Results from a phase 3 trial evaluating Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol; GlaxoSmithKline) in patients with uncontrolled asthma showed that the single inhaler triple therapy provided a significant improvement in lung function when compared with Breo Ellipta (fluticasone furoate/vilanterol; GlaxoSmithKline).
Trelegy Ellipta is currently approved by the Food and Drug Administration (FDA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
In the CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study, patients whose asthma was inadequately controlled despite treatment with inhaled corticosteroid (ICS)/long-acting beta-2 agonist (LABA) maintenance asthma medication were randomized to receive Trelegy Ellipta or Breo Ellipta once daily. Patients were assigned to 6 different treatment arms: Trelegy Ellipta 100/31.25/25, 100/62.5/25, 200/31.25/25 or 200/62.5/25mcg, Breo Ellipta 100/25 or 200/25mcg. The primary endpoint of the study was change from baseline in trough forced expiratory volume in 1 second (FEV1) at 24 weeks; annualized rate of moderate/severe asthma exacerbations was designated as a secondary endpoint.
Results of the study showed a statistically significant 110mL improvement in trough FEV1 with Trelegy Ellipta 100/62.5/25mcg compared with Breo Ellipta 100/25mcg (P<.001, 95% CI: 66-153mL). In addition, there was a statistically significant 92mL improvement in trough FEV1 with the Trelegy Ellipta 200/62.5/25mcg dose vs Breo Ellipta 200/25mcg (P<.001, 95% CI: 49-135mL). While not considered statistically significant, Trelegy Ellipta (100/62.5/25mcg and 200/62.5/25mcg) was associated with a 13% reduction in asthma exacerbations when compared with Breo Ellipta (100/25mcg and 200/25mcg).
In addition, the study investigated 2 additional doses of Trelegy: 100/31.25/25mcg and 200/31.25/25mcg; increases in trough FEV1 were found to be of similar magnitude to those seen with the 100/62.5/25mcg and 200/62.5/25mcg doses.
According to GlaxoSmithKline, data will be submitted for regulatory review to the FDA for a potential asthma indication once the full dataset is available.
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