GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair" development programme

24-Sep-2010 - United Kingdom

GlaxoSmithKline Plc (GSK) and Theravance, Inc. announced results from a Phase II safety and efficacy study for developmental combination treatment Relovair in chronic obstructive pulmonary disorder (COPD). Relovair is an investigational drug which combines fluticasone furoate (FF; an inhaled corticosteroid or ICS) and vilanterol trifenatate (VI; a newly developed long-acting beta agonist or LABA) in a once-daily treatment for patients with COPD or asthma. The results were presented at the European Respiratory Society congress in Barcelona where GSK presented a total of 13 clinical and pre-clinical abstracts for Relovair and its individual components in COPD and asthma.

The Relovair (FFVI 400/25mcg) COPD Phase II study showed that the effect of FF/VI on heart function and safety (as measured by weighted mean heart rate) was comparable to placebo (0.6bpm; 95% confidence interval (CI): -3.9, 5.1; upper CI was below non-inferiority limit).1 The most common adverse events (FFVI; placebo) were nasopharyngitis (18%;15%), headache (15%; 5%), dizziness (5%; 5%) and candidiasis (8%;0%). In the FFVI group, 68% of the patients reported adverse events versus 50% in the placebo group.

There were no clinically relevant effects seen in laboratory measures, vital signs or additional heart assessments.

Patients treated with Relovair showed greater improvements in lung function from baseline compared with placebo (as measured by pre-dose FEV1, a standard measure of lung function) in the analysis of this secondary endpoint.1Placebo-adjusted trough FEV1 for the Relovair patients on Day 29 was 183mL (95% confidence interval (CI): 87, 279mL) and the weighted mean FEV1 for the Relovair patients on Day 28 was 236mL (95% CI: 154, 319mL).

Darrell Baker, SVP GSK Respiratory Medicines Development Centre, commented, “These Phase II data are encouraging and show potential for Relovair as the first once-a-day combination in COPD. The development programme for Relovair builds on GSK’s extensive respiratory heritage and confirms our continued commitment to bring new respiratory medicines to patients.”

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