China’s NMPA approves GSK’s Trelegy Ellipta as the first single inhaler triple therapy for adult asthma, supported by CAPTAIN trial data showing significant lung function improvement in patients uncontrolled on ICS/LABA therapy.
Written By: Pharmacally Medical News Desk
GSK plc has announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol; FF/UMEC/VI) for the maintenance treatment of asthma in adults aged 18 years and older. This expands its existing approval in chronic obstructive pulmonary disease (COPD) and makes Trelegy Ellipta the first and only single inhaler triple therapy approved in China for both asthma and COPD.
Commenting on the approval, Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology and Inflammation R&D at GSK, emphasized that early intervention with single inhaler triple therapy can improve outcomes in suitable patients with uncontrolled asthma and reduce the risk of future exacerbations.
Clinical rationale and study basis
The approval is supported by data from GSK’s CAPTAIN study (NCT02924688), which evaluated the addition of a long-acting muscarinic antagonist (LAMA) to standard inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) therapy. In patients whose asthma remained inadequately controlled on ICS/LABA, FF/UMEC/VI delivered significantly greater improvements in lung function compared with FF/VI alone.
In the trial, 2,436 patients across 15 countries were randomized to six once-daily treatment arms. Key findings showed statistically significant improvements in forced expiratory volume in one second (FEV1). Patients receiving FF/UMEC/VI 100/62.5/25 micrograms achieved a mean FEV1 improvement of 110 mL versus FF/VI 100/25 micrograms, while the 200/62.5/25 microgram dose achieved a 92 mL improvement versus FF/VI 200/25 micrograms. Both comparisons reached high statistical significance.
Addressing unmet needs in China
Asthma remains a major public health challenge in China, affecting an estimated 46 million adults. Despite established treatment guidelines, around half of patients continue to experience uncontrolled symptoms, leading to a higher risk of exacerbations and impaired quality of life. The availability of a once-daily ICS/LAMA/LABA option in a single inhaler provides a practical escalation step for patients who do not achieve adequate control on dual therapy.
Dosing and formulation
Under the NMPA approval, FF/UMEC/VI is now authorized at:
- 100/62.5/25 micrograms for both asthma and COPD
- 200/62.5/25 micrograms for asthma only
The therapy is delivered once daily via GSK’s Ellipta dry powder inhaler, combining fluticasone furoate (ICS), umeclidinium (LAMA), and vilanterol (LABA) in a single inhalation.
Reference
Trelegy Ellipta approved in China for use in adults with uncontrolled asthma, 23 January 2026, Trelegy Ellipta approved in China for use in adults with uncontrolled asthma | GSK
A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects with Inadequately Controlled Asthma, ClinicalTrials.gov ID NCT02924688, https://clinicaltrials.gov/study/NCT02924688
Lee LA, Bailes Z, Barnes N, Boulet LP, Edwards D, Fowler A, Hanania NA, Kerstjens HAM, Kerwin E, Nathan R, Oppenheimer J, Papi A, Pascoe S, Brusselle G, Peachey G, Sule N, Tabberer M, Pavord ID. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021 Jan;9(1):69-84. doi: 10.1016/S2213-2600(20)30389-1. Epub 2020 Sep 9. Erratum in: Lancet Respir Med. 2021 Feb;9(2):e18. PMID: 32918892. https://doi.org/10.1016/s2213-2600(20)30389-1