Treatment with the triple-combination therapy Trelegy Ellipta reduced exacerbations in chronic obstructive pulmonary disease (COPD) and improved patients’ lung function and quality of life, according to a Phase 3 trial.
Findings from the study, titled “Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD,” were recently published in the New England Journal of Medicine.
The treatment, marketed by GSK, contains the inhaled corticosteroid fluticasone furoate, the long-acting muscarinic antagonist umeclidinium, and the long-acting beta2-adrenergic agonist (LABA) vilanterol.
The IMPACT study (NCT02164513) compared Trelegy Ellipta with GSK’s once-daily COPD therapies Breo Ellipta (fluticasone furoate/vilanterol) and Anoro Ellipta (umeclidinium/vilanterol). All three treatments were delivered in the same dose and inhaler.
Patients enrolled in the trial had moderate to very severe COPD and a history of exacerbations in the previous 12 months. The trial’s more than 10,000 patients were from 1,035 study centers globally.
Results revealed that treatment with the triple therapy Trelegy Ellipta significantly reduced the number of COPD hospitalizations due to severe exacerbations by 34% compared to Anoro Ellipta. Compared to Breo Ellipta, the reduction was of 13%, but this difference was not statistically significant.
The data also showed that Trelegy and Breo, the two medications containing the corticosteroid fluticasone furoate, lowered the risk of on-treatment mortality compared to Anoro.
Specifically, Trelegy decreased this risk by 42.1% compared to Anoro. However, off-treatment data should be analyzed to fully understand the benefits in mortality risk, the team emphasized.
Results further revealed improvements in other clinically relevant parameters, including lung function and health-related quality of life. Additional results will be presented at future scientific meetings.
“Reducing exacerbations to keep patients out of hospital is a key goal of COPD management alongside improving lung function and quality of life,” Dave Allen, head of Respiratory Therapy Area Research and Development at GSK, said in a press release. “The IMPACT study shows how Trelegy Ellipta can help patients with a history of exacerbation achieve these goals.”
Ted Witek, senior vice president and chief scientific officer at Innoviva, said that the “role of inhaled corticosteroids (ICS) in COPD have long been debated, and this landmark trial provides further evidence of their benefit in the population studied and compelling data towards clarifying the role of ICS containing regimens in the COPD treatment paradigm.”
The trial also showed that Trelegy had a similar safety profile as its individual components. Among the most frequent adverse events in the study were viral upper respiratory tract infection, COPD worsening, pneumonia, and headache.
In February 2018, GSK and Innoviva submitted results from the IMPACT study to the European Medicines Agency to support the label expansion of Trelegy Ellipta for European patients with moderate to severe COPD who are at risk of an exacerbation and require triple therapy. A similar submission was filed in the U.S.