GlaxoSmithKline and Innoviva have announced that the Phase 3 CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study comparing the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI to the Relvar/Breo Ellipta FF/VI DPI in patients with uncontrolled asthma met its primary endpoint.
The CAPTAIN study, which enrolled 2,436 patients, found that patients treated with either of two doses of Trelegy experienced a statistically significant improvement in lung function compared to Relvar/Breo after 24 weeks of treatment. The study also demonstrated a reduction in moderate/severe exacerbations for patients receiving Trelegy compared to Relvar/Breo, but the reduction was not statistically significant.
Trelegy Ellipta was first approved for the treatment of COPD in a limited population of patients by the FDA in September 2017 and by the EU in November 2017. The indication was expanded to additional COPD patients in the US in April 2018 and in Europe in November 2018.Trelegy Ellipta is not currently approved for the treatment of asthma in any country.
GSK R&D Chief Scientific Officer and President Hal Barron commented, “We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available. We plan to submit these data for regulatory review after the full dataset is available.”
Innoviva VP of Respiratory Medicine Paul Meunier added, “The CAPTAIN study has shown that triple therapy in a single inhaler provides a potential new treatment option for asthma management in patients uncontrolled on ICS/LABA.”
Read the GSK and Innoviva press release.
