Novartis has presented new data from chronic obstructive pulmonary disease (COPD) portfolio at the American Thoracic Society (ATS) International Conference in Philadelphia. In total, Novartis presented 34 respiratory abstracts, featuring latest findings from the IGNITE clinical trial program including BLAZE and SPARK studies, plus data from pooled GLOW1 and 2 studies.
The late-breaking BLAZE study included patient self-reported data that demonstrated improvements in shortness of breath with investigational once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) when compared to placebo and blinded tiotropium 18 mcg. The SPARK study showed that QVA149 significantly reduced the rate of all COPD exacerbations versus glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg.
"The expanding Novartis COPD portfolio brings us another step closer to meeting the unmet needs of millions of patients worldwide," said Tim Wright, Head of Development, Novartis Pharmaceuticals. "These important results for both QVA149 and Seebri Breezhaler add further weight to our COPD portfolio, providing the right treatment for the right patient at the right time."
COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients' function and quality of life. It affects millions of people worldwide and is projected to be the third leading cause of death by 2020. New treatments which effectively manage COPD are very important to patients and physicians, as COPD can impose a significant burden on patients and reduce quality of life.
The BLAZE study showed that after six weeks of treatment, QVA149 significantly improved patient self-reported shortness of breath during daily activities versus both placebo (p<0.001) and tiotropium 18 mcg (p=0.021). BLAZE was the first study to evaluate direct electronic patient self-reported shortness of breath and showed that QVA149 significantly improved lung function versus placebo and tiotropium 18 mcg (as demonstrated by mean FEV1)at all time points (45 minutes pre-dose to four hours post-dose) after six weeks of treatment (p<0.001).
The SPARK study, recently published in Lancet Respiratory Medicine, demonstrated that QVA149 significantly reduced the rate of all COPD exacerbations (mild, moderate and severe) by 15 per cent versus glycopyrronium 50 mcg (p=0.0012) and 14 per cent versus OL tiotropium 18 mcg (p=0.0017). The primary endpoint of the study was also met since QVA149 demonstrated a significantly reduced rate of moderate or severe COPD exacerbations by 12 per cent versus glycopyrronium (p=0.038). The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg. SPARK also showed that patients receiving QVA149 had substantially improved lung function (measured by trough FEV1)compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg (both p<0.0001). In addition, QVA149 showed significant differences in health-related quality of life as demonstrated by St George's Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium 50 mcg (p<0.01) and OL tiotropium 18 mcg (p<0.05).
All treatments in the BLAZE and SPARK studies had an acceptable safety profile with no meaningful differences between the treatment groups in the incidence of adverse or serious adverse events.
In a pooled analysis of GLOW1 and GLOW2 data, once-daily glycopyrronium 50 mcg (Seebri Breezhaler) demonstrated significant improvements in lung function during first four hours following morning administration (measured by FEV1 AUC0-4h) versus placebo and OL tiotropium 18 mcg, at Day 1, 12 weeks and 26 weeks. Once-daily glycopyrronium 50 mcg also demonstrated sustained improvements in lung function (measured by trough FEV1) versus placebo over the long term. Glycopyrronium 50 mcg was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium 18 mcg.
BLAZE was a six-week, multi-centre, blinded, double-dummy, placebo-controlled, three-period crossover study. Patients with moderate to severe COPD (N=247) were randomized to once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg), tiotropium 18 mcg or placebo to assess the effect of QVA149 on patient self-reported shortness of breath.
SPARK was a 64-week, multi-centre, double-blind, parallel-group, active controlled study assessing QVA149 (indacaterol maleate 110 mcg/ glycopyrronium 50 mcg) versus glycopyrronium 50 mcg and OL tiotropium 18 mcg on the rate of moderate to severe COPD exacerbations in 2,224 patients, >=40 years with severe to very severe COPD.
GLOW1 and GLOW2 were multicenter, randomized, double-blind, placebo-controlled, parallel group studies in patients with moderate to severe COPD. GLOW1 was a 26 week study with 822 patients randomized to receive once-daily glycopyrronium 50 mcg (Seebri Breezhaler) or placebo. GLOW2 was a 52 week study with 1,066 patients randomized to receive once-daily glycopyrronium 50 mcg or placebo, and included an exploratory arm to compare the effects of once-daily OL tiotropium 18 mcg versus placebo and glycopyrronium 50 mcg.
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 company continues development of respiratory products for delivery via a platform called the Breezhaler device. This is a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it suitable for patients with airflow limitation. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly.