Phase III Data Showed Novartis Investigational Bronchodilator QAB149 Significantly Improved Lung Function In COPD Patients

The Novartis investigational bronchodilator QAB149 (indacaterol) met the primary efficacy endpoints of improved lung function compared to placebo at 12 weeks in three pivotal phase III studies in chronic obstructive pulmonary disease (COPD) patients. In secondary endpoints of these studies, QAB149 demonstrated clinically relevant lung function improvements within five minutes of the first dose, lasting for 24 hours in COPD patients.



The QAB149 data, which were presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego, are the first from the Phase III INVOLVE, INHANCE and INLIGHT-1 trials. These were three multinational, multi-center, randomized, double-blind, placebo-controlled studies in over 3,800 patients with moderate-to-severe COPD.



"Current management of COPD focuses on the use of bronchodilators to optimize lung function," said Professor Stephen I. Rennard, Pulmonary and Critical Care Medicine, University of Nebraska Medical Center. "As presented at the ATS meeting, QAB149 is a long-acting beta-agonist bronchodilator given once daily that significantly improved both airflow and clinical outcomes. The ability to provide bronchodilation on a once-daily basis will be an important addition to the current therapeutic armamentarium in COPD."



In the six-month INHANCE trial, QAB149 150?µg and 300?µg doses significantly improved lung function at 12 weeks compared to placebo. Improvements [measured by difference in trough forced expiratory volume in one second (FEV1 )] were observed after one day (110mL and 140mL), at the 12 week primary endpoint (both doses 180mL), and at 26 weeks (160mL and 180mL). Results were statistically significant (p