GlaxoSmithKline (GSK) and Theravance have released positive results from a Phase III efficacy and safety trial of fluticasone furoate(FF)/vilanterol (VI) designed to support a potential filing for an asthma indication for adults in the US.
The 12 week, double-blind, parallel group, multicentre trial was designed to evaluate the efficacy and safety of FF/VI 200/25mcg inhalation powder, FF/VI 100/25mcg inhalation powder and FF 100mcg inhalation powder, in 990 patients with moderate to severe persistent asthma.
In the trial, patients were randomised to one of the three treatments taken once-daily in the evening.
For the pre-specified primary endpoint of 0-24 hour weighted mean forced expiratory volume in one second (FEV1), FF/VI 100/25mcg showed improvement in lung function compared with FF 100mcg at the end of the 12 week treatment period.
Compared with FF/VI 100/25mcg, patients treated with FF/VI 200/25mcg had shown an additional improvement of 24ml (95% CI -37, 86).
FF/VI is indicated for regular treatment of asthma in adults and adolescents aged at least 12 years who require a combination medicinal product because their symptoms are not adequately managed with inhaled corticosteroids and ‘as-needed’ inhaled short-acting beta2-agonists.
In May, FF/VI 100/25mcg was approved in by the US Food and Drug Administration (FDA) under brand name Breo Ellipta as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The medicine is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations but it is not approved by FDA for the treatment of asthma.
The results are expected to inform GSK’s discussions with the US Food and Drug Administration (FDA) on the regulatory requirements of an asthma indication for FF/VI in the US.
GSK head of respiratory therapy area unit, R&D Dave Allen said the company has undertaken a large and comprehensive clinical programme providing data on the efficacy and safety profile for FF/VI in asthma.
"With this additional data, we will consider our next steps in relation to an asthma filing in the US," Allen said.
Image: Obstruction of the lumen of the bronchiole by mucoid exudate, goblet cell metaplasia, epithelial basement membrane thickening and severe inflammation of bronchiole. Photo: courtesy of Yale Rosen.