logo
Share SHARE
FONT-SIZE Plus   Neg

Novartis Presents Addl Data From Once-daily COPD Clinical Trial Programs

Novartis (NVS) presented additional data from its once-daily chronic obstructive pulmonary disease or COPD clinical trial programs at the European Respiratory Society or ERS Congress.

Novartis said that overall, it presented 14 abstracts, including data from the investigational QVA149 (fixed-dose combination of indacaterol maleate / glycopyrronium bromide) IGNITE Phase III clinical trial program, the glycopyrronium bromide (Seebri Breezhaler) GLOW Phase III clinical trial program and the indacaterol maleate (Onbrez Breezhaler) INERGIZE Phase III/IV clinical trial program.

The data also demonstrated the potential of the Novartis COPD portfolio to provide once-daily, innovative treatment choices for patients and physicians.

The company noted that three new studies from the investigational QVA149 IGNITE Phase III clinical trial program (SHINE, ILLUMINATE and ENLIGHTEN) demonstrated that QVA149 significantly improved lung function compared to other COPD therapies.

Data from the GLOW program showed that glycopyrronium 50 mcg once daily provided rapid and sustained bronchodilation, and reduced exacerbations and symptoms when compared to placebo, similar to the levels observed with open-label or OL tiotropium 18 mcg.

In addition, a new pooled-analysis from the INERGIZE studies showed that Onbrez Breezhaler 300 mcg was superior to OL tiotropium 18 mcg in improving breathlessness in COPD patients who had more severe breathlessness symptoms on entry to the studies (p<0.05).

The company added that SHINE met its primary endpoint by demonstrating that once-daily QVA149 110/50 mcg improved lung function as measured by trough FEV1 compared to once-daily indacaterol maleate 150 mcg (+70mL above indacaterol alone; p<0.001) and once-daily glycopyrronium 50 mcg (+90mL above glycopyrronium alone; p<0.001).

ILLUMINATE compared QVA149 110/50 mcg to the twice-daily LABA/ICS salmeterol/fluticasone 50/500 mcg head-to-head over 26 weeks in patients with COPD.

QVA149 was generally well tolerated in the SHINE, ILLUMINATE and ENLIGHTEN trials with an incidence of adverse events that was similar between respective groups.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
French lender Societe Generale SA reported Thursday higher net profit in its fourth quarter, while operating income declined sharply amid higher litigation provision and lower net banking income. However, fiscal 2015 was marked by good operating performances in all the businesses. Citing the annual results, the company lifted its dividend. Fast-food giant Burger King will be adding hot dogs to its menu in the US from February 23. According to Burger King's North American President Alex Macedo, this addition is the most significant menu addition for the burger chain since it added a chicken sandwich in the 1970s. Burger King will... Electric car maker Tesla Motors Inc. (TSLA), Wednesday reported a fourth-quarter loss that widened from last year, hurt largely by higher operating costs which offset an increase in revenues. However, shares of the company gained 11 percent after the company detailed a strong delivery target for 2016. Tesla,...
comments powered by Disqus
RELATED NEWS
Trade NVS now with 
Follow RTT