Introduction

The fixed-dose combination of fluticasone furoate / umeclidinium / vilanterol (trade name: Trelegy Ellipta) has been approved in Germany since November 2017 for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in adults who don't benefit enough from treatment with a corticosteroid and a long-acting beta-2 agonist. As of October 2018, this fixed-dose combination is also an option for people who don't benefit enough from a combination of a long-acting beta-2 agonist drug and a long-acting anticholinergic drug.

COPD is a condition in which the lungs have become permanently damaged and the lower airways (bronchi) are constantly narrowed. This makes it difficult to breathe. Typical symptoms include coughing, coughed-up phlegm and wheezing, as well as breathing difficulties during physical activity. Phases in which the disease suddenly gets much worse, known as flare-ups or exacerbations, are also typical. They are usually characterized by acute episodes of shortness of breath and severe coughing with sputum (phlegm). Various medications can relieve the symptoms and prevent acute breathing problems.

Umeclidinium is a long-acting anticholinergic drug, and vilanterol is a long-acting beta-2 agonist drug. Both drugs widen the airways, in different ways. Fluticasone furoate is a corticosteroid. The drugs have been approved for the long-term treatment of COPD in adults for a while – both for use on their own and as part of various combinations.

Application

The fixed-dose combination fluticasone furoate / umeclidinium / vilanterol is available as a powder that is inhaled (breathed in). It is used once a day with a dry powder inhaler.

Other treatments

Various drugs or drug combinations are available for people with moderate to severe COPD. The most suitable treatment option will depend on whether it's the person’s first treatment or which treatments have been tried before. The treatment is individually modified by the doctor. The most commonly used medications are long-acting beta-2 agonists (formoterol or salmeterol), long-acting anticholinergics (tiotropium or aclidinium bromide) and inhaled corticosteroids.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether the fixed-dose combination of fluticasone furoate / umeclidinium / vilanterol has any advantages or disadvantages for people with moderate to severe COPD when compared with individually optimized treatment using a combination of a beta-2 agonist and an anticholinergic drug and, if necessary, a corticosteroid.

The manufacturer didn't provide any suitable data on advantages or disadvantages of the triple combination when used in people who didn't benefit enough from treatment with the combination of a beta-2 agonist and an anticholinergic drug.

The manufacturer provided one study on the advantages and disadvantages of the triple combination when used in people who didn't benefit enough from the combination of a beta-2 agonist and a corticosteroid. The study involved 289 people. The people in this study were all at least 40 years old, were either smokers or ex-smokers, and had received daily COPD treatment for at least three months before the study started. One half of the patients received the fixed-dose combination fluticasone furoate / umeclidinium / vilanterol and a placebo once daily for 6 months. The other half of the patients were given the standard treatment, which in this case was a fixed-dose combination of fluticasone furoate / vilanterol, and the drug umeclidinium, too. In other words, one group took all three medications at once using one inhaler, and the other group took the same three drugs using two separate inhalers. This is what was found:

What are the advantages or disadvantages of the fixed-dose combination fluticasone furoate / umeclidinium / vilanterol?

The study found that the fixed-dose combination fluticasone furoate / umeclidinium / vilanterol had no advantages or disadvantages when compared with the combination fluticasone furoate / vilanterol plus umeclidinium.

No differences

  • Life expectancy: One person passed away during the course of the study.
  • Serious side effects: There was no difference here either. About 3 out of 100 people in each group experienced severe side effects.
  • No difference was found between the treatments regarding these aspects either:
    • Severe or very severe breathing difficulties (exacerbations)
    • Shortness of breath
    • Pneumonia
    • Quality of life
    • Treatment stopped due to side effects

What remains unanswered?

Cardiovascular diseases: The manufacturer didn’t provide any suitable data with which to look into this.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination fluticasone furoate / umeclidinium / vilanterol (Trelegy Ellipta).