Phase III data show Novartis bronchodilator QAB149 improves lung function over current treatments in COPD

26-May-2009 - Switzerland

Initial results from three pivotal phase III trials show the Novartis investigational bronchodilator QAB149 (indacaterol) could deliver clinically relevant lung function improvements, within five minutes of the first dose, lasting for 24 hours in patients with chronic obstructive pulmonary disease (COPD).

The data presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego show that QAB149, a long-acting beta2-agonist (LABA), significantly improved lung function from the first day of therapy to up to one year of treatment. The data also reveal that all evaluated doses of QAB149 were well-tolerated and had a good overall safety profile.

All doses of once-daily QAB149 met the primary efficacy endpoint of significant improvement in FEV1 (forced expiratory volume in one second) versus placebo at twelve weeks. This improvement was seen as early as five minutes post-dose and at every subsequent time point measured in each study. In INVOLVE QAB149 (300µg and 600µg) also showed significant improvements over formoterol 12µg in trough FEV1 difference versus placebo at three months (170ml and 170ml vs. 70ml; p<0.001), and at one year (160ml and 150ml vs. 50ml; p<0.001).

In addition to data presented at ATS, Novartis released data showing that at 12 weeks, QAB149 (150µg and 300µg) achieved additional improvements of 50ml and 40ml, respectively, versus open-label tiotropium 18µg, in trough FEV1 or 24-hour post-dose forced expiratory volume in one second. Further presentation of study results is planned for later this year.

https://www.bionity.com/en/news/101269/phase-iii-data-show-novartis-bronchodilator-qab149-improves-lung-function-over-current-treatments-in-copd.html