New once-daily triple combination inhaler for COPD

Trelegy Ellipta is licensed for the maintenance treatment of moderate to severe COPD in adults who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta₂-agonist.

Each delivered dose of Trelegy Ellipta (the dose leaving the mouthpiece) contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (as bromide) and 22 micrograms of vilanterol (as trifenatate). 

Dry powder inhaler

The three-drug combination is delivered via the breath-actuated dry powder Ellipta inhaler, which is also available as Anoro Ellipa, Incruse Ellipta and Relvar Ellipta.

There are three steps to using the Ellipta inhaler: open, inhale, close. Dose confirmation is provided by a ‘click’ sound upon opening and a reduction of one unit on the dose counter.

Patients should be advised that it may not be possible to taste or feel the medicine, even when using the inhaler correctly and to not shake the inhaler before use or block the air vents with the fingers when preparing the ‘inhale’ step.

The recommended dose of Trelegy Ellipta is one inhalation once daily, at the same time each day. The inhaler is not recommended for use in patients younger than 18 years.

Clinical studies

FULFIL was a randomised, double-blind, 24-week phase III study to compare the efficacy of once daily fluticasone/vilanterol/umeclidinium therapy (n=911) with twice daily budesonide/formoterol therapy (n=899) in patients with COPD.

The co-primary endpoints were change from baseline in trough FEV₁ and in St George’s Respiratory Questionnaire (SGRQ) total score at week 24.

At week 24, the triple combination was associated with a statistically significant improvement in lung function compared with budesonide/formoterol (mean change from baseline in trough FEV₁ of 0.142L [95% CI 0.126 to 0.158] versus -0.029L [95% CI -0.046L to -0.013L, respectively]; p<0.001).

In addition, more patients experienced noticeable improvements in their quality of life after 24 weeks with the triple combination than with the dual therapy (as indicated by a reduction in the SGRQ total score, -6.6 units versus -4.3 units, respectively; p<0.001).

The triple combination was also associated with a significant reduction in the annual rate of moderate/severe exacerbations (ie, requiring treatment with antibiotics or corticosteroids or hospitalisation) compared with dual therapy (extrapolated from data up to week 24, p=0.002).

Adverse effects

The most frequently reported adverse reactions with the triple combination were nasopharyngitis, headache and upper respiratory tract infection. Pneumonia was reported in a small number of patients and prescribers are therefore advised to monitor for signs and symptoms.