New Once-Daily LABA Improves Lung Function in COPD

 After a month of using vilanterol, an investigational long-acting beta-2-agonist (LABA) that's inhaled once a day, patients with moderate to severe chronic obstructive pulmonary disease (COPD) had significant improvements in forced expiratory volume in 1 second (FEV1).

"The 25 mcg and 50 mcg doses of vilanterol appear to offer the greatest clinical benefit without any safety concerns," the authors reported online January 12 in Chest.

Dr. Nicola A. Hanania, with Baylor College of Medicine in Houston, Texas, and colleagues note that once-daily dosing of a LABA could improve patient compliance.

To assess dose response, efficacy and safety, the researchers enrolled 602 patients with moderate-severe disease and randomly assigned them to 3.0, 6.5, 12.5, 25, or 50 mcg vilanterol, or placebo, inhaled once daily for 28 days.

The main outcome measure was the change in trough FEV1 from baseline to the end of the study. The 25 and 50 mcg doses produced clinically relevant changes of at least 130 mL, the report indicates.

Specifically, the placebo-adjusted changes in trough FEV1 were 92, 98, 110, 137, and 165 mL with the five increasing doses of vilanterol.

Regarding safety, there were no treatment-related concerns with any dose in terms of lab values or effects on blood pressure or pulse rate, Dr. Hanania and colleagues report.

"Collectively, the findings demonstrate that vilanterol is an effective, well-tolerated, and fast-acting LABA with a true 24-h bronchodilator effect," they conclude.

Vilanterol is in development by GlaxoSmithKline and Theravance for use in combination with an inhaled corticosteroid as a once-daily treatment for asthma and COPD. At last report, the companies plan to submit the combination of vilanterol and fluticasone (Relovair) for regulatory approval in the USA and Europe in mid-2012. (See Reuters Health report "GSK to file lung drug despite disappointing data," posted January 9, 2012.)

SOURCE: http://bit.ly/zEAlmp

MEDSCAPE