Results of the Phase III INSIST study show that Novartis’ Onbrez® Breezhaler® (indacaterol) given once-daily is significantly better at improving lung function and reducing breathlessness than twice-daily salmeterol, one of the current mainstays of treatment for patients with chronic obstructive pulmonary disease (COPD). Patients with COPD using Onbrez Breezhaler were also able to reduce their use of rescue medication compared to those using salmeterol.
While salmeterol is a long-acting beta-2 agonist (LABA), Onbrez Breezhaler has been described as the first ultra-LABA reflecting its longer duration of action compared to older LABAs, Novartis notes. It is approved in more than 40 countries including Australia, India, Indonesia, Korea, Switzerland, countries in the EU, and countries in Latin America. Onbrez Breezhaler is indicated in Europe for the maintenance bronchodilator treatment of airflow obstruction in adult COPD patients. U.S. approval is subject to the FDA's review of additional clinical data that Novartis expects to file by the end of 2010.
The INSIST study was conducted in 1,123 patients aged 40 years or above in seven countries. It was a 12-week, randomized, double-blind, head-to-head study involving patients with moderate-to-severe COPD. The study met its primary endpoint with Onbrez Breezhaler 150 µg once-daily providing superior 24-hour bronchodilation to salmeterol 50 µg twice-daily at the end of 12 weeks' treatment.
In addition, Onbrez Breezhaler significantly increased the proportion of patients with a clinically relevant reduction in breathlessness compared to salmeterol (69.4% vs. 62.7% achieved a score of at least one in the transition dyspnea index) and the number of days on which patients did not require rescue medication (mean difference 4.4%).
The INSIST study findings are supported by recently published data from the 26-week INLIGHT-2 Phase III study involving 1,002 patients with moderate-to-severe COPD. In that study Onbrez Breezhaler 150 µg once-daily provided a greater improvement in lung function after 12 weeks than salmeterol 50 µg twice-daily or placebo.