Approach

Asthma management targets symptom control and risk reduction.[1] Control-based management relies on a continual cycle of assessing, adjusting, and reviewing response to pharmacological and non-pharmacological treatment. Risk reduction is essential because patients may continue to be at risk of moderate to severe exacerbations (even with well-controlled symptoms), may have ongoing symptoms, or may experience adverse effects associated with increasing inhaled corticosteroid doses (e.g., impacting growth). Exacerbation history is less useful because of the continued risk of severe exacerbations in patients with otherwise good symptom control. Children should be prescribed the minimum number of medications at the lowest doses that achieve good control. Good education of the patient and parent or carer is fundamental to paediatric asthma management (see Patient discussions). [ Cochrane Clinical Answers logo ] ​ Most children will have mild intermittent asthma and will not require daily therapy.

This topic covers the treatment of children aged 11 years or younger with non-acute asthma, primarily according to the stepwise approach in the GINA guideline.[1] Children aged 12 years and older are typically treated as adults, and their management should not be extrapolated to younger age groups.[1][138]​​​[139]

See Acute asthma exacerbation in children for more information about the management of acute exacerbations.

See Asthma in adults for more information about the management of children aged 12 years and older.

Stepwise therapy for long-term management

Guidelines recommend viewing asthma severity and control in a stepwise manner where medication can be stepped up or stepped down based on disease severity and control.[1][103]​​[124]​ International guidance from GINA differentiates treatment steps for children aged 0-5 and 6-11 years. However, specific guidance may vary both within and between countries.[1][8]​​[124][140]

According to GINA, step 1 covers as-needed therapy and step 2 onward covers therapy for persistent asthma, with successive steps taken based on asthma severity and control. Treatment response is typically reviewed at 2- to 3-month intervals or based on clinical need, at which point further treatment decisions are made. Only one medication should usually be changed at a time to allow its effect to be assessed.

This approach should not replace personalised clinical decision-making, which includes assessment of symptom control, risk factors, inhaler availability and correct use, treatment cost, and environmental impact.

Treatment terminology

Therapeutic options are classified as follows:[1]

  • Maintenance: medications used continuously, even when asymptomatic (i.e., frequency of administration, not drug class). Includes inhaled corticosteroid (ICS)-containing medications, leukotriene receptor antagonists (LTRA), and biologics.

  • Controller: any medication that targets both symptom control and future risk. The introduction of reliever inhalers that contain an anti-inflammatory means that this class is no longer synonymous with ICS-containing or maintenance treatment.

  • Reliever: as-needed inhalers used for rapid symptom relief or before exercise. Includes short-acting beta agonists (SABAs) and as needed ICS-formoterol and ICS-SABA combinations.

  • Anti-inflammatory reliever (AIR): inhalers that contain a low-dose ICS and rapid-acting bronchodilator. Includes budesonide-formoterol, and any ICS-salbutamol combination. AIR-only therapy is used in steps 1-2 for aged 12 years and older.

  • Maintenance and reliever therapy (MART): the use of combination ICS-formoterol inhalers every day for both maintenance and symptom relief. Includes budesonide-formoterol, but excludes ICS with other long-acting beta agonists (LABAs) or SABAs. Used in steps 3-5 for children aged 6-11 years.

GINA stepwise therapy aged 0-5 years

All children who experience wheezing episodes should be provided with a short-acting beta agonist (SABA) inhaler for symptom relief. Regular controller therapy, such as an ICS, is only started at step 2 if the child has a persistent asthma phenotype. Management then follows a stepwise approach guided by asthma severity and control. Those taking a controller medication should also take a SABA when required.

Step 1. Children with infrequent viral wheezing episodes and no or few interval symptoms

  • As-needed inhaled SABA is preferred for children aged ≤5 years with mild asthma.

  • There is insufficient evidence for the use of a daily controller.

  • Children with intermittent viral-induced wheeze despite a SABA may benefit from intermittent high-dose ICS, especially if there is underlying atopy. Short courses of ICS can also be given at the onset of viral illness.

If prescribed, ensure that the ICS is used appropriately and the child is monitored for adverse effects.

Step 2. Symptoms consistent with asthma, symptoms that are not well-controlled, or 3 or more exacerbations per year.

  • Daily low-dose ICS plus as-needed inhaled SABA is preferred.

  • An alternative is an LTRA (e.g., montelukast).

