Novartis presented new data that demonstrated once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide) was superior in reducing exacerbations (flare ups) and improving lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone (SFC)), in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). These findings from the head-to-head LANTERN study were presented for the first time at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany.
The LANTERN study showed Ultibro Breezhaler significantly reduced the rate of moderate-to-severe exacerbations by 31% compared to SFC, in moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year. In addition, Ultibro Breezhaler patients had significantly increased lung function (trough FEV1 0.075 L (p<0.001); AUC0-4h 0.122 L (p<0.001)), as compared to SFC after 26 weeks of treatment. The safety profile of Ultibro Breezhaler was comparable to SFC.
"These new results from LANTERN provide further evidence of the potential of Ultibro Breezhaler to deliver better exacerbation reduction and improvements in lung function, compared to the current standard of care," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals.
The new findings from LANTERN support the use of Ultibro Breezhaler as an alternative steroid-free treatment to SFC in moderate-to-severe COPD patients. This approach is consistent with the Global Initiative for Chronic Obstructive Lung Disease 2014 guidelines.
COPD symptoms can have a major negative impact on a patient's ability to breathe and function, reducing their quality of life. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens. There is a need for newer treatment options in COPD because many patients remain symptomatic despite medical therapy.
LANTERN was a randomized, double-blind, parallel-group, 26-week study involving 744 patients and conducted at 56 sites across China, Argentina, Chile and Taiwan. The primary objective of the study was to demonstrate the non-inferiority of Ultibro Breezhaler 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. In this study, exacerbations were a pre-specified exploratory endpoint.
Ultibro Breezhaler is a once-daily dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. 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 and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 40 countries, including countries within the EU, Japan, Canada, countries within Latin America and Australia.
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 Neohaler (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. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly.