Major study confirms Novartis' Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations

Ultibro Breezhaler also significantly reduced the rate and prolonged the time to the first moderate or severe exacerbation, compared with Seretide.

Preventing exacerbations is one of the primary goals of long-term care for COPD patients. These episodes have a detrimental effect on quality of life and disease progression, contributing to further lung function decline and, in severe cases, hospitalization and even death.

"Reducing exacerbations is absolutely critical to improve outcomes and quality of life for COPD patients," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "The FLAME study has clearly shown that Ultibro Breezhaler is superior to the current standard of care in reducing exacerbations, marking a shift away from therapies containing steroids for the optimal treatment of COPD patients."

The results of FLAME confirmed that Ultibro Breezhaler is superior to SFC in reducing exacerbation outcomes regardless of a patient's disease severity and eosinophil levels (a type of white blood cell). Significantly, compared with SFC, Ultibro Breezhaler both reduced the rate of moderate or severe exacerbations with a 17% risk reduction (rate ratio, 0.83), and prolonged the time to the first of these episodes with a 22% risk reduction (hazard ratio, 0.78). The safety profiles of the two treatments were consistent with their known profiles. The incidence of pneumonia was higher with SFC than Ultibro Breezhaler (3.2% vs 4.8%: a statistically significant difference).