Novartis has announced that two phase III studies show that patients with Chronic Obstructive Pulmonary Disease (COPD) who were treated with once-daily Onbrez Breezhaler (indacaterol) plus tiotropium experienced significantly greater improvements in lung function than those treated with tiotropium alone.

The Intrust 1 and 2 studies met their primary endpoints by demonstrating significant improvements in lung function, measured by forced expiratory volume of breath in one second (FEV1), for Onbrez Breezhaler plus tiotropium compared to tiotropium alone after 12 weeks (both p<0.001).

“Previous studies have confirmed the efficacy of Onbrez Breezhaler as monotherapy, and these data show the potential for additional lung function benefits when two of the leading classes of treatment for COPD are combined,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “These data support the treatment approach of combining bronchodilators of different classes as recommended in the internationally recognized GOLD guidelines for managing COPD.”

Onbrez Breezhaler is the only marketed once-daily Long-Acting Beta-2 Agonist (LABA), while tiotropium (Spiriva HandiHaler) is a Long-Acting Anti-Muscarinic (LAMA), both indicated for the treatment of COPD. The two classes of medicines have different modes of action but both therapies are inhaled to provide bronchodilation, i.e. increased airflow into the patient's lungs.

Intrust 1 and 2 were matching 12-week, randomized, double-blind studies involving a total of 2,276 patients with moderate-to-severe COPD (as defined by the GOLD 2007 criteria). One group of patients received Onbrez Breezhaler 150 mcg once-daily, while the other group received placebo. All patients concurrently received open-label tiotropium 18 mcg once-daily. The incidence of adverse events was similar for the two arms of the studies. Efficacy and safety data will be presented at the American Thoracic Society congress in Denver, Colorado in May 2011.

Onbrez Breezhaler was first approved in November 2009 in the European Union, where it is indicated for the maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD. It is now approved in more than 50 countries and has been launched in 13 European countries, with additional launches planned in 2011. The application for US approval (under the trade name Arcapta Neohaler) is expected to be reviewed by an FDA Advisory Committee in March 2011.