LANTERN study met primary endpoint demonstrating non-inferiority of
Ultibro® Breezhaler® 110/50 mcg vs Advair* Diskus* (SFC) 50/500 mcg followed by
statistically significant superiority in post dose trough FEV1 after 26 weeks of treatment in patients with moderate-to-severe COPD1
In addition, LANTERN study met an endpoint demonstrating that Ultibro® Breezhaler® reduced exacerbations by 31 per cent vs twice-daily Advair* Diskus* in
moderate-to-severe COPD patients1
First presentation of LANTERN trial at European Respiratory Society
(ERS) International Congress involving over 700 COPD patients1
DORVAL, QC, Sept. 8, 2014 /CNW/ - Novartis, announces today new data
from the LANTERN study that demonstrated Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide, QVA149) was superior in
bronchodilation and rate of exacerbations vs Advair* Diskus*
(salmeterol/fluticasone, (SFC)).1 The head-to-head LANTERN study results were presented for the first
time at the European Respiratory Society (ERS) International Congress,
September 6-10, in Munich, Germany.
"Until now, we've regarded inhaled steroids as a necessary component in
the treatment of severe COPD," says Dr. Kenneth Chapman, Director,
Asthma & Airway Centre of the University Health Network, located in
Toronto. "The findings from LANTERN will encourage us to consider a
steroid-free dual bronchodilator regimen in COPD patients with moderate
to severe disease, a strategy consistent with the Global Initiative for
Chronic Obstructive Lung Disease (GOLD) 2014 recommendations.
Certainly, Ultibro® improved several health outcomes, including exacerbation reduction,
more effectively than a widely used inhaled steroid containing
combination regimen, SFC."
LANTERN was a randomized, double blind, parallel group, 26-week study
involving 744 patients and was conducted at 56 sites across China,
Argentina, Chile and Taiwan.4 The results of the LANTERN study demonstrated the efficacy of
once-daily Ultibro® Breezhaler® was superior and clinically meaningful compared to twice-daily SFC in
terms of lung function (trough FEV1; AUC0-4h), in patients with moderate-to-severe COPD after 26 weeks of treatment.
These findings further demonstrated the use of a LABA/LAAC combination
over LABA/inhaled corticosteroid in moderate-to-severe COPD patients
with or without exacerbation and are consistent with the current GOLD
The primary objective of the study was to demonstrate the
non-inferiority of Ultibro® Breezhaler® 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough FEV1) after 26 weeks of treatment in patients with moderate-to-severe COPD,
with no more than one exacerbation in the previous year.1 Ultibro® Breezhaler® met its primary objective of non-inferiority. Additionally, the LANTERN
study showed Ultibro® Breezhaler® significantly reduced the rate of moderate-to-severe exacerbations by 31
per cent compared to SFC, in moderate-to-severe COPD patients with a
history of one exacerbation or none in the previous year.1
The safety profile of Ultibro® Breezhaler® was comparable to SFC.1 Adverse events were lower for Ultibro® Breezhaler® (40.17%) vs SFC (47.4%) and incidence of pneumonia were also lower with
Ultibro® Breezhaler® (0.8%) vs SFC (2.7%). The safety profile in this study is similar to the
overall safety profile for this product.
COPD is a progressive life-threatening disease that makes it hard to
breathe, with symptoms that have a destructive impact on patients' lung
function and quality of life.3,5 Essential daily activities such as climbing stairs can become very
difficult as the condition gradually worsens.6 It affects an estimated 210 million people worldwide7 and is projected to be the third leading cause of death by 2020.3 In Canada, 2009-2010 estimates show that 4 per cent of Canadians aged
35 and older are affected. Cigarette smoking is the principal cause,
accounting for 80 per cent of COPD deaths.8
COPD is often considered to be a disease of later years, but estimates
suggest that 50% of those with COPD are now less than 65 years old,
resulting in increases in absenteeism, premature retirement and
reductions in workforce participation.9 COPD symptoms can impose a significant burden on patients and reduce
quality of life.9,10 There is a need for newer treatment options in COPD because many
patients remain symptomatic despite medical therapy.11
About Ultibro® Breezhaler®
Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide, QVA149) is a fixed-dose
combination (FDC) of the active ingredients of two bronchodilators,
Onbrez® Breezhaler® (indacaterol maleate), a long-acting beta2-adrenergic agonist (LABA)12 and Seebri® Breezhaler® (glycopyrronium bromide), a long-acting anticholinergic (LAAC).13 Both are currently used by healthcare professionals as individual
therapies to treat COPD in Canada.
Ultibro® Breezhaler® is approved as a maintenance bronchodilator treatment of airflow
obstruction in patients with COPD, including chronic bronchitis and
emphysema but not for COPD exacerbation reduction.2 Ultibro® Breezhaler® is currently approved for use in over 40 countries, including the EU,
Japan, Australia and other countries in Latin America.
About the Novartis COPD portfolio
Novartis is committed to addressing the medical needs of patients with
respiratory diseases and improving their quality of life by providing
innovative medicines and devices.
About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2012, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. For further information, please consult www.novartis.ca.
Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG,
which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis Group of Companies offers a diversified portfolio
to best meet these needs: innovative medicines, eye care, cost-saving
generic pharmaceuticals, preventive vaccines, over-the-counter and
animal health products. Novartis is the only global company with
leading positions in these areas. In 2013, the Group achieved net sales
of USD 57.9 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately
135,000 full-time equivalent associates and sell products in more than
150 countries around the world. For more information, please visit www.novartis.com.
® Ultibro, Onbrez, Seebri and Breezhaler are registered trademarks
* All trademarks and registered trademarks are the property of their
Zhong N et al. Efficacy and safety of once-daily QVA149 compared with twice-daily
salmeterol/fluticasone combination (SFC) in patients with COPD: the
LANTERN study. [ERS abstract 700090; Session 281; Date: September 8
2014 Time: 12:50-14:40].
Ultibro® Breezhaler® Product Monograph, August 18, 2014.
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Pulmonary Disease. Updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf [Accessed 21 August 2014].
Clinicaltrials.gov. A 26-week Treatment Randomized, Double-blind, Double
Dummy Study to Assess the Efficacy and Safety of QVA149 (LANTERN).
NCT01709903. http://clinicaltrials.gov/ct2/show/NCT01709903 [Accessed 23 July 2014].
Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive
pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.
World Health Organization. Chronic Obstructive Pulmonary Disease
Factsheet No. 315, Available at: http://www.who.int/mediacentre/factsheets/fs315/en/. [Accessed 5 August 2014].
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_Manual/en/. [Accessed 21 August 2014].
PHAC. Fast facts about Chronic Obstructive Pulmonary Disease (COPD)
2011. Available from: www.phac-aspc.gc.ca/cd-mc/publications/copd-mpoc/ff-rr-2011-eng.php [Accessed 21 August 2014].
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. [Accessed 21 August 2014].
Hersh CP. Pharmacogenetics of chronic obstructive pulmonary disease:
challenges and opportunities. Pharmacogenomics 2010;11(2):237-247.
Onbrez® Breezhaler® Product Monograph, December 3, 2013.
Seebri® Breezhaler® Product Monograph, August 7, 2014.
SOURCE: Novartis Pharmaceuticals Canada Inc.
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