In total, Novartis presented 34 respiratory abstracts, featuring latest findings from the IGNITE clinical trial program including BLAZE and SPARK[2,3,6,7] studies, plus data from pooled GLOW1 and two studies.[4,8,9,10]
The late-breaking BLAZE study included patient self-reported data that demonstrated improvements in shortness of breath with investigational once-daily QVA149 (indacaterol maleate 110mcg/glycopyrronium 50mcg) when compared to placebo and blinded tiotropium 18mcg. The SPARK study showed that QVA149 significantly reduced the rate of all COPD exacerbations versus glycopyrronium 50mcg and open-label (OL) tiotropium 18mug.[2,3]
“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 affects an estimated 210 million 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.[12,13]
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 18mcg (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 18mcg (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% versus glycopyrronium 50mcg (p=0.0012) and 14% versus OL tiotropium 18mcg (p=0.0017).[2,3]
The primary endpoint of the study was also met since QVA149 demonstrated a significantly reduced rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038).[2,3] The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18mug.[2,3] SPARK also showed that patients receiving QVA149 had substantially improved lung function (measured by trough FEV1)compared to glycopyrronium 50mcg and OL tiotropium 18mcg (both p<0.0001).[2,6] 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 50mcg (p<0.01) and OL tiotropium 18 mcg (p<0.05).[2,6]
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.[1,2,7]
In a pooled analysis of GLOW1 and GLOW2 data, once-daily glycopyrronium 50mcg (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 18mcg, at Day 1, 12 weeks and 26 weeks. Once-daily glycopyrronium 50mcg also demonstrated sustained improvements in lung function (measured by trough FEV1) versus placebo over the long term. Glycopyrronium 50mcg was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium 18mcg.
- Mahler D et al. Superior lung function with once-daily QVA149 translates into improvements in patient reported breathlessness compared with placebo and tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308; Session C20; Date: May 21, 2013 Time: 8:15-10:45].
- Wedzicha W et al. Efficacy and safety of QVA149 versus glycopyrronium and tiotropium in severe to very severe COPD: the SPARK study. [ATS abstract 40727; Session B23; Date: May 20, 2013 Time: 8:15 -9:15].
- Wedzicha W et al. Dual bronchodilation with QVA149 reduces COPD exacerbations: the SPARK study. [ATS abstract 40759; Session B23; Date: May 20, 2013 Time: 8:15 -9:15].
- Roche N et al. Rapid bronchodilation with once-daily glycopyrronium: the importance of optimizing lung function in the morning. [ATS abstract 40403; Session C45; Date: May 21, 2013 Time: 10:45-12:30].
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Last accessed 2 May 2013.
- Decramer M et al. Once-daily QVA149 improves health-related quality of life in patients with severe to very severe COPD: the SPARK study. [ATS abstract 40786; Session C45; Date: May 21, 2013 Time: 10:45-12:30].
- Decramer M et al. Safety and tolerability of QVA149, glycopyrronium and tiotropium in patients with severe to very severe COPD: the SPARK study. [ATS abstract 41616; Session A43; Date: May 19, 2013 Time: 10:45-12:30].
- D’Urzo A et al. Glycopyrronium once daily provides sustained bronchodilation and improves symptoms in various subgroups of patients with COPD. [ATS abstract 40505; Session C45; Date: May 21, 2013 Time: 10:45-12:30].
- Kerwin E et al. Glycopyrronium is safe and well tolerated in patients with moderate-to-severe COPD. [ATS abstract 40518; Session C45; Date: May 21, 2013 Time: 10:45-12:30].
- D’Urzo A et al. Glycopyrronium once daily improves patient-reported symptom scores in patients with COPD. [ATS abstract 40519; Session C45; Date: May 21, 2013 Time: 10:45-12:30].
- Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf. Last accessed 2 May 2013.
- Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.
- daCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280. Last accessed 2 May 2013.
- Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respir Med 2013 http://www.thelancet.com/journals/lanres/onlinefirst Last Accessed 2 May 2013