Key messages

• Select inhaled corticosteroids and bronchodilators in chronic obstructive pulmonary disease (COPD) and asthma based on the therapeutic effect and a confirmed diagnosis
• In persistent asthma, start with a low-dose inhaled corticosteroid (ICS). Step up or back- titrate to achieve asthma control with the lowest possible dose
• In moderate to severe COPD, initiate high-dose ICS if bronchodilators alone are insufficient. Discontinue ICS after 4–8 weeks if there is no response
• Fixed-dose combinations of an ICS and a long-acting beta₂ agonist (LABA) should not be used for initial therapy in asthma or COPD
• Use of budesonide with eformoterol (Symbicort) for maintenance and reliever therapy may suit some people with poorly controlled asthma. Fluticasone with salmeterol (Seretide) is not suitable for acute relief in asthma

While fixed-dose combinations of an inhaled corticosteroid and a LABA are increasingly popular, there is no ‘one size fits all’ approach to optimal prescribing in asthma and COPD.

Confirm the diagnosis using spirometry

Use spirometry to assess COPD and asthma symptoms

Post-bronchodilator spirometry is needed to confirm irreversible airway obstruction.[1] COPD with a significant bronchodilator response is as common as COPD with no reversibility.[2]

Diagnosing asthma requires both spirometry and clinical history.[3]

Spirometry is also recommended for monitoring lung function in both asthma and COPD.[1,3]

Treat patients with COPD but significant reversibility according to asthma guidelines

For people with clinical features of both asthma and COPD, the reversible (asthma-like) component is more responsive to treatment. Patients who remain hard to manage may benefit from referral for further diagnostic testing.

Consider referring to a respiratory physician to exclude other diagnoses and complications, especially for irreversible obstruction in people younger than 40 years, people with a smoking history of < 10 pack–years[A], or people with a rapid decline in FEV₁.[1]

[A] Multiply the number of packs of cigarettes smoked per day by the number of years the person has smoked.

Select medication according to the diagnosis

Use an inhaled corticosteroid early in persistent asthma and late in moderate to severe COPD

Stepped care starts with a short-acting bronchodilator in COPD and a low-dose inhaled corticosteroid in persistent asthma.[1,3] Stepped care allows for optimal symptom control with minimal drug therapy, while defining a suitable pathway for managing fluctuating asthma symptoms or progression of COPD.

The mainstay of asthma treatment is the inhaled corticosteroids (‘preventers’). International guidelines recommend them as part of initial treatment in persistent asthma, and there is evidence that they improve lung function, improve asthma symptoms and prevent exacerbations.[4–7]

In COPD, guidelines recommend using a short-acting bronchodilator intermittently as a first step, increasing to regular long-acting treatment (tiotropium [Spiriva] or a LABA) if necessary. Inhaled corticosteroids are only indicated in moderate to severe COPD with repeated exacerbations.[B][1]

[B] Single-ingredient inhalers containing a corticosteroid are neither TGA registered nor PBS listed for COPD.

Inhaled corticosteroids have a modest benefit in COPD

A high-dose inhaled corticosteroid (see Table 1 for dose ranges), alone or in combination with a LABA, reduces average exacerbation rates in moderate to severe COPD. In trials, treating 4 people for 1 year prevented 1 exacerbation.[8] However, it is essential to assess the benefits and harms for each individual (see ‘Discontinue inhaled corticosteroids in COPD if there is no response’ below).

There is currently no drug treatment that can slow the rate of decline in lung function in COPD.

Table 1. Daily adult inhaled corticosteroid dose equivalents[C][3]

[C] Doses as labelled: ex-actuator dose for ciclesonide, and ex-valve dose for others.

