Guidance

Asthma Long-acting ß2 agonists: use and safety

Published 18 December 2014

Overview

Asthma is characterised by a reversible narrowing of the airways in the lungs, which leads to a cough, wheezing, and difficulty in breathing. It can change in its severity over short periods.

Onset of asthma can occur in childhood or adulthood.

Asthma may occur as a result of:

  • an allergic reaction
  • taking other drugs (such as aspirin or non-steroidal anti-inflammatories)
  • physical exertion
  • emotional stress
  • an infection or air pollution

Avoiding factors known to cause allergies such as the house dust mite, those carried by pets, and those in food additives, and avoiding smoking helps reduce the frequency of asthma attacks.

According to Asthma UK, about 5.2 million people in the UK are receiving treatment for asthma - about one person in every 5 households.

About 2.6 million people have severe symptoms of whom about 0.5 million have asthma that is difficult to control.

Asthma can be categorised as acute or chronic. Acute asthma is a worsening of underlying asthma (characterised by a persistent shortness of breath, high pulse rate, and a low rate of breathing air out of the lungs) and needs urgent treatment.

Chronic asthma needs continual treatment to keep symptoms under control. People with mild chronic asthma have a good prognosis and rarely progress to having severe disease.

Long-acting β2 agonists (LABAs) such as formoterol and salmeterol help with the long-term control of chronic asthma. LABAs are used as add-on therapy to regular treatment with corticosteroids (for example beclometasone and fluticasone).

The benefits of LABAs outweigh their risks, and it is important that patients take their asthma medicine as prescribed to them. Patients should discuss any concerns regarding their asthma treatment with their doctor.

Treatment

Doctors treat asthma to minimise or eliminate symptoms, improve lung function and to enable patients to control their asthma, with the eventual aim of minimal treatment and side-effects of treatment.

Several different types of drugs are used to treat asthma, including those that:

  • expand the airways of the lungs (“bronchodilators”—β2 agonists, antimuscarinic bronchodilators, and theophylline)
  • reduce inflammation in the airways (corticosteroids and drugs that block the action of inflammatory molecules called leukotrienes)
  • may alleviate asthma that is the result of an allergic reaction (cromoglicate and nedocromil)

Treatment is only available on prescripton and can be given in various ways:

  • as an inhaler
  • orally
  • as an injection

Patients with chronic asthma should be treated in a stepwise manner - where treatment can be added if symptoms are not being controlled and may subsequently be reduced on control of symptoms.

The British Thoracic Society and the British National Formulary has details on the stepwise treatment of chronic asthma.

For the immediate relief of symptoms, patients with asthma are often prescribed short-acting β2 agonists (SABAs) such as:

  • salbutamol
    • Airomir
    • AirSalb
    • Asmasal
    • Pulvinal
    • Salamol
    • Salbulin
    • Ventmax
    • Ventodisks
    • Ventolin
    • Volmax
  • terbutaline
    • Bricanyl
    • that act quickly when inhaled

Patients who use short-acting β2 agonists may also benefit from regular preventer therapy in the form of corticosteroids to control inflammation of the airways.

Corticosteroids that help control asthma are:

  • budesonide (Novolizer, Pulmicort)
  • fluticasone (Flixotide)
  • mometasone (Asmanex)
  • ciclesonide (Alvesco)
  • beclometasone (Clenil, Pulvinal, Qvar

When prescribing beclometasone propionate CFC-free inhaler, doctors and any other prescribers should state clearly on the prescription which product should be dispensed by using the brand name (Clenil Modulite or Qvar).

If a pharmacist receives a generic prescription for a beclometasone dipropionate inhaler, they should establish whether a CFC-free product is required, and if so, which of the 2 available branded products should be dispensed.

Long-acting β2 agonists such as formoterol (Atimos, Foradil, Formatris, Oxis) and salmeterol (Serevent, Solmevent, Soltel, Neovent, Vertine) play a part in long-term control of chronic asthma when used as add-on therapy to regular treatment with corticosteroids. LABAs are generally recommended when regular use of standard-dose inhaled corticosteroids has failed to control asthma adequately.

Long-acting β2 agonists are also used to control nocturnal asthma (that which occurs at night or in the early hours of the morning), and can help prevent asthma symptoms associated with exercise.

Oxis may also be used for relief of short-term symptoms of airway obstruction.

Some inhalers deliver a corticosteroid and a long-acting β2 agonist together in a fixed-dose combination. These products include combinations of:

  • budesonide with formoterol (Symbicort, DuoResp)
  • fluticasone with salmeterol (Seretide)
  • fluticasone with vilanterol Relvar)
  • fluticasone with formoterol (Iffera, Flutiform)
  • beclometasone with formoterol (Fostair)

Long-acting β2 agonists should not be used without also taking regular corticosteroids. When used alone, long-acting β2 agonists have been associated with a, sometimes severe, worsening of asthma in some patients.

Low doses of long-acting β2 agonist work for most patients, therefore patients should receive the lowest dose that works for them.

Current advice

MHRA will continue to monitor the safety of asthma medicines closely. Any adverse reactions that are thought to occur as a result of treatment for asthma can be reported to the MHRA through the Yellow Card Scheme.

To ensure safe use, [Commission on Human Medicines (CHM)[(link to CHM] has advised that for the management of chronic asthma, long-acting β2 agonists (formoterol and salmeterol) should:

  • be added only if regular use of standard-dose inhaled corticosteroids has failed to control asthma adequately
  • not be initiated in patients with rapidly deteriorating asthma
  • be introduced at a low dose and the effect properly monitored before considering dose increase
  • be discontinued in the absence of benefit
  • be reviewed as clinically appropriate - stepping down therapy should be considered when good long-term asthma control has been achieved.
  • combination inhalers should be prescribed when appropriate to aid compliance

Patients should report any deterioration in symptoms after they start treatment with a long-acting β2 agonist.

Further advice for use in children

A daily dose of 24 micrograms formoterol should be sufficient for most children, particularly younger age-groups. Higher doses should be used rarely, and only when control is not maintained on the lower dose.

Long-acting β2 agonists should not be prescribed for the relief of exercise-induced asthma symptoms in the absence of regular inhaled corticosteroids (ICSs).