Overview

Key points from the evidence

The content of this evidence summary was up-to-date in October 2012. See summaries of product characteristics (SPCs), British national formulary (BNF), BNF for children (BNFc) or the MHRA or NICE websites for up-to-date information.

Fluticasone/formoterol (Flutiform) is a combination inhaler containing an inhaled corticosteroid (ICS) and a long-acting beta-2 agonist (LABA). It was launched in the UK in September 2012 and is indicated for regular treatment of asthma when a combination inhaler is appropriate:

  • for people whose asthma is not adequately controlled on an ICS and an 'as required' inhaled short-acting beta-2 agonist, or

  • for people whose asthma is adequately controlled on both an ICS and a LABA.

Fluticasone/formoterol is available in 3 strengths: 50/5 micrograms, 125/5 micrograms and 250/10 micrograms. The low and medium strengths are licensed for people aged 12 years and over; the high strength for people aged 18 years and over.

Evidence from 2 published non-inferiority studies indicates that fluticasone/formoterol is non-inferior to a comparable dose of fluticasone plus formoterol in separate inhalers, and non-inferior to a fluticasone/salmeterol combination inhaler in terms of effect on lung function, as measured by FEV1 (forced expiratory volume in 1 second). Side-effect profiles were similar and no significant differences were observed in asthma exacerbations and serious adverse events, although the 2 studies were not sufficiently powered to measure these outcomes. There are currently no published studies in people with asthma who are under 18 years.

When considering using the fluticasone/formoterol combination inhaler, local decision makers will need to consider its use alongside other treatment options when an ICS plus a LABA is appropriate, in accordance with the British guideline on the management of asthma. Although the limited published data appear to suggest that the efficacy and safety of fluticasone/formoterol is similar to other ICS/LABA combination inhalers, choice of inhaler device may be important to individual patients and may need to be taken into account by decision makers.

The cost of treatment options will also be a factor for local decision-making. If a combination inhaler is chosen, NICE guidance on Inhaled corticosteroids for the treatment of chronic asthma in adults and in children aged 12 years and over (NICE technology appraisal guidance 138) recommends the least costly device that is suitable for the individual.

Key evidence

Bodzenta-Lukaszyk A, Pulka G, Dymek A et al. (2011) Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. Respiratory Medicine 105: 674–82

Bodzenta-Lukaszyk A, Dymek A, McAulay K et al. (2011) Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomised study. BMC Pulmonary Medicine 11: 28

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.