Tailor the inhaled corticosteroid dose to the condition and the patient

Low-dose inhaled corticosteroid is highly effective in mild to moderate persistent asthma

More than 90% of people with asthma who see a GP have intermittent or mild to moderate persistent asthma, according to Australian survey data.[9] Low-dose inhaled corticosteroids are highly effective in this population — higher doses add little benefit and increase adverse effects.[10] On the other hand, people with severe asthma may require high-dose inhaled corticosteroid.[3]

To ensure the lowest exposure to inhaled corticosteroid adverse effects, step up only when necessary and back-titrate when symptoms are stable.

Initiate an inhaled corticosteroid at a high dose in moderate to severe COPD when there are repeated exacerbations

In COPD, all trials of inhaled corticosteroids have used moderate to high doses.[8] As the adverse effects associated with higher inhaled corticosteroid doses can be serious (including higher rates of pneumonia among COPD patients), inhaled corticosteroids should not be considered for patients with mild COPD.[1] (See the NPS RADAR review ‘Fluticasone with salmeterol [Seretide] for chronic obstructive pulmonary disease’.)

Do not initiate therapy with a combination inhaler

Use a combination when both components are indicated

Fixed-dose combination inhalers containing an inhaled corticosteroid and a LABA (i.e. Seretide and Symbicort) are an option when guidelines recommend stepping up to a combination (see Table 2).

Table 2. When to start combination therapy with an inhaled corticosteroid and a long-acting bronchodilator in asthma and COPD

[D]   Fluticasone with salmeterol (Seretide 250/25 MDI and Seretide 500/50 DPI strengths only) is PBS listed for COPD in people with FEV₁ < 50% predicted who have a history of repeated exacerbations despite regular beta₂ agonist treatment. Budesonide with eformoterol (Symbicort) is neither TGA registered nor PBS listed for COPD.

When starting a fixed-dose combination, take care with the strength

PBS data from 2002–4 show that > 50% of people received prescriptions for inhaled corticosteroids in the highest-strength category (e.g. fluticasone with salmeterol [Seretide] 500/50).[11] Starting with a high-strength inhaled corticosteroid may benefit a small proportion of people with severe asthma, but unnecessarily increases the risk of steroid-related adverse effects for those whose symptoms are milder.

Unlike in asthma, a high starting dose of inhaled corticosteroid is recommended in COPD (see Table 3).[1]

Table 3. Which combination inhaler is PBS listed for which condition?

[F] Also suitable for maintenance and reliever regimen.

[G] Not to be used by patients < 18 years old.

Test lung function and check symptoms regularly

Review is important for optimising medicine use

Review asthma patients 6–12 weeks after adjusting therapy.[3] Review visits are supported through the Asthma Cycle of Care program.

Adults with good asthma control and established medication needs, or children with intermittent asthma, may only require yearly review.[3] If asthma symptoms follow a seasonal pattern, a review scheduled before the usual time that they worsen can help ensure appropriate use of maintenance medication.

Review COPD patients 4–8 weeks after changing or stepping up therapy.[1] Lack of response to inhaled therapies in COPD is common and a prompt review allows the best therapy option to be found.

Use spirometry and ask about symptoms

Monitor using both an objective test of lung function (spirometry) and by asking about symptoms. Record functional limits as well as the frequency of symptoms to compare disease severity from visit to visit.

A brief questionnaire or checklist, such as the Asthma Control Questionnaire or the Medical Research Council dyspnoea score is useful for eliciting and grading symptoms and their impact. See NPS News 58: Inhaled corticosteroids and long-acting beta₂ agonists in asthma and COPD.

Back-titrate to the lowest dose of inhaled corticosteroid in asthma

Back-titrate when asthma symptoms have been stable for 6–12 weeks

Consider stepping down medication by reducing the inhaled corticosteroid dose by 25% to 50% or, if using combination therapy with the lowest inhaled corticosteroid dose, by stopping the LABA.[3]

Trials have found that people with stable asthma can step down high-dose inhaled corticosteroid (alone or in combination with a LABA) without worsening symptoms, including exacerbations (over 1 year of follow-up).[12]

Step down the inhaled corticosteroid dose by changing the number of puffs or prescribing a lower-strength inhaler

When using inhaled corticosteroid monotherapy, or combination therapy with separate inhaled corticosteroid and LABA inhalers, the inhaled corticosteroid dose can often be stepped down by reducing the number of puffs used per day.

When necessary, back-titrate the inhaled corticosteroid by switching the patient to a new prescription of an inhaler containing a lower strength. Fixed-dose combination inhalers offer limited flexibility in adjusting the number of puffs per day because the LABA component has only a small recommended dose range (eformoterol 12–48 micrograms daily[H] and salmeterol 100–200 micrograms daily).[13,14]

[H] Up to 72 micrograms when using the SMART regimen.

Discontinue inhaled corticosteroids in COPD if there is no response

Many people with COPD show no clinical benefit from inhaled corticosteroids

In view of the risk of serious adverse effects, high-dose inhaled corticosteroids should be stopped if there is no clinical benefit after 4–8 weeks. COPD trials have found an increased risk of pneumonia with these doses[15,16] but no statistically significant increase in mortality.[8,16] Rates of inhaled corticosteroid–related candidiasis, dysphonia and bruising were also increased in COPD trials.[8,15,16]

Check inhaler technique, smoking status and compliance

Ask patients to bring their inhalers with them to review appointments

Ability to use an inhaler can decline within 2 months of first instruction.[17] The most reliable test of inhaler technique is to ask patients to demonstrate it.

Give brief counselling for smoking cessation

Stopping smoking is the single most important intervention in COPD.[1] Smoking also worsens asthma symptoms and accelerates declining lung function.[3]

Brief counselling by a GP increases quit rates.[18] Offer pharmacotherapy and/or referral if intensive intervention is needed. See NPS News 45: Managing COPD and preventing progression.

Ask how many times a week the patient forgets a dose

Few people with asthma or COPD use their maintenance medication every day.[11] Educating patients about their disease and the purpose of their medication can help to improve compliance.[19]

If a person forgets to use their inhaler regularly, advise on ways to incorporate it into daily activities. For example, suggest using the inhaler immediately before they clean their teeth (this also saves time rinsing excess drug from the mouth and throat).

Budesonide with eformoterol (Symbicort) maintenance and reliever regimen for asthma (SMART)

Consider this alternative dosing regimen only for adults and adolescents with poorly controlled asthmaand reliever regimen for asthma (SMART)

SMART is only indicated for people with frequent asthma symptoms despite conventional combination therapy or corticosteroids alone. It is not recommended for children under 12 years.[13]

The regimen uses Symbicort for ‘single inhaler therapy’, that is, for both maintenance dosing and on-demand for acute asthma symptoms. Double-blind trials in people with poorly controlled asthma found this regimen reduced severe asthma exacerbations compared with a conventional regimen.[20–23]

Unlike in asthma, there is no evidence to support the use of on-demand combination therapy in COPD.

Fluticasone with salmeterol (Seretide) cannot be used on demand

The new regimen uses the Symbicort inhaler instead of a short-acting beta₂ agonist (SABA) ‘reliever’ (e.g. salbutamol). Eformoterol provides bronchodilation as quickly as a SABA.[24]

Fluticasone with salmeterol (Seretide) cannot be used in this way because the onset of action for salmeterol is too slow.[24]

Use this new regimen only in conjunction with a special Asthma Action Plan

Patients need to be taught how to follow the new regimen and associated Asthma Action Plan. Suitable templates are available online (at www.nationalasthma.org.au/html/management/action_plans/ap005.asp).

Assess patients for their ability to monitor asthma symptoms and on-demand inhaler use before selecting them for the maintenance and reliever regimen.

Reviewers

Prof Peter Frith
Head of Southern Respiratory Services
Repatriation General Hospital, Daw Park, SA

Prof John Wilson
Chair, National Asthma Council Australia
Department of Allergy, Immunology & Respiratory Medicine
The Alfred Hospital, Melbourne

References

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