chronic obstructive pulmonary disease

Less-Frequent Therapy Better for COPD Lung Function, Quality of Life

Once-daily triple therapy with luticasone furoate, umeclidinium, and vilanterol improves lung function and health-related quality of life vs twice-daily dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy among patients with chronic obstructive pulmonary disease (COPD), according to a recent study.

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Few clinical trials have compared triple therapy with ICS/LABA therapy in patients with COPD. Therefore, the researchers conducted the FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial.

To more thoroughly compare the effects of each treatment, the researchers assessed 1810 patients with COPD who were randomly assigned to receive 24 weeks of either once-daily triple therapy (n = 911) or twice-daily ICS/LABA therapy (n = 899).

Triple therapy was administered once-daily with the ELLIPTA inhaler at a dose of 100 μg fluticasone furoate, 62.5 μg umeclidinium, and 25 μg vilanterol. ICS/LABA therapy was administered twice-daily with the Turbuhaler at a dose of 400 μg budesonide and 12 μg formoterol. Additionally, a patient subgroup continued to receive blinded treatment for up to 52 weeks.

The researchers defined the primary outcomes as changes from baseline in trough Forced Expiratory Volume in one second (FEV1) and in St George Respiratory Questionnaire (SGRQ) total score at week 24.

Ultimately, the researchers observed statistically significant differences between groups for both primary outcomes. Mean changes in FEV1 from baseline were 142 ml in patients on triple therapy and -29 ml in patients on ICS/LABA therapy. Additionally, mean changes in SGRQ scores from baseline were -6.6 units in the triple therapy group and -4.3 units in the ICS/LABA group.

The researchers noted a statistically significant 35% reduction in moderate to severe exacerbation rates with triple therapy, compared with dual ICS/LABA therapy. Furthermore, the safety profile of triple therapy reflected the known profiles of each component of the therapy.

“These results support the benefits of single-inhaler triple therapy compared with ICS/LABA therapy in patients with advanced COPD,” the researchers concluded.

—Christina Vogt


Lipson DA, Barnacle H, Birk R, et al. FULFIL trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196(4).