Recently, GSK announced that the National Medical Products Administration (NMPA) of China has officially approved a new indication for fluticasone furoate/vilanterol inhalation powder — as a maintenance treatment for uncontrolled asthma in patients aged 18 years and above. This indication is applicable to patients whose condition remains inadequately controlled despite receiving treatment with inhaled corticosteroids combined with long-acting β₂ agonists (ICS/LABA).
This is another significant milestone following the drug's approval in China in 2019 for the treatment of chronic obstructive pulmonary disease (COPD), marking the official expansion of this world's first once-daily fixed-dose triple combination inhaler into the asthma treatment field.
What is Flutiform Inhalation Powder?
Flutiform inhalation powder is a compound inhalation preparation containing three active ingredients:
- Fluticasone Furoate (FF): A potent inhaled corticosteroid (ICS) that broadly inhibits various inflammatory cells and mediators, effectively controlling chronic airway inflammation;
- Umeclidinium (UMEC): Long-acting anticholinergic drugs (LAMA), which achieve bronchodilation and relieve airflow limitation by blocking M3 receptors on airway smooth muscles;
- Trivenlantrol Triphenylacetate (VI): Long-acting β₂ receptor agonists (LABA), activate β₂ receptors to relax bronchial smooth muscle, reduce the release of allergic mediators, and improve ventilation function.
These three components work synergistically to comprehensively intervene in the core pathological mechanisms of asthma across three dimensions: anti-inflammatory, bronchodilation, and ventilation improvement.
New Indication Approval Basis: CAPTAIN Phase III Clinical Study
The approval of this new indication is based on a global multi-center Phase III clinical trial——CAPTAIN StudySolid evidence.
This study enrolled a total of 2,436 adult asthma patients aged 18 years and above. All participants had received high-dose ICS/LABA (daily equivalent dose >250μg budesonide) treatment prior to enrollment, but their asthma control remained suboptimal. The study, which covered 15 countries, utilized a randomized, double-blind design, dividing patients into multiple dosage groups and two dual-combination control groups (FF/VI), with once-daily dosing. The primary endpoint was the change in forced expiratory volume in one second (FEV₁) from baseline at week 24.
- 100/62.5/25μg dose group: FEV₁ improved by an average of 110ml (95% CI: 66–153, p<0.0001);
- 200/62.5/25μg dose group: FEV₁ improved by an average of 92ml (95% CI: 49–135, p<0.0001).
Both groups were significantly better than the dual-control group, indicating that adding LAMA to ICS/LABA (i.e., triple therapy) can bring additional bronchodilation effects, further improve lung function, and is expected to reduce the risk of acute exacerbations.
Why is this approval significant?
Currently, a significant proportion of asthma patients in China still fail to achieve good control after using ICS/LABA, facing risks such as frequent symptom flare-ups, reduced quality of life, and even hospitalization due to acute exacerbations. As the first triple-combination inhaler approved in China for asthma, Flutiform (Fluorometholone Inhalation Powder) offers a new treatment option for these "difficult-to-control" patients.
ItsOnce dailyThe method of administration also helps improve patient compliance, simplify treatment regimens, and thus more effectively achieve long-term disease management.
1. Announcement on the official website of the National Medical Products Administration (NMPA) of China2. Official release by GlaxoSmithKline PLC (GSK)Disclaimer: This article aims to promote communication and exchange in pharmaceutical academia and is intended for healthcare professionals only. MedSci Medicine does not recommend any drugs and/or indications. The drug information involved in this article is for reference only and should not replace professional medical guidance in any way, nor should it be regarded as diagnostic or therapeutic advice. If you wish to learn specific disease diagnosis and treatment information, please follow the advice or guidance of your hospital doctor.
