Novartis’ new analyses reinforce the potential of Ultibro® Breezhaler® for COPD patients historically treated with steroids

  • New analyses from the FLAME study suggest dual bronchodilator Ultibro® Breezhaler® provides similar or better efficacy versus steroid-containing therapies, regardless of blood eosinophil (a type of white blood cell) counts
  • Data was published in the centenary issue of the American Thoracic Society’s ‘American Journal of Respiratory and Critical Care Medicine’
  • Together with the International Primary Care Respiratory Group, Novartis is launching physician guidance to support a deeper evaluation of inhaled steroid use in COPD patients

Basel, May 23, 2017 Further analyses of Novartis’ head-to-head FLAME study suggest that inhaled corticosteroids (ICS) may not be needed in some chronic obstructive pulmonary disease (COPD) patients with high blood eosinophil (a type of white blood cell) counts. The new data showed that Ultibro®Breezhaler® consistently provided superior or similar benefits over Seretide®* in COPD patients regardless of the eosinophil count[1]. These results contrast with data suggesting better clinical outcomes with ICS therapies for patients with high eosinophil counts[2]-[5]. The data was published in the centenary issue of the American Thoracic Society’s ‘Blue Journal’**[1] and solidifies the need for individualized risk-benefit assessments when considering ICS treatments.

The potential for high blood eosinophil counts to be considered as a biomarker to direct the use of a LABA***/ICS combination over dual bronchodilation (LABA/LAMA****) in some patients, has been referenced in the 2017 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report[6]. FLAME was the first trial to prospectively study the influence of blood eosinophils on the efficacy of ICS-containing therapies versus a LABA/LAMA. The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%[1]. In addition, at no cut-off was Seretide more effective than Ultibro Breezhaler[1].

“These new FLAME study analyses provide evidence that an effective dual bronchodilator such as Ultibro Breezhaler can provide similar or better benefits in patients with high eosinophil counts who may have been considered for an inhaled steroid-containing treatment,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “The data highlight the opportunity to allow more patients to avoid unnecessary exposure steroid-containing regimens and the significant potential associated risks.”

With funding support from Novartis, the International Primary Care Respiratory Group (IPCRG) is addressing the appropriate use and safe withdrawal of ICS in COPD patients with the launch of a primary care physician guide. The guide was launched at the recent IPCRG conference in Slovenia and aims to ensure the latest evidence based treatment guidance from the 2017 GOLD report is translated into daily clinical practice. The guide is accessible on the IPCRG website here:




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