Novartis' INSTEAD Study For Onbrez In COPD Meets Primary Endpoint

Novartis reported top-line results from the Phase IV INSTEAD switch study assessing once-daily Onbrez Breezhaler (indacaterol) 150 mcg in patients with chronic obstructive pulmonary disease (COPD). The trial met its primary endpoint, which was non-inferiority in lung function compared to Seretide (salmeterol/fluticasone propionate (SFC)) 50/500 mcg in patients with moderate COPD and no reported exacerbations in the previous year.

The INSTEAD switch study also demonstrated similar symptomatic benefits after 12 and 26 weeks in terms of shortness of breath and health status of patients treated with Onbrez Breezhaler (indacaterol) versus those who were on SFC. The safety profile of Onbrez Breezhaler was shown to be consistent with those previously reported from Phase III studies.

Tim Wright, Global Head of Development at Novartis Pharmaceuticals, said, “These positive results help inform the switch from salmeterol/fluticasone to Onbrez Breezhaler in patients with moderate COPD and who are at low risk of exacerbations. This confirms that Onbrez Breezhaler provides an effective maintenance treatment option for these patients. In addition, these results support international guidelines, which advise against the use of inhaled corticosteroids due to long-term risks in COPD patients at low risk of exacerbations.”

Chronic obstructive pulmonary disease is projected to be the third leading cause of death worldwide by 2020. The disease affects an estimated 210 million people around the world. Treatments that offer symptom management of COPD and enable patients to continue with their daily activities are crucial in helping to address the unmet needs of patients with COPD.

Onbrez Breezhaler (indacaterol) is a once-daily inhaled long-acting beta2-adrenergic agonist (LABA) that provides clinically relevant 24 hour bronchodilation. The drug acts within five minutes at first dose, as shown in the INERGIZE Phase III trial program. The drug reduced shortness of breath, lowered the use of rescue medication, and improved health status in patients compared with blinded tiotropium 18 mcg.  Onbrez Breezhaler first received approval in the EU for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD.

The company said that it expects to present data from the INSTEAD study at major medical congresses later this year.