Experimental Once-Daily COPD Treatment Promising

April 23, 2013

ZURICH (Reuters) Apr 23 - Drugmaker Novartis said today its investigational once-daily dual bronchodilator QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) was more effective at reducing chronic obstructive pulmonary disease (COPD) exacerbations than glycopyrronium 50 mcg and open-label tiotropium 18 mcg, a treatment with established efficacy in preventing exacerbations.

The SPARK study is the first to evaluate the effect on exacerbations of dual bronchodilation with a fixed-dose combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), versus single LAMA therapies, the company said.

"We are delighted that results from SPARK demonstrated that QVA149 reduced the overall rate of exacerbations in patients with severe and very severe COPD. For physicians and their patients, these findings offer hope of a new effective treatment to prevent debilitating COPD exacerbations and improve health-related quality of life," said Tim Wright, Global Head of Development at Novartis Pharma AG.

SPARK was a 64-week, multicenter, double-blind, parallel-group, active controlled study with the primary objective to show superiority of QVA149 versus glycopyrronium 50 mcg for the rate of moderate to severe COPD exacerbations in 2,224 patients with severe to very severe COPD.

The key secondary objective was to show superiority of QVA149 compared with open label tiotropium 18 mcg with respect to the rate of moderate or severe COPD exacerbations during the treatment period.

The study met its primary endpoint demonstrating that QVA149 significantly reduced the rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038).

The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to tiotropiu. The rate of all (mild, moderate, and severe) exacerbations was significantly reduced by 15% with QVA149 compared to glycopyrronium (p=0.0012) and by 14% compared with OL tiotropium (p=0.0017).

All treatments had an acceptable safety profile, and there was no meaningful difference between the treatment groups in the incidence of adverse and serious adverse event reporting, the company said.

During the 64-week study, results showed that lung function, as measured by trough FEV1 was significantly higher with QVA149 compared to glycopyrronium (p<0.0001) and tiotropium (p<0.0001) at each assessment during the treatment period.

Additionally, QVA149 showed significant differences in health-related quality of life during the study as demonstrated by lower St George's Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium (p<0.01), and tiotropium (p<0.05).

The percentages of patients achieving the minimum clinically important (>=4 unit) improvement in SGRQ total scores were higher with QVA149 compared to glycopyrronium (p=0.055) or tiotropium (p=0.051), the company said.

The results were reported online April 23 in Lancet Respiratory Medicine.

SOURCE: http://bit.ly/SyjwTS

Lancet Respir Med 2013