  • Intermittent high-dose ICS (as-needed or episodic) may be considered for frequent viral-induced wheezing and interval symptoms, but only after a trial of daily low-dose ICS.[1][141][142]​​[143]

If good asthma control is not achieved with an initial treatment option, trial each of the alternative step 2 treatments for 3 months before stepping up treatment. If these treatments fail to control symptoms, or exacerbations still occur, confirm that the symptoms are due to asthma, check inhaler technique and adherence, and exclude risk factors (e.g., allergen or tobacco smoke exposure) before stepping up treatment.

The treatment options in step 2 may also be given as a 3-month diagnostic trials for symptom patterns not consistent with asthma when children require a SABA reliever for 3 or more wheezing episodes each year. Referral is then required before step 3.

Step 3. Diagnosed asthma and poor control on low-dose ICS.

  • Daily medium-dose (or double low-dose) ICS, plus as-needed inhaled SABA, is preferred.

  • An alternative is daily low-dose ICS plus an LTRA (based on evidence from older children).

Clinicians should also consider specialist referral. ICS-LABA therapy is not recommended at step 3 in this age group.

Step 4. Asthma not well-controlled on medium-dose (or double ‘low-dose’) ICS.

The preferred treatment is to continue controller and reliever treatment from step 3 and refer for specialist assessment if symptom control remains poor, exacerbations persist, and adverse effects develop. Before referral, check the asthma diagnosis, check inhaler technique and adherence, and exclude risk factors (e.g., allergen or tobacco smoke exposure).

Although the best treatment has not yet been established, several options are available:

  • Higher dose ICS

  • Add-on LTRA

  • Add-on LABA

  • Add-on low dose of oral corticosteroids (for a few weeks only)

  • Add-on intermittent high-dose ICS for use at the onset of respiratory illness (if exacerbations are the main problem)

While the addition of LABAs may have a beneficial role in persistent asthma management, the response to LABAs in children is different from that reported in adults and should not be extrapolated.[144][145]​​​ [ Cochrane Clinical Answers logo ] ​​ There is a lack of evidence regarding the efficacy and safety of ICS-LABA available for the 0- to 4-year age group.[144]

GINA stepwise therapy ages 6-11 years

All children aged 6-11 years should receive ICS-containing medication as maintenance treatment and as-needed SABA as reliever therapy. ICS-formoterol is suitable for MART in steps 3 and 4, but AIR-only treatment lacks evidence for recommendation in steps 1 and 2.

Although the management described in the following stepwise approach targets symptom control, it is important to ensure risk reduction at every step through a continual cycle of assessing, adjusting, and reviewing the patient’s treatment. For example, patients may continue to be at risk of moderate to severe exacerbations despite well-controlled symptoms, may have ongoing symptoms, or may experience adverse effects associated with increasing ICS doses.

Step 1. Infrequent asthma symptoms 1-2 days/week or less.

  • The preferred treatment is as-needed SABA with low-dose ICS taken at the same time (combined or in separate inhalers).

  • Daily maintenance low-dose ICS, plus as-needed SABA, is an alternative but risks poor adherence due to the infrequent symptoms. SABA-only therapy is no longer recommended.

Step 2. Asthma symptoms 2-5 days/week.

  • The preferred treatment is regular low-dose ICS plus as-needed SABA.

  • An alternative is as-needed SABA with low-dose ICS taken at the same time (combined or in separate inhalers).

  • Another alternative is daily LTRA, but this is less effective than ICS.

Step 3. Asthma symptoms 4-5 days/week or waking due to asthma at least once a week.

  • The preferred controller options are daily medium-dose ICS, daily low-dose ICS plus LABA, or switch to MART with a very low dose of ICS-formoterol.

  • An alternative is daily low-dose ICS and LTRA, although there appears to be little evidence to support this approach.[146]​ As-needed SABA should be prescribed with all controllers except MART.

Step 4. Asthma symptoms daily or most days, waking with asthma at least once a week, and low lung function.

  • The preferred controller treatments are daily medium-dose ICS plus LABA or low-dose ICS-formoterol as MART. The child should be referred to a specialist if medium-dose ICS therapy is ineffective (not required for short courses of high-dose ICS).

  • Other options at this step include high-dose ICS-LABA, add-on tiotropium, or add-on LTRA.

  • As-needed SABA should be prescribed with all controllers except MART.

  • Children who present with an acute exacerbation may require a short course of oral corticosteroids.

Step 5. Persistent symptoms and/or exacerbations despite correct inhaler technique, good adherence with treatment at step 4, and unsuccessful trials of other controller options.

  • Specialist referral is necessary for further investigation and management.[147]

  • Continue with existing treatment until specialist assessment.

