Overview

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

Key points from the evidence

Aclidinium bromide (Eklira Genuair) is an inhaled long-acting muscarinic antagonist (LAMA) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). It received a European marketing authorisation in July 2012 and was launched in the UK in September 2012.

In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as needed, the NICE guideline on Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update) (NICE clinical guideline 101) advises that maintenance therapy can be provided by the following (alone or in combination, with choice depending on several factors; see guideline for details):

  • a long-acting beta2 agonist (LABA)

  • a LAMA

  • a LABA with an inhaled corticosteroid (ICS) in a combination inhaler.

Evidence from 2 phase III placebo-controlled trials (ACCORD COPD I [n=561, 12 weeks] and ATTAIN [n=828, 24 weeks]) in patients with moderate to severe COPD showed that aclidinium bromide improved disease-oriented measures of lung function over 12 and 24 weeks compared to placebo. A statistically significant improvement was seen in the primary end points; ACCORD COPD I 12-week trough FEV1 (forced expired volume in 1 second) least squares mean difference 124 ml, ATTAIN 24-week trough FEV1 least squares mean difference 128 ml, with 400 micrograms aclidinium bromide compared with placebo (both p<0.0001). These differences are around the level considered to be clinically relevant (minimum clinically important difference 100 ml).

In the 24-week study, more patients had clinically significant improvements in the patient-orientated secondary outcomes of health status and dyspnoea with aclidinium bromide than with placebo.

The number of anticholinergic adverse events seen with aclidinium bromide (such as dry mouth and constipation) was low, and similar across all groups.

The publication of longer term studies comparing patient-orientated outcomes for aclidinium bromide with other active treatments for COPD would enable its place in therapy to be more clearly established. Local decision makers will need to consider the evidence for aclidinium bromide alongside that for the other treatments for COPD. Individual patient factors and the costs and safety profile of each treatment will need to be taken into account.

Key evidence

Kerwin EM, D'Urzo AD, Gelb AF et al. (2012) Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD: Journal of Chronic Obstructive Pulmonary Disease 9: 90–101

Jones PW, Singh D, Bateman ED et al. (2012) Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. European Respiratory Journal 40: 830–6

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.