FLAME study evaluating efficacy of Ultibro® Breezhaler® to reduce chronic COPD exacerbations published in NEJM

Results published in the New England Journal of Medicine are anticipated to have important implications for the care of people living with COPD.

DORVAL, QC, June 21, 2016 /CNW/ - Novartis Pharmaceuticals Canada Inc. today announced the New England Journal of Medicine publication of the FLAME study evaluating the efficacy of once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) in reducing chronic obstructive pulmonary disease (COPD) exacerbations. The published FLAME results are anticipated to impact the future management and treatment of COPD patients.

Exacerbations (disease flare-ups), are a sudden worsening of COPD symptoms, and prevention of these flare ups is one of the primary goals of long-term care for COPD patients. These episodes have a detrimental effect on quality of life and disease progression1, contributing to further lung function decline2,3 and, in severe cases, hospitalization4 and even death1.

"Preventing exacerbations preserves the health and quality of life of patients struggling with COPD. The FLAME study results greatly improve our understanding of COPD management," said Dr. Kenneth Chapman, Director of the Asthma and Airway Centre of the University Health Network, Toronto, and Professor of Medicine, University of Toronto. "The FLAME study has demonstrated the ability of a dual bronchodilator, Ultibro® Breezhaler®, to reduce exacerbations without an inhaled corticosteroid. This underscores the importance of the bronchodilator foundation for COPD patients."

FLAME was a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries, including 12 sites in Canada.5

Patients who had COPD with a history of at least one exacerbation in the previous year were randomly assigned to receive, by inhalation, either indacaterol/glycopyrronium bromide 110/50 mcg once-daily or salmeterol/fluticasone 500 mcg twice daily. The primary outcome was the annual rate of all COPD exacerbations.5

About COPD
Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide6 and is the fourth leading cause of death.7 COPD is often considered to be a disease of later years, but estimates suggest that 50 per cent of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation.8

In Canada, 2009-2010 estimates show that four per cent of Canadians aged 35 and older are affected. Cigarette smoking is the primary cause, accounting for 80 per cent of COPD deaths.9

COPD is progressive (usually gets worse over time), and can be a life-threatening disease.6,10 The disease makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life.6,10

Exacerbations of COPD symptoms can be frightening for patients, causing distress, anxiety and the deterioration of quality of life.11 COPD exacerbations are also associated with significant healthcare resource burden and costs12, particularly due to the frequent need for hospitalization. Consequently, the prevention of exacerbations is an important goal in COPD management to improve long-term health status and conserve healthcare resources.13

About Ultibro® Breezhaler®
Ultibro® Breezhaler® 110/50 mcg is a once-daily LABA*/LAMA dual bronchodilator approved in Canada as a maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.14  Ultibro® Breezhaler® is currently approved for use in over 80 countries worldwide, including countries within the EU and Latin America, Japan, Switzerland and Australia.  

About the Novartis COPD portfolio
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 Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler® (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation.15 The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly.14,15

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 2015, the company invested $53 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs more than 700 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit www.novartis.com.  



* a long-acting beta2-adrenergic agonist
a long-acting anticholinergic

  1. Soler-Cataluña JJ, Martinez-Garcia MA, Sanchez PR, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60:925-931.
  2. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002;57:847-52.
  3. Vestbo J, Edwards LD, Scanlon PD, et al. Changes in forced expiratory volume in 1 second over time in COPD. N Engl J Med. 2011;365:1184-92.
  4. Müllerova H, Maselli DJ, Locantore N, et al. Hospitalized exacerbations of COPD: risk factors and outcomes in the ECLIPSE cohort. Chest. 2015;147:999-1007.
  5. Clinicaltrials.gov. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study (FLAME). NCT01782326. Available at: https://clinicaltrials.gov/ct2/show/NCT01782326?term=NCT01782326&rank=1 [Accessed 10 March 2016].
  6. 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 10 March 2016].
  7. World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 10 March 2016].
  8. 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.
  9. PHAC. Fast facts about Chronic Obstructive Pulmonary Disease (COPD) 2011. Available from http://www.phac-aspc.gc.ca/cd-mc/publications/copd-mpoc/pdf/copd-facts-faits-mpoc-2011-eng.pdf. Accessed May 18, 2016.
  10. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2016. Available at: http://goldcopd.org/uploads/users/files/WatermarkedGlobal%20Strategy%202016(1).pdf [Accessed 10 March 2016].
  11. Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic obstructive pulmonary disease—a patients' perspective. Prim Care Respir J. 2006;15:2:102-109.
  12. Toy EL, Gallagher K, Stanley E, et al. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010;7:214-28.
  13. Anzueto A. Impact of exacerbations on COPD. European Respiratory Review. 2010;19:116:113-118.
  14. Ultibro Breezhaler Product Monograph.  Available at: https://www.novartis.ca/en/our-products/pharmaceuticals#ui-id-1=17. Accessed on May 18, 2016.
  15. Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26; 11:2527–2533.


SOURCE Novartis Pharmaceuticals Canada Inc.

For further information: Novartis Media Relations: Corporate communications, 514-633-7873, Communications.camlph@novartis.com; Michael Kohn, Weber Shandwick, 416-642-7914, mkohn@webershandwick.com

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