Incruse Ellipta: New once-daily inhaled antimuscarinic for COPD

Incruse Ellipta (umeclidinium) is a once-daily long-acting anticholinergic bronchodilator used to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults

NICE recommends adding a LAMA to a regimen containing an inhaled long-acting beta agonist and a corticosteroid in patients who remain breathless or have exacerbations despite their existing treatment.
NICE recommends adding a LAMA to a regimen containing an inhaled long-acting beta agonist and a corticosteroid in patients who remain breathless or have exacerbations despite their existing treatment.

PHARMACOLOGY

Umeclidinium bromide is a long-acting muscarinic receptor antagonist (LAMA) which causes bronchodilation by inhibiting the binding of acetylcholine to muscarinic cholinergic receptors on smooth muscle in the airways.1

CLINICAL STUDIES

The efficacy of once-daily umeclidinium (administered via the Ellipta inhaler) was evaluated in two double-blind, placebo-controlled phase III trials involving 904 adults with COPD: a 12-week study and a 24-week study.2,3

Lung function

In both studies, statistically significant and clinically meaningful improvements in lung function, defined by change from baseline trough FEV1 (primary endpoint) at study end, were observed for umeclidinium compared with placebo (least squares mean treatment difference +127ml in the 12-week study and +115ml in the 24-week study; p<0.001 for both). The bronchodilatory effects of umeclidinium were evident from the first day of treatment and did not attenuate over time.2,3 

Umeclidinium was associated with a greater weighted mean improvement from baseline in FEV1 over 0–6 hours post-dose than placebo at study end in both the 12-week study (166ml, p<0.001) and the 24-week study (150ml, p<0.001).2,3 

Breathlessness

Investigators observed a significant improvement in transition dyspnoea index focal score at week 24 with umeclidinium compared with placebo in the longer study (p<0.001) but statistical significance was not reached at week 12 in the shorter study.2,3

Quality of life

Improvements in quality of life were also observed for umeclidinium. Patients treated with umeclidinium had a statistically significant reduction in St. George’s Respiratory Questionnaire total score compared with placebo in both studies (p<0.001).2,3

COPD exacerbations

At week 24, the probability of experiencing a COPD exacerbation was 8.9% in patients treated with umeclidinium compared with 13.7% in those receiving placebo (HR 0.6, p=0.035).3

Rescue medication

The 12-week study showed a significant reduction from baseline in use of rescue medication (salbutamol) in the umeclidinium group compared with the placebo group, with a mean reduction of 0.7 puffs per day (p=0.025). In both the 12- and 24-week studies, patients receiving umeclidinium had a higher percentage of days when no rescue medication was needed (46.3% vs 35.2% and 31.1% vs 21.7%, respectively) although no formal statistical testing was performed on this endpoint.1

Safety profile

The most frequently reported adverse effects in patients receiving umeclidinium were nasopharyngitis, upper RTI and headache.1

References

  1. Incruse Ellipta Summary of Product Characteristics, April 2014.
  2. Trivedi R et al. Eur Respir J 2014; 43: 72–81.
  3. Donohue JF et al. Respir Med 2013; 107: 1538–46.

View Incruse Ellipta drug record

Further information: GlaxoSmithKline

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