FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations - Seite 2

Secondary endpoints for the study comparing Ultibro Breezhaler to SFC included superiority in terms of rate of all COPD exacerbations over the study duration and efficacy in terms of the following: time to first COPD exacerbation (mild/moderate/severe); rate and time to first moderate-to-severe COPD exacerbation; lung function (trough FEV₁); health-related quality of life (as measured by the shortened version of the St George's Respiratory Questionnaire [SGRQ-C]); rescue medication use and safety[1].

FLAME is the last of 11 studies in the IGNITE Phase III clinical trial program exploring Ultibro Breezhaler for the treatment of COPD.

About Ultibro Breezhaler
Ultibro Breezhaler 110/50 mcg is a once-daily LABA*/LAMA⁺ dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD[2]. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg[3-5] and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 70 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.  In the U.S. the treatment is approved in a twice-daily formulation of indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg, known as Utibron^(TM) Neohaler^®. 

* a long-acting beta₂-adrenergic agonist
⁺ a long-acting muscarinic antagonist

About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro Breezhaler (indacaterol/glycopyrronium bromide), Seebri^® Breezhaler^® (glycopyrronium bromide) and Onbrez^® Breezhaler^®/Arcapta^TM Neohaler^TM (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler^® inhalation device, which makes it suitable for patients with different severities of airflow limitation[6]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[2,6].