  • Options at this step include:[147]

    • Higher dose ICS-LABA

    • Add-on tiotropium

    • Add-on biological agent (e.g., omalizumab, mepolizumab, or dupilumab; availability may differ by region)

    • Add-on low-dose oral corticosteroid

If a child presents during an acute exacerbation, manage according to the Acute asthma exacerbation in children topic. Children in this age group will usually then commence maintenance therapy at step 3 or 4.[1]

Exercise-induced bronchoconstriction

A common presentation in childhood, with effective treatment allowing patients to continue recommended levels of physical activity.[1][8][148]​​[149]

For most children, exercise-induced bronchoconstriction (EIB) will reflect poor asthma control and should prompt a check of inhaler technique and adherence followed by an increase in controller treatment, as necessary.[1][8] Shortness of breath or wheezing induced by exercise may also result from comorbid obesity, lack of fitness, or inducible laryngeal obstruction.[1][150]​ 

The primary pharmacological agent for the prevention of EIB is as-needed SABA approximately 5-20 minutes before exercise. If this approach is not effective, as-needed mast cell stabilising agents (e.g., sodium cromoglicate) and/or an inhaled anticholinergic (e.g., ipratropium) can be added. For patients whose symptoms remain inadequately controlled with as-needed medication, maintenance controller therapy should be commenced. Options include daily ICS with or without LABA (including MART) and/or an LTRA; if allergic, an antihistamine can be added.[148] Regular treatment with ICS and LTRA has been shown to significantly reduce the severity of EIB in children.[151]

Non-pharmacological interventions also reduce the incidence and severity of EIB. These include sufficient warm-up exercise, dietary modification, and breathing through a face mask or scarf to pre-warm and humidify air (if exercising in cold weather).[1][148] There is insufficient evidence to recommend for or against training for the prevention of EIB.[152]

Non-pharmacological treatment

Patients should be encouraged to improve their physical fitness, be treated for coexisting allergic rhinitis, and receive education about avoiding allergens and high levels of outdoor pollution based on their disease severity.

Inhaled short-acting beta agonists (SABAs)

An inhaled SABA is the first-line therapy used to rapidly reverse airflow limitation. SABA-only therapy is still recommended for children aged ≤5 years with mild asthma (step 1). GINA recommends that older children should no longer receive a SABA without maintenance therapy at any step.[1] Use of a SABA inhaler on average more than twice a week over 1 month suggests poor asthma control (or incorrect inhaler technique) and the possible need to step up treatment.[1]

Anxiety, tachycardia, and supraventricular ectopy are associated with intermittent use.[153]​ However, when used appropriately within prescribed limits as reliever therapy, SABA therapy did not contribute to excess mortality, serious adverse events, or treatment discontinuation in children aged 12 years and older.[154] 

Inhaled corticosteroids (ICS)

The beneficial effect of ICS is established and is generally considered to outweigh the potential adverse effects.[155][156] [ Cochrane Clinical Answers logo ] ​ Adverse effects may be minimised by using the lowest dose that achieves good control, using a spacer (limiting oropharyngeal deposition), and rinsing the mouth after medication delivery.[1]​​[157][158]​ Growth should be monitored in all children who take corticosteroids.[1]

Categorisation tables are provided in international guidelines to outline the ICS dosing for options referred to as 'low dose', 'medium dose', and 'high dose'; do not assume equivalence of potency between medications in these categories, because any switch between brands may cause a clinically significant dose change.[1][8][103]​​​​​​ Maintenance ICS is associated with modest improvements in pre-bronchodilator FEV1, with the greatest benefits observed in the first year of treatment.[159]

Multiple dosing strategies have been shown to reduce exacerbation risk, allowing for treatment personalisation based on individual patient phenotypes and preferences.[160] Intermittent or as-needed ICS, as add-on therapy to SABAs, may be effective for deterioration during otherwise stable periods (e.g., at the onset of a respiratory illness in step 1).[1][124][161]​​​​​ The ICS dose should be increased gradually and cautiously according to patient response and adverse effects. When starting therapy with corticosteroids, initial low dose is as effective as initial high dose with subsequent down-titration.[162] Some children with asthma may require high doses of ICS, but these should be treated under specialist supervision to monitor for serious adverse effects.[1][163]​ To minimise adverse effects, high-dose ICS therapy should be limited to short-term use over a maximum of 3-6 months.

