Combo Asthma Drug Improves Lung Function in Phase III Study
Fluticasone furoate/vilanterol meets primary endpoint (December 6)
Positive results have been reported from a phase III efficacy and safety study of the investigational drug fluticasone furoate (FF)/vilanterol (VI) (GlaxoSmithKline/Theravance, Inc.). The study was designed to support a potential filing for an asthma indication for adults in the U.S.
For the prespecified primary endpoint of the 0- to 24-hour mean forced expiratory volume in 1 second (FEV1), FF/VI 100/25 mcg demonstrated a statistically significant improvement in lung function compared with FF 100 mcg (mean improvement, 108 mL; P < 0.001) at the end of the 12-week treatment period. In patients receiving FF/VI 200/25 mcg, an additional mean improvement of 24 mL was observed compared with FF/VI 100/25 mcg.
While FF/VI (Breo Ellipta) is approved in the U.S. for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD in patients with a history of exacerbations, FF/VI is not an FDA-approved treatment for asthma.
The most common adverse effects across all treatment arms included headache, nasopharyngitis, upper respiratory tract infection, and influenza. The incidences of on-treatment serious adverse events across all treatment arms were similar (FF 100 mcg: < 1%; FF/VI 100/25 mcg: 1%; and FF/VI 200/25 mcg: < 1%).
The 12-week, double-blind, parallel-group trial was conducted to assess the efficacy and safety of FF/VI 200/25 mcg inhalation powder, FF/VI 100/25 mcg inhalation powder, and FF 100 mcg inhalation powder in 990 patients with moderate to severe persistent asthma. Patients were randomly assigned to one of the three treatments taken once-daily in the evening. The primary endpoint was the weighted mean serial FEV1 at the end of the 12-week treatment period. The primary comparison was FF/VI 100/25 mcg versus FF 100 mcg.
FF is an inhaled corticosteroid, and VI is a long-acting beta2 agonist (LABA). The combination product is administered via the Ellipta dry-powder inhaler.
Source: GSK; December 6, 2013.