The safety and efficacy profile of Novartis' lung drug Onbrez Breezhaler has received a boost on the back of a new batch of data from Phase III clinical trials testing it alongside Pfizer's Spiriva.

According to data unveiled by the Swiss drugmaker, Onbrez Breezhaler (indacaterol) plus Spiriva (tiotropium) is more effective than Spiriva alone in treatment of patients with chronic obstructive pulmonary disease, the combination having produced a significantly greater improvement in lung function.

Findings of the INTRUST 1 and 2 studies showed significant improvements in lung function of 130 mL and 120 mL respectively for Onbrez Breezhaler plus Spiriva compared to Spiriva alone after 12 weeks of therapy.

In addition, Novartis noted that the reported incidence of side effects and serious side effects was comparable in both treatment groups.

The findings, which were presented at the American Thoracic Society congress in Denver, Colorado, back current COPD treatment guidelines recommending the use of one or more bronchodilators for treating moderate-to-severe disease, Novartis said.

Onbrez Breezhaler is a once-daily long-acting beta-2 agonist (LABA) and Spiriva HandiHaler is a long-acting anti-muscarinic (LAMA). The drugs have different modes of action but both are designed to provide bronchodilation and thereby improve the flow of air to the lungs in patients with COPD, which affects around 210 million people worldwide.

Potential as combo

While previous clinical data already support the safety and effectiveness of Onbrez Breezhaler as a monotherapy COPD, "the latest results indicate that it may have even greater therapeutic potential when combined with another leading class of treatment," commented Trevor Mundel, global head of development at Novartis.

The drug was approved in Europe in November 2009, but is not yet available across the pond. The US Food and Drug Administration is due to complete its review of Onbrez Breezhaler in July, and if approved it will be marketed under the trade name Arcapta Neohaler.