GlaxoSmithKline and Innoviva, Inc. announced headline results from the phase 3 CAPTAIN study demonstrating that once-daily single inhaler triple therapy with fluticasone furoate, umeclidinium and vilanterol met the study’s primary endpoint of significant improvement in lung function compared with fluticasone furoate and vilanterol in patients with uncontrolled asthma.
The full results will be submitted for presentation at future scientific meetings and in peer-reviewed publications, according to a press release issued by GlaxoSmithKline.
The randomized, double-blind, active-controlled trial was designed to compare the effects of once-daily single inhaler triple therapy (Trelegy Ellipta) vs. dual therapy (Breo Ellipta, GlaxoSmithKline) in patients with uncontrolled asthma despite previous inhaled corticosteroid/long-acting beta-2 agonist (> 250 mcg/day fluticasone propionate or equivalent) maintenance medication, according to the release. In total, 2,436 patients in 15 countries were assigned to one of six treatment arms: Trelegy Ellipta 100/31.5/23 mcg, 100/62.5, 25 mcg, 200/31.25/25 mcg or 200/62.5/25 mcg or Breo Ellipta 100/25 mcg or 200/25 mcg.
According to the headline results, the study met its primary endpoint — change from baseline in trough forced expiratory volume in 1 second (FEV1) after 24 weeks of treatment — demonstrating a statistically significant 110-mL improvement for Trelegy Ellipta 100/62.5/25 mcg compared with Breo Ellipta 100/25 mcg (P < .001), and a statistically significant 92-mL improvement in trough FEV1 for Trelegy Ellipta 200/62.5/25 mcg vs. Breo Ellipta 200/25 mcg (P < .001).
The CAPTAIN study also looked at the secondary endpoint of annualized rate of moderate or severe exacerbations. The data demonstrate a 13% reduction in exacerbations with Trelegy Ellipta 100/62.5/25 mcg and 200/62.5/25 mcg vs. Breo Ellipta 100/25 mcg and 200/25 mcg. However, this finding was not statistically significant, according to the release.
The study was also designed to investigate two additional doses of Trelegy Ellipta (100/31.25/25 mcg and 200/31.25/25 mcg) vs. Breo Ellipta. Increases in trough FEV1 with these further doses were similar to the increases with the 100/62.5/25-mcg and 200/62.5/25-mcg doses, and there was no difference in exacerbation rates, according to the release.
In other results, adverse event rates were similar across the six treatment groups. The most common adverse events were nasopharyngitis (13% to 15%), headache (5% to 9%), upper respiratory tract infection (3% to 6%) and bronchitis (3% to 5%), according to the release.
The companies plan to submit the CAPTAIN study data for regulatory review after the dataset is available, Hal Barron, MD, Chief Scientific Officer and president of Research and Development at GlaxoSmithKline, said in the release.
Trelegy Ellipta (100/62.5/25 mcg) was approved by the FDA in 2017 for treatment of patients with chronic obstructive pulmonary disease. Trelegy Ellipta is also indicated in the United States to reduce COPD exacerbations in patients with a history of exacerbations.
Disclosure: Barron is an employee of GlaxoSmithKline.