Date: 2014-09-07
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at ERS International Congress 2014, the annual meeting of the European Respiratory Society.
Company: Novartis (Switzerland)
Product: Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide)
Action
mechanism: 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. The drug is a fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237). Indacaterol activates the relaxation of the muscles of the airways, and glycopyrronium blocks the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. 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[8],[9],[10] 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.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Inflammatory diseases - Respiratory diseases
Country: Argentina, Chile, China, Taiwan
Trial
details: 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.
Latest
news: * On September 7, 2014, Novartis presented new data that demonstrated once-daily Ultibro® Breezhaler® 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. 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.
