Key points from the evidence

Key points from the evidence

The content of this evidence summary was up-to-date in June 2013. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information.

Summary

A 48-week randomised controlled trial in 1714 adults found that beclometasone/formoterol (Fostair) given as maintenance and reliever treatment was more effective than beclometasone/formoterol maintenance treatment plus as-needed salbutamol for reducing exacerbations in adults with uncontrolled asthma. Both treatments were well tolerated but adverse drug reactions occurred more commonly with beclometasone/formoterol maintenance and reliever treatment.

Effectiveness

  • Compared with as-needed salbutamol, the time to first severe exacerbation was 75 days longer with as-needed beclometasone/formoterol (p=0.0005).

  • The yearly rate of severe exacerbations was reduced by a small but significant amount with as-needed beclometasone/formoterol (7.63 events per 100 patients per year; p<0.0001).

  • No comparisons are available with budesonide/formoterol (Symbicort) for maintenance and reliever treatment.

Safety

  • Both beclometasone/formoterol and salbutamol were well tolerated.

  • Similar numbers of patients in both groups experienced serious adverse events (3.7% with as-needed beclometasone/formoterol and 4.8% with as-needed salbutamol; p value not reported).

  • Adverse drug reactions were significantly more common with as-needed beclometasone/formoterol (4.4% compared with 2.2% for as needed salbutamol; p=0.01).

  • The particles of beclometasone in Fostair are extra fine and more potent than in standard formulations of beclometasone; 100 micrograms of extra fine beclometasone in Fostair are equivalent to 250 micrograms of standard beclometasone.

Patient factors

  • Some people with uncontrolled asthma at step 3 may prefer to follow the traditional stepped model of asthma treatment. Others may prefer to change to maintenance and reliever treatment.

  • Fostair is a pressurised metered dose inhaler.

  • Symbicort is a dry powder inhaler (Turbohaler).

Resource implications

  • A Fostair inhaler containing 120 doses costs £29.32.

  • The cost of using beclometasone/formoterol maintenance and reliever treatment is estimated to be £20.04 per month compared with £14.82 per month for beclometasone/formoterol plus as-needed salbutamol.

  • A Symbicort inhaler containing 120 doses costs £33.00 or £38.00, depending on the dose.

Key points

Fostair is a pressurised metered dose inhaler that contains beclometasone dipropionate (an inhaled corticosteroid [ICS]) and formoterol fumarate dihydrate (a long-acting beta-2 agonist [LABA]).

Fostair was licensed in 2007 for the maintenance therapy of asthma in adults aged 18 years or over; within this licensed indication Fostair is taken as regular maintenance treatment with a separate rapid-acting bronchodilator taken as-needed. In December 2012, the licence was extended to include maintenance and reliever therapy in adults, meaning that Fostair is taken as regular maintenance treatment and as needed in response to asthma symptoms.

This evidence review is based on a randomised controlled trial that compared the efficacy and safety of beclometasone/formoterol maintenance and reliever treatment with standard maintenance treatment using regular beclometasone/formoterol and as-needed salbutamol. The study included 1714 adults with uncontrolled asthma, the majority of whom were at step 3 or 4 of the British guideline on the management of asthma (SIGN guideline 101).

The study found that, compared with beclometasone/formoterol plus as-needed salbutamol, beclometasone/formoterol for both maintenance and reliever treatment statistically significantly increased the time to first severe exacerbation (the primary outcome) by 75 days (134 days versus 209 days respectively; hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.49 to 0.82; p=0.0005).

A statistically significant reduction was seen in the yearly rate of severe exacerbations per patient with maintenance and reliever treatment, compared with as-needed salbutamol (14.76 events per 100 patients per year compared with 22.39 respectively; HR 0.66, 95% CI 0.55 to 0.80; p<0.0001).

Similar numbers of patients in the as-needed beclometasone/formoterol and salbutamol groups experienced serious adverse events (32 [3.7%] and 41 [4.8%] respectively; statistical significance of difference not reported). Adverse drug reactions occurred significantly more often in patients treated with as-needed beclometasone/formoterol compared with as-needed salbutamol (38 [4.4%] compared with 19 [2.2%] respectively; p=0.01).

It is not known how the efficacy and safety of beclometasone/formoterol (Fostair) compares directly with the established budesonide/formoterol (Symbicort) maintenance and reliever treatment. More data are available to support the use of budesonide/formoterol for this indication.

The British guideline on the management of asthma advises that budesonide/formoterol (Symbicort) regular maintenance and reliever treatment is an option for selected adults at step 3 whose asthma is poorly controlled, or for selected adults at step 2 whose asthma is poorly controlled and who are taking more than 400 micrograms of beclometasone dipropionate or equivalent each day. Careful education of patients about this management strategy is required. Patients taking rescue ICS/LABA once a day or more on a regular basis should have their treatment reviewed.

Based on the results of the study, beclometasone/formoterol (Fostair) may also be an option for adults at step 3 whose asthma is poorly controlled.

Some people may prefer to follow the traditional steps of the British guideline on the management of asthma. For those at step 3, this involves increasing the dose of ICS in their current maintenance treatment, rather than switching to maintenance and reliever treatment.

The choice of treatment (maintenance and reliever therapy or the traditional stepped approach), product (beclometasone/formoterol or budesonide/formoterol) and inhaler device (pressurised metered dose inhaler or dry powder inhaler) may be important to individual patients.

Key evidence

Papi A, Corradi M, Pigeon-Francisco C et al. (2013) Beclometasone—formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. The Lancet Respiratory Medicine 1: 23–31

About this evidence summary

'Evidence summaries: new medicines' provide summaries of key evidence for selected new medicines, or for existing medicines with new indications or formulations, that are considered to be of significance to the NHS. The strengths and weaknesses of the relevant evidence are critically reviewed within this summary to provide useful information for those working on the managed entry of new medicines for the NHS, but this summary is not NICE guidance.