Increased respiratory infection has not been associated with ICS use in children.[164][165]​​ Follow-up of the Childhood Asthma Management Program (CAMP) study cohort has shown that children treated with low to medium doses of ICS as maintenance therapy are not at increased risk of cataract.[166] At medium doses, the main adverse effects are local (e.g., candidiasis) or involve a transient slowing of growth, that requires monitoring.[1] Prospective cohort studies have shown that early life exposure to ICS before age 6 years was associated with reduced height but no change in bone density during continued therapy.[167] The benefit attributable to use of ICS may exceed the potential risk of a relatively small suppression in linear growth in children with asthma.[156][168]​ 

Adrenal insufficiency is a potential complication with high cumulative doses of ICS.[169][170] Specialist pulmonary assessment should be sought before initiating this therapy. It should be noted that the manufacturer's recommended maximum dose is lower than the doses suggested in the guidelines.

Fluticasone furoate and ciclesonide have longer half-lives and more favourable adverse effect profiles than some older ICS medications. These medications have a higher budesonide equivalent when comparing doses. One Cochrane review could neither demonstrate nor refute the benefit of ciclesonide compared with budesonide and fluticasone propionate.[171] [ Cochrane Clinical Answers logo ]

Oral corticosteroids

Long-term oral corticosteroid use is less common in children/adolescents than adults (9.9% vs. 22.4%).[172] ​Short courses of oral corticosteroids may be needed to achieve control of exacerbations, while long-term low-dose oral corticosteroids may be needed as part of chronic asthma management for children with severe asthma not adequately controlled on maximal therapy.[1] It is important to monitor children/adolescents receiving oral corticosteroids for common and serious long-term systemic adverse effects.[172] Growth should be monitored in all children who take corticosteroids.[1] Oral corticosteroid bursts have been shown to decrease bone mineral accretion and increase the risk of osteopenia.[173]

In one systematic review, common adverse acute events related to oral corticosteroid use ≤14 days' duration were vomiting, behaviour change, and sleep disturbance (incidence 5.4%, 4.7%, and 4.3%, respectively).[174] Other less common but serious adverse events were infection (incidence of 0.9%), increased blood pressure (39%), hypothalamic-pituitary axis suppression (81%), and weight gain (28%).[174] Another systematic review of oral corticosteroid treatment for ≥15 days reported incidence rates for weight gain (22.4%), cushingoid features (20.6%), and growth retardation (18.9%), together with increased susceptibility to infection that could result in death.[175]

Cataracts have been reported in 15% to 35% of children receiving oral corticosteroids for more than 1 year.[166]

Long-acting beta agonists (LABAs)

Response to the addition of a LABA to an ICS differs with age, such that favourable results seen in adult cohorts should not be extrapolated to children.[144][145]​​​​​​ [ Cochrane Clinical Answers logo ]

In one randomised controlled trial of 280 children, 46% who had poorly controlled asthma and at least one grandparent who identified as black had better response to an increased dose of ICS over the addition of a LABA, conflicting with results in black adults and white people of all ages.[176] Although concerns exist about the possibility of increased exacerbations with LABAs used alone, data suggest that they are safe when used with corticosteroids.[144][177][178][179][180]​​​​​[181]​​​​​​​ [ Cochrane Clinical Answers logo ] ​​​ No evidence of benefit exists for children <4 years of age.[144] Due to safety concerns, recommendations should be adhered to strictly until there is more evidence in paediatric settings

Few studies have compared ICS in combination with different LABA medications in children under 12 years of age.[182] O​ne review of the efficacy of fluticasone with either formoterol or salmeterol found that although the salmeterol group showed clear improvements in lung function, asthma symptoms, and sleep disturbance compared with the formoterol group, the salmeterol group showed a greater improvement in PEF.[183] For children aged 4-12 years with chronic asthma, there is insufficient evidence to determine whether there are differences in the safety profiles of ICS combinations with formoterol or salmeterol.[184]

Maintenance and reliever therapy (MART)

In children aged 4 years and older with moderate to severe persistent asthma, the 2020 US asthma guidelines recommend ICS-formoterol in a single inhaler as maintenance and reliever therapy (MART).[124]​ The rapid onset of bronchodilatory effect and dose-response relationship of ICS-formoterol allows patients to use this combination as either regular therapy with a SABA reliever or as part of a MART regimen.[185]​ Guideline recommendations regarding the use of MART in children <12 years differ; GINA does not recommend MART in children with asthma aged ≤5 years and younger).[1]

ICS-formoterol should not be used as the reliever in patients treated with an alternative ICS-LABA combination as maintenance therapy.[186]

Leukotriene receptor antagonists (LTRAs)

LTRAs are available as an oral formulation, which has the potential to improve adherence.[187]

