Novartis Study Shows Onbrez® Breezhaler® Is Superior To Salmeterol In Reducing Breathlessness For Patients With COPD

Results of the Phase III INSIST study show that Onbrez® Breezhaler® (indacaterol) given once-daily is significantly better at improving lung function and reducing breathlessness than twice-daily salmeterol[1], one of the current mainstays of treatment for patients with chronic obstructive pulmonary disease (COPD).


Patients with COPD using the novel Onbrez Breezhaler were also able to reduce their use of rescue medication compared to those using salmeterol[1], a widely prescribed drug in the long-acting beta-2 agonist (LABA) class. Onbrez Breezhaler has been described in scientific literature as the first "ultra-LABA" reflecting its longer duration of action compared to older LABAs[2].


Data from the INSIST study involving 1,123 patients aged 40 years or above in seven countries were presented today at the European Respiratory Society (ERS) congress in Barcelona, Spain. Results showed that Onbrez Breezhaler 150 ?µg once-daily provided superior 24-hour bronchodilation to salmeterol 50 ?µg twice-daily at the end of 12 weeks' treatment[1].


"Patients with COPD require treatment that combines a sustained improvement in lung function with better clinical outcomes," said the study's principal investigator, Dr Stephanie Korn from the Pulmonary Department at Mainz University Hospital in Germany. "The results of INSIST confirm that indacaterol is potentially an attractive maintenance treatment option for these patients."


COPD is a progressive, life-threatening disease associated with tobacco smoking, air pollution or occupational exposure, which causes obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. Although often considered a disease of the elderly, research has shown that a majority of COPD patients are under the age of 65[3], when they are likely to be at the peak of their earning power and family responsibilities.


INSIST was a 12-week, randomized, double-blind, head-to-head study involving patients with moderate-to-severe COPD (as defined by the GOLD 2007 criteria[4]). The study met its primary endpoint with Onbrez Breezhaler giving superior bronchodilation to salmeterol at week 12[1]. This was assessed by measuring patients' forced expiratory volume of breath in one second (FEV1) from five minutes to 11 hours 45 minutes post-dose (mean difference in FEV1 area under curve 60 mL, p







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[5]. In this 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 (24-hour trough FEV1 increased by 60 mL more than salmeterol and 170 mL more than placebo, both p