One inhaler containing three drugs used once a day appears to be superior than existing dual therapy for patients with chronic obstructive pulmonary disease, according to a major trial.
The combination of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA) and a long-acting β2-agonist (LABA) resulted in fewer exacerbations and admissions, said researchers.
“The study clarifies which type of patient gains greatest benefit from each class of medicine”
The results from the IMPACT study, one of the biggest ever conducted in patients with COPD with a history of exacerbations, were revealed at the end of last week.
The study is the first to directly compare three commonly-used COPD combination treatment classes delivered using the same dose and inhaler.
It involved 10,355 COPD patients from 37 countries and compared 52 weeks of once-daily treatment with triple therapy – marketed as Trelegy Ellipta – compared to two dual therapy combinations.
The triple therapy consisted of fluticasone furoate – an inhaled glucocorticoid – at a dose of 100μg, the LAMA umeclidinium at a dose of 62.5μg, and the LABA vilanterol at a dose of 25μg.
This was compared with fluticasone furoate–vilanterol – at doses of 100μg and 25μg, respectively – and umeclidinium–vilanterol – at doses of 62.5μg and 25μg, respectively.
Each regimen was administered in a single Ellipta dry powder inhaler manufactured by GSK. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment.
“Nurses will play a key role in identifying appropriate patients for triple therapy”
The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, said the researchers. This was compared with 1.07 per year in the fluticasone furoate-vilanterol group and 1.21 per year in the umeclidinium-vilanterol group.
Meanwhile, the annual rate of severe exacerbations resulting in hospital admission in the triple-therapy group was 34% lower – at 0.13 compared with 0.19 in the umeclidinium-vilanterol group.
There was a higher incidence of pneumonia in the inhaled-glucocorticoid groups than in the umeclidinium-vilanterol group, and the risk of clinician-diagnosed pneumonia was significantly higher with triple therapy than with umeclidinium-vilanterol.
“Triple therapy with fluticasone furoate, umeclidinium, and vilanterol resulted in a lower rate of moderate or severe COPD exacerbations than fluticasone furoate-vilanterol or umeclidinium- vilanterol in this population,” said the study authors.
“Triple therapy also resulted in a lower rate of hospitalisation due to COPD than umeclidinium-vilanterol,” they said in the New England Journal of Medicine.
Study author Dr Fernando Martinez, from the New York-Presbyterian Hospital and Weill Cornell Medical Center, said the trial “significantly advances our understanding of COPD management”.
“By comparing various combinations of effective medications in the same device, the study clarifies which type of patient gains greatest benefit from each class of medicine,” he said.
“As many patients experience frequent exacerbations or ‘flare ups’, which can often result in hospitalisation, these data will be highly relevant to patients and clinicians as they consider the optimal treatment,” he added.
Dr Martinez noted that the safety profile of single inhaler triple therapy was consistent with that of the individual components. The most common adverse events were viral upper respiratory tract infection, worsening of COPD, upper respiratory tract infection, pneumonia and headache.
Nurse Monica Fletcher, a global medical expert for GSK and research fellow at Edinburgh University, said: “Nurses play a key role in the care of patients with COPD and this study has the potential to change the future of management of up to 50% of patients living with this condition.
“Exacerbations are frightening for both patients and their families and unfortunately moderate and severe exacerbations are a strong predictor of future decline in health status,” she said. “Avoiding hospital admissions, where possible and keeping patients as well as possible at home is the ultimate aim.
She added: “Nurses will play a key role in identifying appropriate patients for triple therapy and educating them about the importance of taking their treatment on a regular basis to improve their future health outcomes.”
Trelegy Ellipta was approved for use in Europe in November 2017 as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.