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

9/3/2012 1:49 AM ET

Novartis (NVS: Quote) 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.

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by RTT Staff Writer

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