logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
In a move likely to further inflame global trade tensions, President Donald Trump has threatened to impose a 20 percent tariff on all cars imported to the U.S. from the European Union. Trump claimed he would impose the new tariffs unless the EU removes tariffs and trade barriers placed on the U.S. The Federal Reserve has determined that the largest U.S. banks are strongly capitalized and would be able to lend to banks as well as households during a severe global economic recession. This is the fourth straight year that all banks have met the Federal Reserve's standards. The first round of results of the supervisory stress tests were released by the central bank on Thursday. The "safety" driver behind the wheel of a self-driving Uber was streaming a television show on her smartphone up until about the time of a fatal crash in March, according to a report from the Tempe Police Department. Uber's self-driving Volvo SUV, which was traveling at under 44 miles per hour, had struck and killed a pedestrian in Arizona on March 18.
Follow RTT