Umeclidinium bromide + vilanterol for the treatment of chronic obstructive pulmonary disease

Abstract

A solid scientific rationale and an increasing body of clinical evidence fully support the use of an antimuscarinic agent combined with a β-agonist in chronic obstructive pulmonary disease. In this article, we focus on the development of an inhaled fixed dose combination (FDC) of two 24-h bronchodilators, umeclidinium bromide and vilanterol (UMEC/VI) (ANORO). Several pivotal clinical trials have documented the impact of this combination on lung function and other outcome measures such as quality of life, dyspnea, rescue medication use and exercise capacity, with no clinically meaningful treatment-related changes in vital signs or clinical laboratory parameters. These results allow us to predict that UMEC/VI will have a role in the maintenance treatment of chronic obstructive pulmonary disease. It remains to determine its impact on exacerbations. In any case, trials comparing UMEC/VI with other dual bronchodilator FDCs, and also with inhaled corticosteroid/long-acting β-agonist FDCs, are needed to assess the advantages, if any, of UMEC/VI FDC over other therapies.

Keywords:

• COPD
• Ellipta
• fixed-dose combination
• umeclidinium bromide
• vilanterol

Financial & competing interests disclosure

M Cazzola is a member of an advisory board for GlaxoSmithKline. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Experts agree that in patients not fully controlled with one long-acting bronchodilator, optimizing bronchodilation (i.e., adding another bronchodilator with a different mechanism of action) is the preferable option.

• Fixed-dose combination (FDC) formulations of both novel and established long-acting antimuscarinic agents with long-acting β-agonists are being developed by a number of companies.

• Umeclidinium bromide and vilanterol is an inhaled FDC of two 24-h bronchodilators, the long-acting antimuscarinic agent umeclidinium bromide and the long-acting β-agonist vilanterol, developed by GlaxoSmithKline and Theravance as a once-daily treatment for chronic obstructive pulmonary disease.

• Several pivotal clinical trials have documented the impact of umeclidinium bromide and vilanterol FDC on lung function and other outcome measures such as quality of life, dyspnea, rescue medication use and exercise capacity, with no clinically meaningful treatment-related changes in vital signs or clinical laboratory parameters.

• Other work is needed to assess the advantages, if any, of umeclidinium bromide and vilanterol FDC over other therapies.