

Stepwise approach for adjusting treatment

  • 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 summarised below; for details, see full GINA 2017 report. See Table 2 (below) for ICS dose categories 

Table 2: Low, medium and high daily doses of inhaled corticosteroids (mcg)

Inhaled corticosteroid Adults and adolescents Children 6–11 years
 LowMediumHighLowMediumHigh
Beclometasone dipropionate (CFC) 200–500 >500–1000 >1000 100–200 >200–400 >400
Beclometasone dipropionate (HFA) 100–200 >200–400 >400 50–100 >100–200 >200
Budesonide (DPI) 200–400 >400–800 >800 100–200 >200–400 >400
Budesonide (nebules)       250–500 >500v1000 >1000
Ciclesonide (HFA) 80–160 >160–320 >320 80 >80–160 >160
Fluticasone furoate (DPI) 100 n.a. 200 n.a. n.a. n.a.
Fluticasone propionate (DPI) 100–250 >250–500 >500 100–200 >200–400 >400
Fluticasone propionate (HFA) 100–250 >250–500 >500 100–200 >200–500 >500
‡ Included for comparison with older literature.
CFC=chlorofluorocarbon propellant; DPI=dry powder inhaler; HFA=hydrofluoroalkane propellant.
  • Step 1: As-needed short-acting beta2 agonist 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 FEV1Other options: regular low dose ICS for patients with exacerbation risks
  • Step 2: Regular low dose ICS plus as-needed SABA:
    • other options: Leukotriene receptor antagonists (LTRA) are less effective than ICS; ICS/LABA leads to faster improvement in symptoms and FEV1 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 beclometasone dipropionate (BDP)/formoterol or budesonide/formoterol maintenance and reliever strategy is more effective than maintenance ICS/LABA with as-needed short-acting beta2 agonists (SABA)
    • other options: medium dose ICS; for adult patients with rhinitis and allergic to house dust mite (HDM) with exacerbations despite ICS, consider adding sublingual immunotherapy (SLIT), provided FEV1 is >70% predicted
    • 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); for adult patients with rhinitis and allergic to HDM with exacerbations despite ICS, consider adding SLIT, provided FEV1 is >70% predicted.
    • 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), anti-IgE (omalizumab) for severe allergic asthma ≥ years, and anti-IL5 (s.c. mepolizumab or i.v. reslizumab) 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 systemic side-effects commonly occur

Stepwise approach to asthma treatment

Algorithm for stepwise approach to asthma treatment 1280x1796

Reviewing response and adjusting treatment

  • 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
  • Sustained step-up (for at least 2–3 months): if symptoms and/or exacerbations persist despite 2–3 months of controller treatment, assess the following common issues before considering a step-up:
    • incorrect inhaler technique
    • poor adherence
    • modifiable risk factors, e.g. smoking
    • are symptoms due to comorbid conditions, e.g. allergic rhinitis
  • Short-term step-up (for 1–2 weeks) by clinician or by patient with written asthma action plan, e.g. during viral infection or allergen exposure
  • Day-to-day adjustment by patient for patients prescribed low dose beclometasone/formoterol or budesonide/formoterol as maintenance and reliever therapy

Stepping down treatment when asthma is well-controlled

  • 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 minimises side-effects:
    • choose an appropriate time for step-down (no respiratory infection, patient not travelling, not pregnant)
    • document baseline status (symptom control and lung function), provide a written asthma action plan, monitor closely, and book a follow-up visit
    • step down through available formulations to reduce the ICS dose by 25–50% at 2–3 month intervals (see Box 3-9 in full GINA 2017 report for details of how to step down different controller treatments)
    • do not completely withdraw ICS in adults or adolescents with a diagnosis of asthma unless this is needed temporarily to confirm the diagnosis of asthma. Make sure a follow-up appointment is arranged

Inhaler skills and adherence

Provide skills training for effective use of inhaler devices

  • To ensure effective inhaler use:
    • choose the most appropriate device for the patient before prescribing: consider medication, physical problems e.g. arthritis, patient skills, and cost; for ICS by pressurised metered dose inhaler, prescribe a spacer
    • check inhaler technique at every opportunity. Ask the patient to show you how they use the inhaler. Check their technique against a device specific checklist
    • correct using a physical demonstration, paying attention to incorrect steps. Check technique again, up to 2–3 times if necessary
    • confirm that you have checklists for each of the inhalers you prescribe, and can demonstrate correct technique on them
  • Information about inhaler devices and techniques for their use can be found on the GINA website (www.ginasthma.org) and the ADMIT website (www.admit-inhalers.org)

Check and improve adherence with asthma medications

  • To identify patients with adherence problems:
    • ask an empathic question, e.g. ‘Most patients don’t take their inhaler exactly as prescribed. In the last 4 weeks, how many days a week have you been taking it? 0 days a week, or 1, or 2 days [etc]?’, or ‘Do you find it easier to remember your inhaler in the morning or night?’
    • check medication usage, from prescription date, inhaler date/dose counter, dispensing records
    • ask about attitudes and beliefs about asthma and medications

Treating modifiable risk factors

  • Some examples of risk modifiers with consistent high quality evidence are:
    • guided self-management
    • use of a regimen that minimises exacerbations
    • avoidance of exposure to tobacco smoke
    • confirmed food allergy
    • for patients with severe asthma: refer to a specialist centre

Non-pharmacological strategies and interventions

  • Some examples with consistent high quality evidence are:
    • smoking cessation advice
    • physical activity
    • occupational asthma—ask all patients with adult-onset asthma about their work history
    • non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin—always ask about asthma before prescribing
  • Although allergens may contribute to asthma symptoms in sensitised patients, allergen avoidance is not recommended as a general strategy for asthma. These strategies are often complex and expensive, and there are no validated methods for identifying those who are likely to benefit
  • Some common triggers for asthma symptoms (e.g. exercise, laughter) should not be avoided, and others (e.g. viral respiratory infections, stress) are difficult to avoid and should be managed when they occur

Treatment in special populations or contexts

  • 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. Treatment of allergic rhinitis or chronic rhinosinusitis reduces nasal symptoms but does not improve 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
  • Gastro-oesophageal reflux 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 specialised 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; LTRA may also be useful. Desensitisation 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 adrenaline

Asthma flare-ups (exacerbations)

  • For discussion with patients, the word ‘flare-up’ is preferred. ‘episodes’, ‘attacks’ and ‘acute severe asthma’ are often used, but they have variable meanings, particularly for patients
  • The management of worsening asthma and exacerbations should be considered as a continuum, from self-management by the patient with a written asthma action plan, through to management of more severe symptoms in primary care, the emergency department, and in hospital

Identifying patients at risk of asthma-related death

  • These patients should be identified and flagged for more frequent review:
    • a history of near-fatal asthma requiring intubation and ventilation
    • hospitalisation or emergency care for asthma in last 12 months
    • not currently using ICS, or poor adherence with ICS
    • currently using or recently stopped using OCS (this indicates the severity of recent events)
    • over-use of SABAs, especially more than one canister/month
    • lack of a written asthma action plan
    • history of psychiatric disease or psychosocial problems
    • confirmed food allergy in a patient with asthma

Written asthma action plans

  • All patients should be provided with a written asthma action plan appropriate for their level of asthma control and health literacy, so they know how to recognise and respond to worsening asthma
  • The written asthma action plan should include:
    • the patient’s usual asthma medications
    • when and how to increase medications, and start OCS
    • how to access medical care if symptoms fail to respond
  • The action plan can be based on symptoms and/or (in adults) PEF. Patients who deteriorate quickly should be advised to go to an acute care facility or see their doctor immediately

Medication changes for written asthma action plans (see GINA Box 4–2)

  • Increase frequency of inhaled reliever (SABA, or low dose ICS/formoterol if using maintenance and reliever regimen); add spacer for pMDI
  • Increase controller: Rapid increase in ICS component up to maximum 2000 mcg BDP equivalent. Options depend on usual controller medication, as follows:
    • ICS: at least double dose, consider increasing to high dose
    • maintenance ICS/formoterol: quadruple maintenance ICS/formoterol dose (to maximum formoterol dose of 72 mcg/day)
    • maintenance ICS/salmeterol: Step up at least to higher dose formulation; consider adding separate ICS inhaler to achieve high ICS dose
    • maintenance and reliever ICS/formoterol: continue maintenance dose; increase as-needed ICS/formoterol (maximum formoterol 72 mcg/day
  • Oral corticosteroids (preferably morning dosing):
    • adults—prednisolone 1 mg/kg/day up to 50 mg, usually for 5–7 days
    • for children, 1–2 mg/kg/day up to 40 mg, usually for 3–5 days
    • tapering not needed if treatment has been given for less than 2 weeks

Management of asthma exacerbations in primary care

Algorithm for the management of exacerbations in primary care 1280x1524

Follow-up after an exacerbation

  • Take the opportunity to review:
    • the patient’s understanding of the cause of the exacerbation
    • modifiable risk factors for exacerbations, e.g. smoking
    • understanding of purposes of medications, and inhaler technique skills
    • review and revise written asthma action plan
  • Discuss medication use, as adherence with ICS and OCS may fall to 50% within 1 week after discharge
  • Comprehensive post-discharge programs that include optimal controller management, inhaler technique, self-monitoring, written asthma action plan, and regular review are cost-effective and are associated with significant improvement in asthma outcomes
  • Referral for expert advice should be considered for patients who have been hospitalised for asthma, or who re-present for acute asthma care

further information and downloads are available from…

www.ginasthma.org

Global Initiative for Asthma. Global strategy for asthma management and prevention. February 2017.

First included: June 2017.