One systematic review found that LTRA monotherapy compared with placebo reduced exacerbations and increased lung function, while another reported that adding LTRA to daily ICS in adolescents and adults with persistent asthma and suboptimal control led to improved lung function and asthma control.[188][189] [ Cochrane Clinical Answers logo ] ​​ However, other reviews have reported the superiority of daily ICS over LTRA as monotherapy both in preschoolers with asthma or recurrent wheezing, and in adults and children with persistent asthma.[190][191]​​ One systematic review concluded that LTRA added to ICS does not reduce the need for rescue oral corticosteroid dosing in children and adolescents with mild to moderate asthma.[192]

Despite a lack of data to confirm the equivalence or superiority of LTRA compared with LABA as adjunctive treatment to ICS in children, data in adults suggest significantly greater improvements in asthma outcomes with the addition of a LABA to an ICS.[146] One systematic review concluded that, in children aged 4-18 years with asthma, salmeterol with fluticasone was more effective than either montelukast alone, or montelukast with fluticasone.[193] For exercise-induced asthma, LTRA monotherapy or add-on therapy to ICS may be superior to LABA in some children.[151][194]

Adverse effects of montelukast​​​

Gastrointestinal and neuropsychiatric disorders are common with LTRA use in children and young people.[195]​ The US Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have warned of potentially serious behaviour and mood-related adverse effects associated with montelukast.[196][197]​​​​ These include new-onset nightmares, behavioural problems (e.g., agitation, hyperactivity, irritability, nervousness, aggression, and headache), and suicidal ideation. Healthcare professionals are advised to consider the benefits and risks of montelukast before prescribing, to have an open discussion with parents about potential adverse effects, and to monitor for the emergence of adverse effects during treatment.[196][198]​​​​​

Good-quality evidence is lacking on the effects of deprescribing in children with established asthma, but asthma control should be monitored carefully during discontinuation.[199] In a retrospective study of more than 100 children starting LTRA (median age 5 years) the incidence of drug cessation due to neuropsychiatric adverse drug reactions was approximately 15%, with most occurring within the first 2 weeks of starting the medication.[200]

Long-acting muscarinic antagonists (LAMAs)

Tiotropium is the only LAMA licensed for the management of childhood asthma. It is appropriate for use as add-on therapy in children aged ≥6 years old with severe asthma who have experienced at least one severe asthma exacerbation in the preceding year.[1][201]​​ Few published studies have evaluated the efficacy and safety of LABAs, LTRAs, and LAMAs as add-on therapies to ICS in patients aged ≤5 years or compared the results with older age groups.[202]​ One small RCT in children aged 1-5 years found that tiotropium as add-on therapy to ICS, with or without additional controller medications, was not associated with a significant difference in asthma symptoms over 12 weeks.[203]​ For children aged ≥6 years with moderate to severe asthma, evidence suggests that triple therapy (ICS, LAMA, LABA) may be associated with fewer severe asthma exacerbations and improved asthma control.[204]

Biological therapy

GINA only recommends biological therapy for severe asthma and when existing treatment has been optimised, regardless of regulatory approvals.[1] Biologics have been shown to reduce the rates of severe exacerbations, and in some cases improve lung function (e.g., dupilumab), in children with uncontrolled severe asthma.[205][206][207][208][209]​​​ Biologics appear to reduce the number of people having asthma attacks and improve lung function to a clinically relevant level.[210][211] The availability and approval of each agent differs by region, and they should only be prescribed by specialists after checking local guidance. Most biologics are associated with a risk of hypersensitivity reactions.[209]

Add-on omalizumab

Omalizumab is a monoclonal antibody against IgE that interferes with the binding of IgE to receptors on basophils and eosinophils.[212] Can be considered in children aged 6-11 years with severe allergic asthma (i.e., evidence of allergic sensitisation and an elevated IgE serum level).[1][205][206][209][213]​​​​​ Anaphylaxis occurs in approximately 0.2%, but it is generally considered safe and effective in this patient group.[212][214]

Add-on mepolizumab

Mepolizumab is an interleukin (IL)-5 antagonist monoclonal antibody. Can be considered in children aged 6-11 years with severe eosinophilic asthma (e.g., blood eosinophils above a locally specified level).[1][209][215]​ It is effective in reducing asthma exacerbation frequency, but not quality of life or lung function.[210][216][217]

Add-on dupilumab

Dupilumab is an IL-4/IL-13 antagonist monoclonal antibody.[207][208]​ Can be considered in children aged 6-11 years with a severe eosinophilic asthma (e.g., blood eosinophils above a locally specified level) or oral corticosteroid-dependent asthma. The most frequently reported adverse events are nasopharyngitis, pharyngitis, and upper respiratory tract infection.[218]

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